Home-Based Telerehabilitation for People With Alzheimer Disease

NCT ID: NCT04606251

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-04-15

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 .

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Exercise Group

This group will consist of the subjects taken for 6 weeks of exercise.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Arm 2: Control Group

This group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Kübra Nur Menengiç

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 34971285 (View on PubMed)

Other Identifiers

Kübra Nur Menengiç, IUC

Identifier Type: -

Identifier Source: org_study_id