TelerehabilitationNCT04484389
Telerehabilitation in Individuals With Chronic Disease
A study testing Telerehabilitation and Exercise brochure in people with Telerehabilitation, run by Istinye University.
Trial summary
Telerehabilitation applications are a treatment method that uses new technologies. There are examples of doing for many diseases in our country. It is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Telerehabilitation and Exercise brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2020to 31 Aug 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a chronic disease
- To be able to communicate verbally
- Being in a stable period in terms of disease
- At least 3 months for the disease to be chronic
- Regulated hypertension
- Diabetes patients should have them blood sugar under 200 during therapy
Who cannot join
- Dementia
- Being a cancer patient receiving chemotherapy
- Epilepsy and a history of seizures
- Patient who has recently undergone surgery
- Pregnancy
- Delirium
- Bedridden
About this study
Official title: Effects of Exercise With Telerehabilitation on Depression, Quality of Life and Fatigue in Individuals With Chronic Disease
Telerehabilitation applications are a treatment method that uses new technologies. There are examples of doing for many diseases in our country. It is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. In our study, we will use the telerehabilitation system. In this system, which we will use in people with chronic disease, we aim to see improvement in tests performed in many areas such as physical activity level, respiratory capacity, depression, and anxiety level of patients.
In the study to be performed on 60 patients, 30 people will be control and 30 people will be the experimental group. The experimental group will be treated with a video conferencing method, tailor-made exercise program based on the international physical activity questionnaire level for 30 minutes 3 days a week for 6 weeks. The control group will only be informed with the help of a brochure with a standard exercise program.
The tests we can use in this experiment are as follows: Barthel daily life activities index, beck depression and anxiety scale, ferrans power quality of life index, Charlson comorbidity index, environmental measurements, waist/hip ratio, fatigue severity scale, international physical activity questionnaire. Tests specific to chronic diseases will be applied to patient one to one.
- Conditions
- Telerehabilitation
- Being tested
- Telerehabilitation, Exercise brochure
- Keywords
- Chronic Disease, Exercises, Social Isolation
- Medical subject headings
- Chronic Disease, Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Exercise protocol according to Ipaq will be prepared for 30 patients with chronic disease . Exercise protocol; warm-up exercises include, stretching exercises, postural exercises, aerobic exercise and cooling exercises. People will practice the exercises 3 days a week for 6 weeks. People will need to reserve 30 minutes a day for this study.
Exercise brochureOther
General exercise protocol will be prepared and given to the control group as a brochure
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Individual exercises will be applied to individuals with Chronic disease. Receives: Other: Telerehabilitation |
| Control Group | Active comparator | Group to be given an exercise brochure Receives: Other: Exercise brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Beck Depression Inventory is a 21-question multiple-choice self-report inventory The Beck Depression Inventory takes approximately 10 minutes to complete. The minimum score that can be obtained from the scale is 0 and the maximum score is 63 . Higher total scores indicate more severe depressive symptoms.
Measured: 2 weeks
Secondary outcomes (1)
Charlson Comorbidity Index
The Charlson Comorbidity Index is a method of categorizing comorbidities of patients. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Aug 2020 (estimated)
- Primary completion15 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevval Bakir, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484389
- Sponsor's protocol ID
- 015
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise With Telerehabilitation on Depression, Quality of Life and Fatigue in Individuals With Chronic Disease
- ClinicalTrials.gov ID
- NCT04484389
- Acronym / sponsor ID
- 015
- Conditions
- Telerehabilitation
- Keywords
- Chronic Disease, Exercises, Social Isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 23 Jul 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.
Telerehabilitation applications are a treatment method that uses new technologies. There are examples of doing for many diseases in our country. It is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. In our study, we will use the telerehabilitation system. In this system, which we will use in people with chronic disease, we aim to see improvement in tests performed in many areas such as physical activity level, respiratory capacity, depression, and anxiety level of patients.
In the study to be performed on 60 patients, 30 people will be control and 30 people will be the experimental group. The experimental group will be treated with a video conferencing method, tailor-made exercise program based on the international physical activity questionnaire level for 30 minutes 3 days a week for 6 weeks. The control group will only be informed with the help of a brochure with a standard exercise program.
The tests we can use in this experiment are as follows: Barthel daily life activities index, beck depression and anxiety scale, ferrans power quality of life index, Charlson comorbidity index, environmental measurements, waist/hip ratio, fatigue severity scale, international physical activity questionnaire. Tests specific to chronic diseases will be applied to patient one to one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: TelerehabilitationIndividual exercises will be applied to individuals with Chronic disease. |
| Control Group | Active comparator | Other: Exercise brochureGroup to be given an exercise brochure |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a chronic disease
- To be able to communicate verbally
- Being in a stable period in terms of disease
- At least 3 months for the disease to be chronic
- Regulated hypertension
Key exclusion criteria (7 listed)
- Dementia
- Being a cancer patient receiving chemotherapy
- Epilepsy and a history of seizures
- Patient who has recently undergone surgery
- Pregnancy
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 |
|---|---|---|
| TelerehabilitationExercise protocol according to Ipaq will be prepared for 30 patients with chronic disease . Exercise protocol; warm-up exercises include, stretching exercises, postural exercises, aerobic exercise and cooling exercises. People will practice the exercises 3 days a week for 6 weeks. People will need to reserve 30 minutes a day for this study. | Other | Study Group |
| Exercise brochureGeneral exercise protocol will be prepared and given to the control group as a brochure | Other | Control Group |
Primary outcome
Beck Depression Inventory
Time frame: 2 weeks
The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Beck Depression Inventory is a 21-question multiple-choice self-report inventory The Beck Depression Inventory takes approximately 10 minutes to complete. The minimum score that can be obtained from the scale is 0 and the maximum score is 63 . Higher total scores indicate more severe depressive symptoms.
1 secondary outcome
Charlson Comorbidity Index
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Exercise brochure in people with Telerehabilitation, run by Istinye University.
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 6 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Beck Depression Inventory (time frame: 2 weeks). 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 30 Jul 2020.