Clinical trial NCT04606251: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Exercise Training
Cognition
Telemedicine
Telehealth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled Research Study
Primary purpose: TREATMENT

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 .

Eligibility criteria: Inclusion Criteria:

1. Over 65 years old,
2. 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,
3. Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
4. Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
5. Mini Mental Test score between 13-24 points,
6. The caregiver living with is sufficient in the use of technology,
7. Cases who could understand the instructions given in Turkish were included in the study.

Exclusion Criteria:

1. Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
2. Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
3. Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
4. Modified Charlson Comorbidity Index score greater than 6,
5. Receiving any rehabilitation service from an institution or person,
6. Having regular exercise habits,
7. Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.

Primary outcomes:
measure: Cognitive Function-Mini Mental Test
timeFrame: 6 weeks
measure: Timed Up and Go Test
timeFrame: 6 weeks
measure: Physical Mobility-5 Time Sit to Stand Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Balance-One Leg Stance Test
timeFrame: 6 weeks
measure: Activities of Daily Living-Katz Activities of Daily Living Scale
timeFrame: 6 weeks
measure: Depression-Geriatric Depression Scale
timeFrame: 6 weeks
measure: Anxiety-Beck Anxiety Inventory
timeFrame: 6 weeks
measure: Burden-Zarit Burden Scale
timeFrame: 6 weeks
measure: Well-being-Warwick Edinburgh Mental Well-being Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
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.