Home-Based Telerehabilitation for People With Alzheimer Disease

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606251
• Other study ID #: Kübra Nur Menengiç, IUC
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: July 2021
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 15, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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".	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks