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Improvisational Movement for People With Memory Loss and Their Caregivers (IMOVE)

Primary Purpose

Alzheimer's Disease (Incl Subtypes), Dementia, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance Group
Non-Group Dance
Social Group
No Contact
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease (Incl Subtypes) focused on measuring Improvisation, Memory loss, Caregivers, Quality of Life, Dance, Social Group, MRI, mild cognitive impairment, MCI, Social engagement

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 60-85 years

Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type

MRI compatible

English speaking

Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner.

Able to attend bi-weekly intervention classes or come to study visits for no-contact control.

Not enrolled in another interventional study for at least 3 months prior to beginning this study.

Exclusion Criteria:

Untreated depression

Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia)

Current cancer treatment or other major medical problems that might independently affect cognition or movement

Other neurological disorders (e.g., Parkinson disease, multiple sclerosis)

Taking medication that could negatively influence safety during intervention

Planned extensive travel during the study period

Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Dance Group

Non-group Dance

Social Group

No Contact

Arm Description

The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing.

The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week.

The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.

A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks

Outcomes

Primary Outcome Measures

Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)
Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.
QOL-AD--PWD
Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Secondary Outcome Measures

Community Structure--PWD
This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Community Structure--PWD
This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Global Efficiency (eGlob)--PWD
This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Global Efficiency (eGlob)--PWD
This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Local Efficiency (eLoc)--PWD
Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Local Efficiency (eLoc)--PWD
Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Path Length--PWD
Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Path Length--PWD
Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Fullerton Advanced Balance Scale (Overall Balance) PWD
Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Fullerton Advanced Balance Scale (Overall Balance) PWD
Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Falls Efficacy Scale - International (FES) PWD
A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Falls Efficacy Scale - International (FES) PWD
A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
NPI-Q
The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
Geriatric Depression Scale
The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Geriatric Depression Scale
The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Geriatric Anxiety Scale
The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Geriatric Anxiety Scale
The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Apathy Evaluation Scale--PWD
The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Apathy Evaluation Scale--PWD
The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Expanded Short Physical Performance Battery (eSPPB)
The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Expanded Short Physical Performance Battery (eSPPB)
The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Postural Sway--PWD
Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Postural Sway--PWD
Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Gait Speed--PWD
The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Gait Speed--PWD
The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Gait Variability--PWD
Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.
Gait Variability--PWD
Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.

