Alzheimer DiseaseNCT04606251
Home-Based Telerehabilitation for People With Alzheimer Disease
A study testing Exercise in people with Alzheimer Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in Alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 15 Apr 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
- Over 65 years old,
- Diagnosed with Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
- Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
- Mini Mental Test score between 13-24 points,
- The caregiver living with is sufficient in the use of technology,
- Cases who could understand the instructions given in Turkish were included in the study.
Who cannot join
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Modified Charlson Comorbidity Index score greater than 6,
- Receiving any rehabilitation service from an institution or person,
- Having regular exercise habits,
- Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-Based Telerehabilitation for People With Alzheimer Disease: A Randomized Controlled Study
The aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in Alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. Secondary aim is to examine the effect of the exercise application on the care burden and well-being of caregivers.
Read the detailed description
Exercise application in the study will take 6 weeks. Evaluations will be made twice, at the beginning and end of the exercise application.
Functional mobility was measured with the 5-Times Sit-and-Stand Test (5XSTS) and Timed Up and Go Test (TUG); static balance with One-Leg Stand Test; functional independence level with Functional Independence Scale (FIM); daily living activities will be evaluated with the Katz Activities of Daily Living Scale.
The general cognitive level of the cases was determined by Mini-Mental State Examination; Depressive symptoms will be measured with the Geriatric Depression Scale-Short Form, and anxiety levels will be measured with the Beck Anxiety Scale.
The care burden of caregivers will be assessed with the Zarit Care Burden Scale, and caregiver's well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale.
Primary outcome measures are Mini Mental Test, Timed Up\&Go Test, and the 5-Times Sit-and-Stand Test .
- Conditions
- Alzheimer Disease
- Being tested
- Exercise
- Keywords
- Exercise Training, Cognition, Telemedicine, Telehealth
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The intervention to be carried out in the study consists of physical exercises for the neck, upper and lower extremities, and trunk; It is a program that includes the addition of cognitive tasks such as memory, word finding, processing during each repetition.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Exercise Group | Experimental | This group will consist of the subjects taken for 6 weeks of exercise. Receives: Other: Exercise |
| Arm 2: Control Group | No intervention | This group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function-Mini Mental Test
Mini Mental Test evaluates the cognitive skills. For each question of the test, the correct answer is scored as 1 point, the incorrect answer 0 point. Test is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon; the maximum score is 9.
Measured: 6 weeks
Timed Up and Go Test
Timed Up and Go Test measure the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
Measured: 6 weeks
Physical Mobility-5 Time Sit to Stand Test
5 Time Sit to Stand Test measure the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
Measured: 6 weeks
Secondary outcomes (6)
Balance-One Leg Stance Test
One Leg Stance Test evaluates the static balance. The time of standing unsupported on one leg with eyes open, hands beside the body is recorded. The test is finished when the patient's foot touches the ground. Longer duration indicates good balance.
Measured: 6 weeks
Activities of Daily Living-Katz Activities of Daily Living Scale
Katz Activities of Daily Living Scale is a questionnaire that measures the ability of people to perform daily activities functionally. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: 6 weeks
Depression-Geriatric Depression Scale
The Geriatric Depression Scale is a 30-item self-report measure designed to assess and screen depressive symptoms among older adults. Each item on the GDS is scored with one point for a depressive response. Items are summed to determine the total score with a maximum of 30 points. General interpretive guidelines are as follows: scores ranging from 0 to 9 indicate normal mood, scores of 10 to 19 indicate mild depressive symptoms, and scores of 20 to 30 indicate severe depressive symptoms.
Measured: 6 weeks
Anxiety-Beck Anxiety Inventory
The beck anxiety scale is a questionnaire used to measure the anxiety levels of individuals. Respondents are asked to report the extent to which they have been bothered by each of the 21 symptoms in the week preceding their completion of the Beck Anxiety Inventory. Each symptom item has four possible answer choices: Not at All (0 point); Mildly (1 point), Moderately (2 point), and; Severely (3 point). A total score of 0-7 is interpreted as a "Minimal" level of anxiety; 8-15 as "Mild"; 16-25 as "Moderate", and; 26-63 as "Severe".
Measured: 6 weeks
Burden-Zarit Burden Scale
The Zarit Burden Scale is a questionnaire that measures the care burden of caregivers. It contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores indicate greater burden.
