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Clinical Trials/NCT04606251
NCT04606251
Completed
Not Applicable

Home-Based Telerehabilitation for People With Alzheimer Disease: A Randomized Controlled Study

Istanbul University - Cerrahpasa (IUC)1 site in 1 country34 target enrollmentOctober 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
34
Locations
1
Primary Endpoint
Cognitive Function-Mini Mental Test
Status
Completed
Last Updated
4 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
October 30, 2020
End Date
April 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Kübra Nur Menengiç

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

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.

Outcomes

Primary Outcomes

Cognitive Function-Mini Mental Test

Time Frame: 6 weeks

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.

Physical Mobility-5 Time Sit to Stand Test

Time Frame: 6 weeks

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.

Timed Up and Go Test

Time Frame: 6 weeks

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.

Secondary Outcomes

  • Depression-Geriatric Depression Scale(6 weeks)
  • Well-being-Warwick Edinburgh Mental Well-being Scale(6 weeks)
  • Balance-One Leg Stance Test(6 weeks)
  • Activities of Daily Living-Katz Activities of Daily Living Scale(6 weeks)
  • Anxiety-Beck Anxiety Inventory(6 weeks)
  • Burden-Zarit Burden Scale(6 weeks)

Study Sites (1)

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