Full Information

First Posted
November 1, 2017
Last Updated
July 26, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03333837
Brief Title
Improvisational Movement for People With Memory Loss and Their Caregivers
Acronym
IMOVE
Official Title
IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.
Detailed Description
Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Alzheimer's disease is the most common form of dementia, the most common neurodegenerative disease in older adults, and the 6th leading cause of death in the US. Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance are prominent secondary symptoms of Alzheimer's disease that increase medical costs and decrease quality of life for both the person with dementia and their caregiver. In a report from the Secretariat (Executive Board, 134th Session, December 20th, 2013), the World Health Organization identified a need to integrate evidence-based palliative care services into the continuum of care for serious chronic diseases, including Alzheimer's disease. However, two recent NIH workshops identified major gaps in the evidence supporting the wider use of non-pharmacologic activities to ameliorate secondary symptoms of chronic disease. Arts-based activities were identified as particularly understudied for symptom management, given growing evidence that various arts-based activities can improve quality of life, relieve symptoms, and reduce reliance on medications. It is important that these benefits can be achieved without adding medications. Dance is an arts-based activity that can improve quality of life, decrease symptoms of depression, and improve balance in healthy older adults, those with Parkinson disease, and Alzheimer's disease. Thus, dance is a non-pharmacological intervention that simultaneously addresses two sets of prominent secondary symptoms in Alzheimer's disease: 1) gait and balance and 2) neuropsychiatric symptoms. However, the mechanisms through which dance exerts these effects are unknown. Pilot data from the investigators' laboratory suggest that participating in a group improvisational movement class twice weekly improved balance and connectivity in motor-related brain regions, as well as improving mood and connectivity in brain regions associated with social engagement. Improvisation is the ability to create new gestures and movements spontaneously. Improvisation can be a part of many different art forms. However, improvisational movement can also be practiced as a specific dance form. The objective in improvisational movement is that choreographed movement is replaced by a cue or prompt that allows the possibility for multiple responses. This unique form of dance is especially well-suited for people with dementia because it: 1) does not rely heavily on memory of repeated movements; 2) can be seamlessly adapted to include sitting, standing, or moving around the room; 3) is cognitively challenging; and 4) fosters a social, playful atmosphere. Participants seemed to benefit from both the social nature of the class and the movement. Therefore, the overall aim of this proposal is to experimentally determine the independent and combined effects of dance movement and social engagement on quality of life in people with early stage dementia, and test the neural mechanisms of these effects. To accomplish this goal, the investigators will use a 2x2 factorial design and randomize 120 community-dwelling older adults adjudicated as having early-stage dementia of the presumed Alzheimer's type to one of four 3-month interventions: 1) Dance Group, 2) Non-group Dance, 3) Social Group, or 4) No Contact Control. It is not hypothesized that dance affects the underlying disease course, and therefore no improvement is expected in cognition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (Incl Subtypes), Dementia, Mild Cognitive Impairment
Keywords
Improvisation, Memory loss, Caregivers, Quality of Life, Dance, Social Group, MRI, mild cognitive impairment, MCI, Social engagement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial. Investigators will use a 2x2 factorial design to test the separate and combined effects of social engagement and dance movement on QoL in 120 community-dwelling older adults adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of the presumed AD or mixed AD/vascular type. Participants will be randomized to one of four 12-week interventions: 1) Dance Group 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.
Masking
Outcomes Assessor
Masking Description
All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance Group
Arm Type
Active Comparator
Arm Description
The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing.
Arm Title
Non-group Dance
Arm Type
Active Comparator
Arm Description
The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week.
Arm Title
Social Group
Arm Type
Active Comparator
Arm Description
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Arm Title
No Contact
Arm Type
Sham Comparator
Arm Description
A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Dance Group
Intervention Description
Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
Intervention Type
Behavioral
Intervention Name(s)
Non-Group Dance
Intervention Description
The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
Intervention Type
Behavioral
Intervention Name(s)
Social Group
Intervention Description
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
Intervention Type
Behavioral
Intervention Name(s)
No Contact
Intervention Description
The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Primary Outcome Measure Information:
Title
Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)
Description
Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.
Time Frame
Baseline
Title
QOL-AD--PWD
Description
Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Community Structure--PWD
Description
This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Time Frame
Baseline
Title
Community Structure--PWD
Description
This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Time Frame
Week 12
Title
Global Efficiency (eGlob)--PWD
Description
This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Time Frame
Baseline
Title
Global Efficiency (eGlob)--PWD
Description
This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Time Frame
Week 12
Title
Local Efficiency (eLoc)--PWD
Description
Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Time Frame
Baseline
Title
Local Efficiency (eLoc)--PWD
Description
Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Time Frame
Week 12
Title
Path Length--PWD
Description
Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Time Frame
Baseline
Title
Path Length--PWD
Description
Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Time Frame
Week 12
Title
Fullerton Advanced Balance Scale (Overall Balance) PWD
Description
Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Time Frame
Baseline
Title
Fullerton Advanced Balance Scale (Overall Balance) PWD
Description
Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Time Frame
Week 12
Title
Falls Efficacy Scale - International (FES) PWD
Description
A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Time Frame
Baseline
Title
Falls Efficacy Scale - International (FES) PWD
Description
A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Time Frame
Week 12
Title
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Description
The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
Time Frame
Baseline
Title
NPI-Q
Description
The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
Time Frame
Week 12
Title
Geriatric Depression Scale
Description
The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Time Frame
Baseline
Title
Geriatric Depression Scale
Description
The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Time Frame
Week 12
Title
Geriatric Anxiety Scale
Description
The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Time Frame
Baseline
Title
Geriatric Anxiety Scale
Description
The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Time Frame
Week 12
Title
Apathy Evaluation Scale--PWD
Description
The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Time Frame
Baseline
Title
Apathy Evaluation Scale--PWD
Description
The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Time Frame
Week 12
Title
Expanded Short Physical Performance Battery (eSPPB)
Description
The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Time Frame
Baseline
Title
Expanded Short Physical Performance Battery (eSPPB)
Description
The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Time Frame
Week 12
Title
Postural Sway--PWD
Description
Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Time Frame
Baseline
Title
Postural Sway--PWD
Description
Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Time Frame
Week 12
Title
Gait Speed--PWD
Description
The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Time Frame
Baseline
Title
Gait Speed--PWD
Description
The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Time Frame
Week 12
Title
Gait Variability--PWD
Description
Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.
Time Frame
Baseline
Title
Gait Variability--PWD
Description
Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Body Mass Index (BMI)
Description
a measure of body fat based on height and weight that applies to adult men and women--PWD only
Time Frame
Baseline, Week 12
Title
Blood Pressure
Description
PWD only
Time Frame
Baseline, Week12
Title
Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI)
Description
A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only
Time Frame
Baseline
Title
White Matter Lesion Burden
Description
The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only.
Time Frame
Baseline, Week 12
Title
Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis)
Description
Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only
Time Frame
Baseline, Week 12
Title
Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis
Description
The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.
Time Frame
Baseline, Week 12
Title
Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis
Description
The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 60-85 years Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type MRI compatible English speaking Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner. Able to attend bi-weekly intervention classes or come to study visits for no-contact control. Not enrolled in another interventional study for at least 3 months prior to beginning this study. Exclusion Criteria: Untreated depression Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia) Current cancer treatment or other major medical problems that might independently affect cognition or movement Other neurological disorders (e.g., Parkinson disease, multiple sclerosis) Taking medication that could negatively influence safety during intervention Planned extensive travel during the study period Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Hugenschmidt, PhD
Organizational Affiliation
Assistant Professor Gerontology and Geriatric Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Improvisational Movement for People With Memory Loss and Their Caregivers

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