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

NCT04842734 | Completed

• 1 other identifier: 25.03.2021/37
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alzheimer's disease; Telerehabilitation; Physical exercise; Computerized Cognitive Stimulation; Covid-19 Pandemic; Cognitive Stimulation; Online physical exercise; Alzheimer disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Katz Activities of Daily Living Scale

  24 weeks

• Lawton Instrumental Activities of Daily Living Scale

  24 weeks

• Geriatric Depression Scale (Short Form)

  24 weeks

Study Arms (3)

Physical exercise and computerized cognitive stimulation

EXPERIMENTAL

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

physical exercise

EXPERIMENTAL

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

control

NO INTERVENTION

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).

Interventions

Physical exercise OTHER

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

physical exercise

Physical exercise and computerized cognitive training 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 and computerized cognitive stimulation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Istanbul, Eyalet/Yerleşke, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease; COVID-19; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 13, 2021
• Study Start: April 27, 2021
• Primary Completion: July 23, 2021
• Study Completion: December 25, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

TU (1)