Back to resultsHome-Based Telerehabilitation for People With Alzheimer Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Exercise Training, Cognition, Telemedicine, Telehealth
Eligibility Criteria
Inclusion Criteria:
- Over 65 years old,
- Diagnosed with Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
- Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
- Mini Mental Test score between 13-24 points,
- The caregiver living with is sufficient in the use of technology,
- Cases who could understand the instructions given in Turkish were included in the study.
Exclusion Criteria:
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Modified Charlson Comorbidity Index score greater than 6,
- Receiving any rehabilitation service from an institution or person,
- Having regular exercise habits,
- Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm 1: Exercise Group
Arm 2: Control Group
Arm Description
This group will consist of the subjects taken for 6 weeks of exercise.
This group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks.
Outcomes
Primary Outcome Measures
Cognitive Function-Mini Mental Test
Mini Mental Test evaluates the cognitive skills. For each question of the test, the correct answer is scored as 1 point, the incorrect answer 0 point. Test is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon; the maximum score is 9.
Timed Up and Go Test
Timed Up and Go Test measure the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
Physical Mobility-5 Time Sit to Stand Test
5 Time Sit to Stand Test measure the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
Secondary Outcome Measures
Balance-One Leg Stance Test
One Leg Stance Test evaluates the static balance. The time of standing unsupported on one leg with eyes open, hands beside the body is recorded. The test is finished when the patient's foot touches the ground. Longer duration indicates good balance.
Activities of Daily Living-Katz Activities of Daily Living Scale
Katz Activities of Daily Living Scale is a questionnaire that measures the ability of people to perform daily activities functionally. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Depression-Geriatric Depression Scale
The Geriatric Depression Scale is a 30-item self-report measure designed to assess and screen depressive symptoms among older adults. Each item on the GDS is scored with one point for a depressive response. Items are summed to determine the total score with a maximum of 30 points. General interpretive guidelines are as follows: scores ranging from 0 to 9 indicate normal mood, scores of 10 to 19 indicate mild depressive symptoms, and scores of 20 to 30 indicate severe depressive symptoms.
Anxiety-Beck Anxiety Inventory
The beck anxiety scale is a questionnaire used to measure the anxiety levels of individuals. Respondents are asked to report the extent to which they have been bothered by each of the 21 symptoms in the week preceding their completion of the Beck Anxiety Inventory. Each symptom item has four possible answer choices: Not at All (0 point); Mildly (1 point), Moderately (2 point), and; Severely (3 point). A total score of 0-7 is interpreted as a "Minimal" level of anxiety; 8-15 as "Mild"; 16-25 as "Moderate", and; 26-63 as "Severe".
Burden-Zarit Burden Scale
The Zarit Burden Scale is a questionnaire that measures the care burden of caregivers. It contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores indicate greater burden.
Well-being-Warwick Edinburgh Mental Well-being Scale
Warwick-Edinburgh Mental Well-being Scale measures parameters such as coping with stress, being productive and beneficial. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The total score is obtained by summing the score for each of the 14 items. The minimum scale score is 14 and the maximum is 70. Higher scores are associated with higher levels of mental well-being.
Full Information
NCT ID
NCT04606251
First Posted
October 24, 2020
Last Updated
July 16, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04606251
Brief Title
Home-Based Telerehabilitation for People With Alzheimer Disease
Official Title
Home-Based Telerehabilitation for People With Alzheimer Disease: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
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 aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in Alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. Secondary aim is to examine the effect of the exercise application on the care burden and well-being of caregivers.
Detailed Description
Exercise application in the study will take 6 weeks. Evaluations will be made twice, at the beginning and end of the exercise application.
Functional mobility was measured with the 5-Times Sit-and-Stand Test (5XSTS) and Timed Up and Go Test (TUG); static balance with One-Leg Stand Test; functional independence level with Functional Independence Scale (FIM); daily living activities will be evaluated with the Katz Activities of Daily Living Scale.
The general cognitive level of the cases was determined by Mini-Mental State Examination; Depressive symptoms will be measured with the Geriatric Depression Scale-Short Form, and anxiety levels will be measured with the Beck Anxiety Scale.
