Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease

NCT ID: NCT04842734

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2021-12-25

Brief Summary

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Our aim has been determined to investigate the effect of physical exercise alone and in combination with cognitive exercise, on cognitive, physical function and quality of life in individuals with Alzheimer's Disease during the Covid-19 pandemic period.

Detailed Description

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Conditions

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Alzheimer Disease Telerehabilitation Online Physical Exercise Computerized Cognitive Stimulation Covid-19 Pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is planned to include 60 individuals diagnosed with AD according to DSM-IV diagnostic criteria by the neurologist. Individuals will be randomly divided into three groups; as the physical exercise group (n=20), physical exercise and cognitive stimulation (n=20) and the control group (n=20) according to inclusion criteria
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Physical exercise and computerized cognitive stimulation

Supervised Physical Exercise Program (SPEP) sessions will be performed simultaneously online together with the physiotherapist and the patient. Participants will be able to do the exercises together with their caregivers if needed.

The Computerized Cognitive Stimulation Program (CCSP) (Beynex) will be planned for 12 weeks, 5 days a week, approximately 10 minutes, for a total of 40 sessions.

Fisrtly, the use of CCSP will be demonstrated to the patients. Then, it will be given as home program. While the patients play the games in CCSP via their smartphones, their caregivers will be informed in detail about accompanying the patients if they need it. The follow-up of cognitive stimulation will be made with the person accompanying the patient over the phone.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

Group Type EXPERIMENTAL

Physical exercise and computerized cognitive training

Intervention Type OTHER

SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour. The CCSP is planned for 12 weeks, minimum 3 to maximum 5 days a week, approximately 10 minutes, for a total of 36-60 sessions

physical exercise

SPEP sessions will be demonstrated to individuals by a 6-year-experienced physiotherapist via videoconference (Zoom Inc.) and the exercises will be performed simultaneously online together with the physiotherapist and the patient. Participants will be able to do the exercises together with their caregivers if needed.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

Group Type EXPERIMENTAL

Physical exercise

Intervention Type OTHER

SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour

control

The individuals included in this group will be informed that they should continue their normal daily life activities.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical exercise

SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour

Intervention Type OTHER

Physical exercise and computerized cognitive training

SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour. The CCSP is planned for 12 weeks, minimum 3 to maximum 5 days a week, approximately 10 minutes, for a total of 36-60 sessions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 65 years and older
* Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist,
* MOCA ≥ 13
* Clinical Dementia Rating Scale \< 2
* Having sufficient wireless support or telephone connection where the person lives
* Who gave consent to participate in the study
* No history of any neurological or orthopedic injury that could prevent participation in the study and affect functional mobility.

Exclusion Criteria

* Geriatric Depression Scale score \> 11
* Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.)
* Clinically significant aphasia (must be able to understand the therapist's commands)
* Significant visual or sensory impairment
* MoCA \< 13
* Having a severe musculoskeletal disorder
* Having paralysis
* Impaired balance
* The presence of severe lung and heart disease
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Akbuğa Koç

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeditepe University

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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25.03.2021/37

Identifier Type: -

Identifier Source: org_study_id

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