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

Not Applicable

Completed

• Conditions: Telerehabilitation; Computerized Cognitive Stimulation; Online Physical Exercise; Covid-19 Pandemic; Alzheimer Disease
• Interventions: Other: Physical exercise and computerized cognitive training; Other: Physical exercise

• Registration Number: NCT04842734
• Lead Sponsor: Yeditepe University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-13
• Study Start: 2021-04-27
• Primary Completion: 2021-07-23
• Study Completion: 2021-12-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical exercise and computerized cognitive stimulation	Physical exercise and computerized cognitive training	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).
physical exercise	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).

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment Scale	24 weeks	MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Alzheimer's Disease Related Quality of Life Scale	24 weeks	This scale evaluates health-related quality of life in individuals with AD. The scale includes 40 questions in total and examines 5 quality of life domains (A-Social Interaction, B-Self Awareness, C-Affect and Mood, D- Enjoying Activities, E-Interaction with the Environment).
Arm Curl Test	24 weeks	The Arm Curl test is one of the subtests of the Senior fitness test and it is performed to evaluate upper extremity muscle strength
Berg Balance Scale	24 weeks	Berg Balance Scale measures static and dynamic balance in elderly individuals.
Time up and Go Test	24 weeks	TUG test evaluates fall risk, mobility and physical performance in the elderly
Sit to Stand Test	24 weeks	Sit-to-stand test will be performed on an armless chair with a height of 46 cm to determine the physical fitness level of elderly individuals

Secondary Outcome Measures

Name	Time	Method
Katz Activities of Daily Living Scale	24 weeks	Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities.
Lawton Instrumental Activities of Daily Living Scale	24 weeks	Lawton IADL scale consists of 8 items and a single subscale. In addition, it consists of eight questions about using the phone, preparing meals, shopping, doing daily household chores, washing clothes, getting on the transportation vehicle, taking medicines and money management
Geriatric Depression Scale (Short Form)	24 weeks	The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals

Trial Locations

Locations (1)

Yeditepe University; 🇹🇷 İstanbul, Eyalet/Yerleşke, Turkey