NCT04606251

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

21 days

First QC Date

October 24, 2020

Last Update Submit

July 16, 2021

Conditions

Keywords

Exercise TrainingCognitionTelemedicineTelehealth

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

EXPERIMENTAL

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

Other: Exercise

Arm 2: Control Group

NO INTERVENTION

This 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.

Arm 1: Exercise Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controlled Research Study
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

Locations