Back to resultsA Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment, Accidental Falls, Aging
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dual-task tai ji quan
standard tai ji quan
stretching
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Falls, Exercise, Dual tasking
Eligibility Criteria
Inclusion Criteria: being 65 years and older having complaint of memory loss scoring ≤0.5 on Clinical Dementia Scale having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test Exclusion Criteria: scoring <24 on the Mini-Mental State Examination being able to ambulate independently for household distances having medical clearance having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis being unwilling to be randomized
Sites / Locations
- Oregon Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dual-task taj ji quan
Standard tai ji quan
Stretching exercise
Arm Description
This intervention includes training of (a) symmetrical postural tai ji quan forms/movements synchronized with breathing, (b) controlled displacement (weight-shifting) of the body's center of mass over the base of support, (c) dynamic eye-hand movements during whole-body motion, (d) multidirectional (anterior-posterior and medial-lateral) stepping, and (e) rotational ankle sway and self-induced reactive postural recovery actions. The training practices are integrated, gradually over time, with a mix of interactive, cognitively stimulating, dual-task exercises that challenge attention control, working memory, verbalization, response inhibition, processing speed, dual tasking, task switching/prioritization, and spatial orientation and postural awareness.
This intervention includes training of tai ji quan forms with synchronized breathing, supplemented by a set of mini-therapeutic exercises. The training involves repeated practice of (a) symmetrical, coordinated, trunk-driven tai ji quan form movements, (b) controlled displacement (weight-shifting) of the body's center of mass over varying sizes of the base of support, (c) dynamic eye-hand movements during whole-body motion, and (d) multidirectional (anterior-posterior and medial-lateral) stepping. As a balance training therapy, movement practices emphasize a dynamic interplay of stabilizing and self-induced destabilizing postural actions and balance exercises that target mobility, stability limits, and sensory integration.
This active control intervention includes light activities that consist of breathing, stretching, and relaxation exercises. Each exercise session encompasses a variety of light and static stretches for joints and muscles, performed in a seated or standing position. Exercise involves the upper body (arms, neck, upper back, shoulder, back, and chest), lower extremities (quadriceps, hamstrings/calfs, and hips), and gentle and slow trunk rotations. Also included are intermittent light walking, deep abdominal breathing exercises that emphasize inhaling and exhaling to maximum capacity, and progressive relaxation of major muscle groups.
Outcomes
Primary Outcome Measures
Self-reported number of falls
This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors
Secondary Outcome Measures
Short Physical Performance Battery
Reflects change in lower extremity function with intervention. This is measured by Short Physical Performance Battery which involves three functional tasks: static balance, gait speed, and getting in and out of a chair, with scores ranging from 0 (worst performance) to 12 (best performance).
Timed Up and Go (TUG)
Reflects change in lower extremity physical function with intervention. This is measured by the Timed Up and Go test (TUG; in seconds) which assesses mobility and fall risk. The test measures the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower scores represent better lower extremity physical function.
Dual-task walking
Reflects change in dual-task costs in gait speed with intervention. The TUG test protocol will be repeated under a dual-task condition where the participant is asked to walk while performing an arithmetic task (i.e., starting at the number 81 and sequentially subtracting 5 from the resulting number). Lower scores on this walk indicate better performance. Dual-task walking cost is defined as the difference between single- and dual-task walking speed, expressed in percentage, with less negative values representing improvement in dual-task walking speed relative to single-task walking.
30-second chair stand
Reflects change in lower extremity strength and endurance with intervention. This is measured by the 30-second chair stand test. The test is conducted by asking the participant to stand up from a chair and sit down fully and to perform as many cycles of sit-to-stand-to-sit as possible in 30 seconds. Higher scores (number of stands) represent higher levels of strength and endurance.
Montreal Cognitive Assessment (MoCA)
Reflects change in global cognitive function. This is measured by MoCA which measures cognitive function of multiple domains (attention/concentration, executive functions, short term memory, language, visuospatial abilities, orientation to time and place). MoCA has a total score that ranges from 0 to 30, with higher scores representing better cognitive functioning.
Trail Making (A, B)
Reflects change in executive function with intervention. This is measured by Trail Making Test (TMT) which consists of two parts (A and B). In Part A, the participant is asked to count the number (1 through 25) off the screen out loud as quickly as possible. In Part B, the participant is asked to recite numbers and letters in an alternating sequence (1-A-2-B-3-C . . . 12-L) as quickly as possible. Errors are corrected immediate with the clock running. For Parts A and B, scoring is expressed in terms of the time (in seconds) to completion. The difference in time taken to complete Part B versus Part A is calculated to form a measure of executive function, with smaller difference scores indicating better executive function.
Category Fluency
Reflects change in memory with intervention. This is measured by a category fluency test in which the participant is asked to generate the names of as many animals as possible in 60 seconds.
