search
Back to results

Imagery in Early Stages of Dementia

Primary Purpose

Mental Imagery, Dementia of Alzheimer Type

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mental imagery (MI) and exercise program
Mental Imagery and Exercise program
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Imagery focused on measuring Imagery, Exercise, Dementia

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 95 years<age>65 years
  • Diagnosed early stage of dementia
  • Good oral and written speech and to perform orders
  • Both sexes
  • Ambulatory
  • No other health issues in the last month

Exclusion Criteria:

  • Late stage of dementia
  • Psychiatric problems
  • Serious health problems
  • Not able to walk

Sites / Locations

  • University of West AtticaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mental imagery (MI) and exercise program

Exercise program

Arm Description

MI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).

The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).

Outcomes

Primary Outcome Measures

Change is being assessed (Change from Baseline Balance at 12 weeks)
The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Change is being assessed (Change from Baseline Stability at 12 weeks)
The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.
Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)
The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.
Change is being assessed (Change from Baseline Functional status at 12 weeks)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

Secondary Outcome Measures

Cognitive ability
The Walking While Talking Test (WWITT) is a dual-task measure to examine cognitive-motor interactions. During the WWTT, subjects walk at self-paced speed for 6 meters before turning and walking back to the starting point. During the walking subjects recite 12 Greek alphabet letters (each letter at each step) starting with "A" (ΑΒΓΔ, ΚΛΜΝ, ΠΡΣΤ) until the starting point. Time and errors in the alphabet will be recorded.
Depression
The Short-Form of Geriatric Depression Scale (SF-GDS) is a 15-question screening tool for depression in older adults, using a "Yes/No" format. It takes 5-7 minutes to complete and is filled out by the researcher with minimal training in its use.
Quality of life
The Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale) is a preference-based Health Related Quality of Life measure which includes 5 domains, i.e., mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The core of all domains ranges from 1 (best score) up to 5 (worse score). The total perceived quality of life will be graded by the patient. Also it includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Full Information

First Posted
January 13, 2022
Last Updated
January 31, 2022
Sponsor
University of West Attica
Collaborators
Alzheimer's Association
search

1. Study Identification

Unique Protocol Identification Number
NCT05232526
Brief Title
Imagery in Early Stages of Dementia
Official Title
The Effectiveness of Mental Imagery in Motor and Cognitive Rehabilitation in Subjects of Early Stage of Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
October 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica
Collaborators
Alzheimer's Association

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population.
Detailed Description
Dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). The most common form of dementia in older adults is Alzheimer disease (AD), accounting for 60 to 80 percent of cases. Mental imagery (MI) is a technique which involves envisioning motor actions without actual execution. MI is considered an effective rehabilitative tool in athletes, Parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference. The recruitment of the population will be carried out by Day Care Centers in Athens Alzheimer Association. A group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. Information sheet and consent form will be provided to all participants. A randomized intervention study is designed to assess the efficacy of MI as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. MI and exercise program (intervention group) 2. Only exercise program (control group) 3. Neither MI nor exercise program (2nd control group). Assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Imagery, Dementia of Alzheimer Type
Keywords
Imagery, Exercise, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental imagery (MI) and exercise program
Arm Type
Experimental
Arm Description
MI will start immediately when the sample is going to start the exercise program. The intervention group will undergo 24 sessions of imagery, starting from the 1st exercise program session. Participants of the intervention group will undergo a 45-minute imagery session sitting in a quiet place after the end of every exercise program session. The content of every imagery session is alike with the content of the exercise program session. That means that every session includes imagery of the same exercises of the exercise program performed earlier by the subject in the Day Center. Sessions are identical for all subjects of the intervention group. The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).
Arm Title
Exercise program
Arm Type
Placebo Comparator
Arm Description
The total duration of the physiotherapy exercise program will be 24 sessions, 2 times/week, duration of 45 minutes each session, 3 months (12 weeks).
Intervention Type
Other
Intervention Name(s)
Mental imagery (MI) and exercise program
Intervention Description
Mental imagery and exercise program will be used to improve balance, functional status, cognitive ability, depression and quality of life of the sample
Intervention Type
Device
Intervention Name(s)
Mental Imagery and Exercise program
Intervention Description
Questionnaires and functional tests are going to be used to evaluate balance, functional status, cognitive ability, depression and quality of life of the sample.
Primary Outcome Measure Information:
Title
Change is being assessed (Change from Baseline Balance at 12 weeks)
Description
The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Time Frame
Prior to the 1st week of the program, the 12th week of the program
Title
Change is being assessed (Change from Baseline Stability at 12 weeks)
Description
The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.
Time Frame
Prior to the 1st week of the program, the 12th week of the program
Title
Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)
Description
The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.
Time Frame
Prior to the 1st week of the program, the 12th week of the program
Title
Change is being assessed (Change from Baseline Functional status at 12 weeks)
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Time Frame
Prior to the 1st week of the program, the 12th week of the program
Secondary Outcome Measure Information:
Title
Cognitive ability
Description
The Walking While Talking Test (WWITT) is a dual-task measure to examine cognitive-motor interactions. During the WWTT, subjects walk at self-paced speed for 6 meters before turning and walking back to the starting point. During the walking subjects recite 12 Greek alphabet letters (each letter at each step) starting with "A" (ΑΒΓΔ, ΚΛΜΝ, ΠΡΣΤ) until the starting point. Time and errors in the alphabet will be recorded.
Time Frame
Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Title
Depression
Description
The Short-Form of Geriatric Depression Scale (SF-GDS) is a 15-question screening tool for depression in older adults, using a "Yes/No" format. It takes 5-7 minutes to complete and is filled out by the researcher with minimal training in its use.
Time Frame
Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program
Title
Quality of life
Description
The Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale) is a preference-based Health Related Quality of Life measure which includes 5 domains, i.e., mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The core of all domains ranges from 1 (best score) up to 5 (worse score). The total perceived quality of life will be graded by the patient. Also it includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame
Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 95 years<age>65 years Diagnosed early stage of dementia Good oral and written speech and to perform orders Both sexes Ambulatory No other health issues in the last month Exclusion Criteria: Late stage of dementia Psychiatric problems Serious health problems Not able to walk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Christakou, PhD
Phone
+306977370284
Email
achristakou@uniwa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Vasiliki Sakellari, Pr
Phone
+306979033952
Email
vsakellari@uniwa.gr
Facility Information:
Facility Name
University of West Attica
City
Athens
State/Province
Aigaleo
ZIP/Postal Code
12243
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Christakou, PhD
Phone
+306977370284
Email
achristakou@uniwa.gr
First Name & Middle Initial & Last Name & Degree
Vasiliki Sakellari, Pr
Phone
+306979033952
Email
vsakellari@uniwa.gr
First Name & Middle Initial & Last Name & Degree
Christina Mpouzineki
First Name & Middle Initial & Last Name & Degree
Anna Christakou, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Imagery in Early Stages of Dementia

We'll reach out to this number within 24 hrs