Measured: 6 weeks
Well-being-Warwick Edinburgh Mental Well-being Scale
Warwick-Edinburgh Mental Well-being Scale measures parameters such as coping with stress, being productive and beneficial. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The total score is obtained by summing the score for each of the 14 items. The minimum scale score is 14 and the maximum is 70. Higher scores are associated with higher levels of mental well-being.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start30 Oct 2020
- Primary completion20 Nov 2020
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Controlled Research Study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Nur Menengiç, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606251
- Sponsor's protocol ID
- Kübra Nur Menengiç, IUC
- Status last verified
- Jul 2021
- First submitted
- 24 Oct 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menengic KN, Yeldan I, Cinar N, Sahiner TA. Effectiveness of home-based telerehabilitation in mild to moderate Alzheimer's disease: A randomised controlled study. Alzheimers Dement. 2021 Dec;17 Suppl 8:e053406. doi: 10.1002/alz.053406.
PubMed 34971285
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Telerehabilitation for People With Alzheimer Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04606251
- Acronym / sponsor ID
- Kübra Nur Menengiç, IUC
- Conditions
- Alzheimer Disease
- Keywords
- Exercise Training, Cognition, Telemedicine, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 28 Oct 2020 (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.
The aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in Alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. Secondary aim is to examine the effect of the exercise application on the care burden and well-being of caregivers.
Detailed description
Exercise application in the study will take 6 weeks. Evaluations will be made twice, at the beginning and end of the exercise application.
Functional mobility was measured with the 5-Times Sit-and-Stand Test (5XSTS) and Timed Up and Go Test (TUG); static balance with One-Leg Stand Test; functional independence level with Functional Independence Scale (FIM); daily living activities will be evaluated with the Katz Activities of Daily Living Scale.
The general cognitive level of the cases was determined by Mini-Mental State Examination; Depressive symptoms will be measured with the Geriatric Depression Scale-Short Form, and anxiety levels will be measured with the Beck Anxiety Scale.
The care burden of caregivers will be assessed with the Zarit Care Burden Scale, and caregiver's well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale.
Primary outcome measures are Mini Mental Test, Timed Up\&Go Test, and the 5-Times Sit-and-Stand Test .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled Research Study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Exercise Group | Experimental | Other: ExerciseThis group will consist of the subjects taken for 6 weeks of exercise. |
| Arm 2: Control Group | No intervention | –This group will consist of the subjects who did not receive any intervention for 6 weeks and were evaluated before and after 6 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Over 65 years old,
- Diagnosed with Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
- Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
- Mini Mental Test score between 13-24 points,
Key exclusion criteria (7 listed)
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Modified Charlson Comorbidity Index score greater than 6,
- Receiving any rehabilitation service from an institution or person,
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 |
|---|---|---|
| ExerciseThe intervention to be carried out in the study consists of physical exercises for the neck, upper and lower extremities, and trunk; It is a program that includes the addition of cognitive tasks such as memory, word finding, processing during each repetition. | Other | Arm 1: Exercise Group |
Primary outcome
Cognitive Function-Mini Mental Test
Time frame: 6 weeks
Mini Mental Test evaluates the cognitive skills. For each question of the test, the correct answer is scored as 1 point, the incorrect answer 0 point. Test is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon; the maximum score is 9.
Timed Up and Go Test
Time frame: 6 weeks
Timed Up and Go Test measure the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.
Physical Mobility-5 Time Sit to Stand Test
Time frame: 6 weeks
5 Time Sit to Stand Test measure the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.
6 secondary outcomes
Balance-One Leg Stance Test
Time frame: 6 weeks
Activities of Daily Living-Katz Activities of Daily Living Scale
Time frame: 6 weeks
Depression-Geriatric Depression Scale
Time frame: 6 weeks
Anxiety-Beck Anxiety Inventory
Time frame: 6 weeks
Burden-Zarit Burden Scale
Time frame: 6 weeks
Well-being-Warwick Edinburgh Mental Well-being Scale
Time frame: 6 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 22 Jul 2021.
- Derived from this study: PubMed 34971285Menengic KN, Yeldan I, Cinar N, Sahiner TA. Effectiveness of home-based telerehabilitation in mild to moderate Alzheimer's disease: A randomised controlled study. Alzheimers Dement. 2021 Dec;17 Suppl 8:e053406. doi: 10.1002/alz.053406.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 Exercise in people with Alzheimer Disease, run by Istanbul University - Cerrahpasa 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 7 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 22 Jul 2021. 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?
Cognitive Function-Mini Mental Test (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606251, which also lists 1 linked publication.
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 22 Jul 2021.