Home-Based Telerehabilitation for People With Alzheimer Disease
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Oct 2020
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2021
CompletedJuly 22, 2021
July 1, 2021
21 days
October 24, 2020
July 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
6 weeks
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.
6 weeks
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.
6 weeks
Secondary Outcomes (6)
Balance-One Leg Stance Test
6 weeks
Activities of Daily Living-Katz Activities of Daily Living Scale
6 weeks
Depression-Geriatric Depression Scale
6 weeks
Anxiety-Beck Anxiety Inventory
6 weeks
Burden-Zarit Burden Scale
6 weeks
- +1 more secondary outcomes
Study Arms (2)
Arm 1: Exercise Group
EXPERIMENTALThis group will consist of the subjects taken for 6 weeks of exercise.
Arm 2: Control Group
NO INTERVENTIONThis group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 34971285DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 24, 2020
First Posted
October 28, 2020
Study Start
October 30, 2020
Primary Completion
November 20, 2020
Study Completion
April 15, 2021
Last Updated
July 22, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share