The care burden of caregivers will be assessed with the Zarit Care Burden Scale, and caregiver's well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale.
Primary outcome measures are Mini Mental Test, Timed Up&Go Test, and the 5-Times Sit-and-Stand Test .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Exercise Training, Cognition, Telemedicine, Telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Controlled Research Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Exercise Group
Arm Type
Experimental
Arm Description
This group will consist of the subjects taken for 6 weeks of exercise.
Arm Title
Arm 2: Control Group
Arm Type
No Intervention
Arm Description
This group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The intervention to be carried out in the study consists of physical exercises for the neck, upper and lower extremities, and trunk; It is a program that includes the addition of cognitive tasks such as memory, word finding, processing during each repetition.
Primary Outcome Measure Information:
Title
Cognitive Function-Mini Mental Test
Description
Mini Mental Test evaluates the cognitive skills. For each question of the test, the correct answer is scored as 1 point, the incorrect answer 0 point. Test is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon; the maximum score is 9.
Time Frame
6 weeks
Title
Timed Up and Go Test
Description
Timed Up and Go Test measure the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
Time Frame
6 weeks
Title
Physical Mobility-5 Time Sit to Stand Test
Description
5 Time Sit to Stand Test measure the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Balance-One Leg Stance Test
Description
One Leg Stance Test evaluates the static balance. The time of standing unsupported on one leg with eyes open, hands beside the body is recorded. The test is finished when the patient's foot touches the ground. Longer duration indicates good balance.
Time Frame
6 weeks
Title
Activities of Daily Living-Katz Activities of Daily Living Scale
Description
Katz Activities of Daily Living Scale is a questionnaire that measures the ability of people to perform daily activities functionally. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Time Frame
6 weeks
Title
Depression-Geriatric Depression Scale
Description
The Geriatric Depression Scale is a 30-item self-report measure designed to assess and screen depressive symptoms among older adults. Each item on the GDS is scored with one point for a depressive response. Items are summed to determine the total score with a maximum of 30 points. General interpretive guidelines are as follows: scores ranging from 0 to 9 indicate normal mood, scores of 10 to 19 indicate mild depressive symptoms, and scores of 20 to 30 indicate severe depressive symptoms.
Time Frame
6 weeks
Title
Anxiety-Beck Anxiety Inventory
Description
The beck anxiety scale is a questionnaire used to measure the anxiety levels of individuals. Respondents are asked to report the extent to which they have been bothered by each of the 21 symptoms in the week preceding their completion of the Beck Anxiety Inventory. Each symptom item has four possible answer choices: Not at All (0 point); Mildly (1 point), Moderately (2 point), and; Severely (3 point). A total score of 0-7 is interpreted as a "Minimal" level of anxiety; 8-15 as "Mild"; 16-25 as "Moderate", and; 26-63 as "Severe".
Time Frame
6 weeks
Title
Burden-Zarit Burden Scale
Description
The Zarit Burden Scale is a questionnaire that measures the care burden of caregivers. It contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores indicate greater burden.
Time Frame
6 weeks
Title
Well-being-Warwick Edinburgh Mental Well-being Scale
Description
Warwick-Edinburgh Mental Well-being Scale measures parameters such as coping with stress, being productive and beneficial. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The total score is obtained by summing the score for each of the 14 items. The minimum scale score is 14 and the maximum is 70. Higher scores are associated with higher levels of mental well-being.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 65 years old,
Diagnosed with Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
Mini Mental Test score between 13-24 points,
The caregiver living with is sufficient in the use of technology,
Cases who could understand the instructions given in Turkish were included in the study.
Exclusion Criteria:
Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
Modified Charlson Comorbidity Index score greater than 6,
Receiving any rehabilitation service from an institution or person,
Having regular exercise habits,
Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34971285
Citation
Menengic KN, Yeldan I, Cinar N, Sahiner TA. Effectiveness of home-based telerehabilitation in mild to moderate Alzheimer's disease: A randomised controlled study. Alzheimers Dement. 2021 Dec;17 Suppl 8:e053406. doi: 10.1002/alz.053406.
Results Reference
derived
Learn more about this trial
Home-Based Telerehabilitation for People With Alzheimer Disease
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