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

Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease During the Covid-19 Pandemic

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Telerehabilitation; Covid-19 Pandemic; Online Physical Exercise; Computerized Cognitive Stimulation
• Intervention / Treatment: Other: Physical exercise and computerized cognitive training; Other: Physical exercise

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyalet/Yerleşke
    • İstanbul, Eyalet/Yerleşke, Turkey, 34865
      • Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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
Experimental: 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).	Other: Physical exercise; SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Related Quality of Life Scale	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).	24 weeks
Montreal Cognitive Assessment Scale	MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.	24 weeks
Berg Balance Scale	Berg Balance Scale measures static and dynamic balance in elderly individuals.	24 weeks
Time up and Go Test	TUG test evaluates fall risk, mobility and physical performance in the elderly	24 weeks
Sit to Stand Test	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	24 weeks
Arm Curl Test	The Arm Curl test is one of the subtests of the Senior fitness test and it is performed to evaluate upper extremity muscle strength	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz Activities of Daily Living Scale	Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities.	24 weeks
Lawton Instrumental Activities of Daily Living Scale	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	24 weeks
Geriatric Depression Scale (Short Form)	The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals	24 weeks

Collaborators and Investigators

• Sponsor: Yeditepe University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): July 23, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Telerehabilitation; Physical exercise; Alzheimer disease; Cognitive Stimulation; Computerized Cognitive Stimulation; Covid-19 Pandemic; Online physical exercise
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; COVID-19; Alzheimer Disease
• Other Study ID Numbers: 25.03.2021/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No