Alzheimer DiseaseNCT04842734
Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease
A study testing Physical exercise and Physical exercise and computerized cognitive training in people with Alzheimer Disease and Telerehabilitation, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Telerehabilitation, Online Physical Exercise
- What is being tested?
- Physical exercise and Physical exercise and computerized cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2021to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Show all 9Show fewer
- Having paralysis
- Impaired balance
- The presence of severe lung and heart disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University
Istanbul, Eyalet/Yerleşke, 34865
About this study
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
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
- Being tested
- Physical exercise, Physical exercise and computerized cognitive training
- Keywords
- Alzheimer's disease, Telerehabilitation, Physical exercise, Computerized Cognitive Stimulation, Covid-19 Pandemic, Cognitive Stimulation, Online physical exercise, Alzheimer disease
- Medical subject headings
- Alzheimer Disease, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour
Physical exercise and computerized cognitive trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Montreal Cognitive Assessment Scale
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Measured: 24 weeks
Berg Balance Scale
Berg Balance Scale measures static and dynamic balance in elderly individuals.
Measured: 24 weeks
Time up and Go Test
TUG test evaluates fall risk, mobility and physical performance in the elderly
Measured: 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
Measured: 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
Measured: 24 weeks
Secondary outcomes (3)
Katz Activities of Daily Living Scale
Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities.
Measured: 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
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start27 Apr 2021
- Primary completion23 Jul 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Akbuğa Koç, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842734
- Sponsor's protocol ID
- 25.03.2021/37
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04842734
- Acronym / sponsor ID
- 25.03.2021/37
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Physical exercise and computerized cognitive stimulation | Experimental | Other: Physical exercise and computerized cognitive trainingSupervised 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 | Experimental | Other: Physical exerciseSPEP 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). |
| 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseSPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour | Other | physical exercise |
| Physical exercise and computerized cognitive trainingSPEP 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 | Other | Physical exercise and computerized cognitive stimulation |
Primary outcome
Alzheimer's Disease Related Quality of Life Scale
Time frame: 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).
Montreal Cognitive Assessment Scale
Time frame: 24 weeks
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Berg Balance Scale
Time frame: 24 weeks
Berg Balance Scale measures static and dynamic balance in elderly individuals.
Time up and Go Test
Time frame: 24 weeks
TUG test evaluates fall risk, mobility and physical performance in the elderly
Sit to Stand Test
Time frame: 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
Arm Curl Test
Time frame: 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
3 secondary outcomes
Katz Activities of Daily Living Scale
Time frame: 24 weeks
Lawton Instrumental Activities of Daily Living Scale
Time frame: 24 weeks
Geriatric Depression Scale (Short Form)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Physical exercise and computerized cognitive training in people with Alzheimer Disease and Telerehabilitation, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Related Quality of Life Scale (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.