Forward Digit Span
Reflects change in attention with intervention. This is measured by Forward Digit Span test. During the test, the participant is asked to repeat a series of digits in the order given. The maximum raw score is 16, with higher scores indicating better attention.
Backward Digit Span
Reflects change in short-term working memory with intervention. This is measured by Backward Digit Span test. During the test, the participant is asked to repeat a series of digits in reverse order. The maximum raw score is 16, with higher scores indicating better memory.
Proportion of fallers
Number of fallers from participants at 6 months in each intervention group
Full Information
NCT ID
NCT05725668
First Posted
February 2, 2023
Last Updated
July 5, 2023
Sponsor
Oregon Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05725668
Brief Title
A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment
Official Title
Dual-Task Training Exercise to Reduce Falls in Older Adults With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
January 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.
Detailed Description
The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Accidental Falls, Aging
Keywords
Falls, Exercise, Dual tasking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual-task taj ji quan
Arm Type
Experimental
Arm Description
This intervention includes training of (a) symmetrical postural tai ji quan forms/movements synchronized with breathing, (b) controlled displacement (weight-shifting) of the body's center of mass over the base of support, (c) dynamic eye-hand movements during whole-body motion, (d) multidirectional (anterior-posterior and medial-lateral) stepping, and (e) rotational ankle sway and self-induced reactive postural recovery actions. The training practices are integrated, gradually over time, with a mix of interactive, cognitively stimulating, dual-task exercises that challenge attention control, working memory, verbalization, response inhibition, processing speed, dual tasking, task switching/prioritization, and spatial orientation and postural awareness.
Arm Title
Standard tai ji quan
Arm Type
Experimental
Arm Description
This intervention includes training of tai ji quan forms with synchronized breathing, supplemented by a set of mini-therapeutic exercises. The training involves repeated practice of (a) symmetrical, coordinated, trunk-driven tai ji quan form movements, (b) controlled displacement (weight-shifting) of the body's center of mass over varying sizes of the base of support, (c) dynamic eye-hand movements during whole-body motion, and (d) multidirectional (anterior-posterior and medial-lateral) stepping. As a balance training therapy, movement practices emphasize a dynamic interplay of stabilizing and self-induced destabilizing postural actions and balance exercises that target mobility, stability limits, and sensory integration.
Arm Title
Stretching exercise
Arm Type
Experimental
Arm Description
This active control intervention includes light activities that consist of breathing, stretching, and relaxation exercises. Each exercise session encompasses a variety of light and static stretches for joints and muscles, performed in a seated or standing position. Exercise involves the upper body (arms, neck, upper back, shoulder, back, and chest), lower extremities (quadriceps, hamstrings/calfs, and hips), and gentle and slow trunk rotations. Also included are intermittent light walking, deep abdominal breathing exercises that emphasize inhaling and exhaling to maximum capacity, and progressive relaxation of major muscle groups.
Intervention Type
Behavioral
Intervention Name(s)
dual-task tai ji quan
Intervention Description
dual-task tai ji quan training
Intervention Type
Behavioral
Intervention Name(s)
standard tai ji quan
Intervention Description
standard tai ji quan training
Intervention Type
Behavioral
Intervention Name(s)
stretching
Intervention Description
stretching exercise
Primary Outcome Measure Information:
Title
Self-reported number of falls
Description
This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors
Time Frame
Monthly, baseline to 6 months (i.e., after end of intervention)
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
Reflects change in lower extremity function with intervention. This is measured by Short Physical Performance Battery which involves three functional tasks: static balance, gait speed, and getting in and out of a chair, with scores ranging from 0 (worst performance) to 12 (best performance).
