Back to resultsComparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Telerehabilitation, Online Physical Exercise
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical exercise
Physical exercise and computerized cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Telerehabilitation, Physical exercise, Computerized Cognitive Stimulation, Covid-19 Pandemic, Cognitive Stimulation, Online physical exercise, Alzheimer disease
Eligibility Criteria
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
Sites / Locations
- Yeditepe University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Physical exercise and computerized cognitive stimulation
physical exercise
control
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
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).
Montreal Cognitive Assessment Scale
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Berg Balance Scale
Berg Balance Scale measures static and dynamic balance in elderly individuals.
Time up and Go Test
TUG test evaluates fall risk, mobility and physical performance in the elderly
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
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
Secondary Outcome Measures
Katz Activities of Daily Living Scale
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
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)
The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04842734
Brief Title
Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease
Official Title
Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease During the Covid-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
July 23, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical exercise and computerized cognitive stimulation
Arm Type
Experimental
Arm Description
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).
Arm Title
physical exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour
Intervention Type
Other
Intervention Name(s)
Physical exercise and computerized cognitive training
Intervention Description
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
Primary Outcome Measure Information:
Title
Alzheimer's Disease Related Quality of Life Scale
Description
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).
Time Frame
24 weeks
Title
Montreal Cognitive Assessment Scale
Description
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Time Frame
24 weeks
Title
Berg Balance Scale
Description
Berg Balance Scale measures static and dynamic balance in elderly individuals.
Time Frame
24 weeks
Title
Time up and Go Test
Description
TUG test evaluates fall risk, mobility and physical performance in the elderly
Time Frame
24 weeks
Title
Sit to Stand Test
Description
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
Time Frame
24 weeks
Title
Arm Curl Test
Description
The Arm Curl test is one of the subtests of the Senior fitness test and it is performed to evaluate upper extremity muscle strength
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Katz Activities of Daily Living Scale
Description
Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities.
Time Frame
24 weeks
Title
Lawton Instrumental Activities of Daily Living Scale
Description
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
Time Frame
24 weeks
Title
Geriatric Depression Scale (Short Form)
Description
The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yeditepe University
City
İstanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34865
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease
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