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Timed Up and Go (TUG)
Description
Reflects change in lower extremity physical function with intervention. This is measured by the Timed Up and Go test (TUG; in seconds) which assesses mobility and fall risk. The test measures the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower scores represent better lower extremity physical function.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Dual-task walking
Description
Reflects change in dual-task costs in gait speed with intervention. The TUG test protocol will be repeated under a dual-task condition where the participant is asked to walk while performing an arithmetic task (i.e., starting at the number 81 and sequentially subtracting 5 from the resulting number). Lower scores on this walk indicate better performance. Dual-task walking cost is defined as the difference between single- and dual-task walking speed, expressed in percentage, with less negative values representing improvement in dual-task walking speed relative to single-task walking.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
30-second chair stand
Description
Reflects change in lower extremity strength and endurance with intervention. This is measured by the 30-second chair stand test. The test is conducted by asking the participant to stand up from a chair and sit down fully and to perform as many cycles of sit-to-stand-to-sit as possible in 30 seconds. Higher scores (number of stands) represent higher levels of strength and endurance.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Montreal Cognitive Assessment (MoCA)
Description
Reflects change in global cognitive function. This is measured by MoCA which measures cognitive function of multiple domains (attention/concentration, executive functions, short term memory, language, visuospatial abilities, orientation to time and place). MoCA has a total score that ranges from 0 to 30, with higher scores representing better cognitive functioning.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Trail Making (A, B)
Description
Reflects change in executive function with intervention. This is measured by Trail Making Test (TMT) which consists of two parts (A and B). In Part A, the participant is asked to count the number (1 through 25) off the screen out loud as quickly as possible. In Part B, the participant is asked to recite numbers and letters in an alternating sequence (1-A-2-B-3-C . . . 12-L) as quickly as possible. Errors are corrected immediate with the clock running. For Parts A and B, scoring is expressed in terms of the time (in seconds) to completion. The difference in time taken to complete Part B versus Part A is calculated to form a measure of executive function, with smaller difference scores indicating better executive function.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Category Fluency
Description
Reflects change in memory with intervention. This is measured by a category fluency test in which the participant is asked to generate the names of as many animals as possible in 60 seconds.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Forward Digit Span
Description
Reflects change in attention with intervention. This is measured by Forward Digit Span test. During the test, the participant is asked to repeat a series of digits in the order given. The maximum raw score is 16, with higher scores indicating better attention.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Backward Digit Span
Description
Reflects change in short-term working memory with intervention. This is measured by Backward Digit Span test. During the test, the participant is asked to repeat a series of digits in reverse order. The maximum raw score is 16, with higher scores indicating better memory.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Proportion of fallers
Description
Number of fallers from participants at 6 months in each intervention group
Time Frame
At 6 months
Other Pre-specified Outcome Measures:
Title
Activity-specific Balance Confidence
Description
Reflects change in the perceptions of balance with intervention. This is measured by the Activity-specific Balance Confidence Scale which assesses one's confidence in performing various activities of daily living without compromising one's balance. It includes such items as picking up an object from the floor, standing on a chair to reach, and walking on icy sidewalks. The scale contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Pittsburgh Sleep Quality Index
Description
Reflects change in quality of sleep with intervention. This is measured by the Pittsburgh Sleep Quality Index which includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleep medication, and daytime dysfunction (e.g., having difficulty staying awake during the day). Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Geriatric Depression Scale
Description
Reflects change in the level of depression with intervention. This is measured by the Geriatric Depression Scale (GDS). The 15-item version of the GDS will be used with the scores ranging from 0 to 15. A score of 0 to 4 is considered to be within the normal range, 5 to 9 indicates mild depression, and a score of 10 or more indicates moderate to severe depression.
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
EuroQol EQ-5D
Description
Reflects change in quality of life with intervention. This is measured by EuroQol EQ-5D which assesses health status in five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is measured at three levels: no problems (coded as 1), some problems (2), and extreme problems (3). An EQ-5D utility score will be calculated for each participant based on the U.S. population-based (preference-weighted) health index scores on a scale ranging from less than 0 (worst health state) to 1.0 (best or perfect health state).
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
Frailty Questionnaire
Description
Reflects change in frailty with intervention. Frailty is measured by the Frailty Questionnaire which assesses 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of Weight. The scale scores range from 0 to 5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
Time Frame
Baseline, 4 months, 6 months, 12 months
Title
International Physical Activity Questionnaire
Description
Reflects change in physical activity with intervention. Total weekly minutes spent in vigorous physical activity (PA) and moderate PA will be measured. Two self-report PA measures will be calculated: total weekly minutes of vigorous + moderate PA in bouts of ≥10 min, excluding walking (MVPA) and total weekly minutes of walking in bouts of ≥10 min (Walk). We will report Total PA (MVPA + Walk), which is conceptually the same construct as accelerometry MVPA in ≥10 min bouts.
Time Frame
Baseline, 4 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
being 65 years and older
having complaint of memory loss
scoring ≤0.5 on Clinical Dementia Scale
having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test
Exclusion Criteria:
scoring <24 on the Mini-Mental State Examination
being able to ambulate independently for household distances
having medical clearance
having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
being unwilling to be randomized
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuzhong Li, Ph.D.
Phone
541-484-2123
Email
fuzhongl@ori.org
Facility Information:
Facility Name
Oregon Research Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuzhong Li, Ph.D.
Phone
541-484-2123
Ext
2137
Email
fuzhongl@ori.org
First Name & Middle Initial & Last Name & Degree
Fuzhong Li, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The following data will be made available with publication: deidentified participant data and data directory. Additional data that have not been published will be withheld until at least 6 months after publication. Data will be made available as required for specific, approved analyses and will be provided from a locked, cleaned, and deidentified database. Requests will be reviewed the principal investigator before approval. Before any analysis, a signed confidentiality agreement or data sharing agreement is required.
IPD Sharing Time Frame
6 months after the study results are published in a peer-reviewed journal and the data sharing plan will end 12 months after the publication.
IPD Sharing Access Criteria
We will share all data that support published results of the trial.
Learn more about this trial
A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment
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