TelerehabilitationNCT04694729
Telerehabilitation Approaches in Chronic Obstructive Pulmonary Patients
A study testing videoconference-based and video-based in people with Telerehabilitation and COPD, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary rehabilitation (PR) is a first-line management strategy in chronic obstructive pulmonary patients (COPD) as it reduces shortness of breath, increases exercise capacity, and improves health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telerehabilitation, COPD
- What is being tested?
- videoconference-based and video-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with COPD (FEV1 / FVC <70% in the stable phase of the disease)
- Age > 18 years old
- Have the ability to use a smartphone
Who cannot join
- Musculoskeletal disorders that limit exercise
- Dizziness, significant sensory or motor impairments, dementia or terminal illnesses that prevent education
- Serious comorbidities such as unstable heart disease, irregular diabetes, known malignant disease, any other disease that makes the patient unsuitable for participation in the study.
- Incompatible patient
- Severe vision or hearing impairment
- Unwillingness or inability to follow the protocol
- Have had a COPD exacerbation in the previous 6 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: Comparison of the Effectiveness of Different Telerehabilitation Approaches in Chronic Obstructive Pulmonary Patients
Pulmonary rehabilitation (PR) is a first-line management strategy in chronic obstructive pulmonary patients (COPD) as it reduces shortness of breath, increases exercise capacity, and improves health-related quality of life. However, 8-50% of patients referred to PR do not participate at all, while 10-32% of those who start do not complete the program. Barriers to participation and completion include difficulty in accessing the program, poor mobility, lack of transport, and travel costs. Telerehabilitation is defined as the provision of rehabilitation services through telecommunication technology, including telephone, internet and video conference communications between the patient and the healthcare provider. Different technologies (from phone to video conferencing) have been tested in patients with COPD to enhance daily activities, exercise training and walking prescription. All of them showed positive effects on exercise tolerance, dyspnea, physical activity and quality of life. However, there is no study about which telerehabilitation program is more effective on COPD patients. The aim of this study is to investigate which telerehabilitation approach is more effective in COPD.
- Conditions
- Telerehabilitation, COPD
- Being tested
- videoconference-based, video-based
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoconference-basedOther
Exercises will be done 3 days a week for 6 weeks, with the help of a physiotherapist via video conference.
video-basedOther
The exercise video will be sent to the patients and they will do it 3 days a week for 6 weeks. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Videoconference-based Receives: Other: videoconference-based |
| control group | Experimental | Video-based Receives: Other: video-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test(6MWT)
Measured: 6 week
Pulmonary function testing
Measured: 6 week
Secondary outcomes (9)
30-Second Chair Stand Test
Measured: 6 week
Time Up and Go Test
Measured: 6 week
Copd Assessment Test
Measured: 6 week
St George's Respiratory Questionnaire
Measured: 6 week
Hospital Anxiety and Depression Scale
Measured: 6 week
Medical Research Council Scale
Measured: 6 week
Short Physical Performance Battery
Measured: 6 week
International Physical Activity Questionnaire-Short Form
Measured: 6 week
Static Lung Volumes
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2021
- Primary completionMar 2021 (estimated)
- Study completionDec 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 Saglik Bilimleri UniversitesiThe 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursima Bulut, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694729
- Sponsor's protocol ID
- TeleCOPD
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Different Telerehabilitation Approaches in Chronic Obstructive Pulmonary Patients
- ClinicalTrials.gov ID
- NCT04694729
- Acronym / sponsor ID
- TeleCOPD
- Conditions
- Telerehabilitation, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 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.
Pulmonary rehabilitation (PR) is a first-line management strategy in chronic obstructive pulmonary patients (COPD) as it reduces shortness of breath, increases exercise capacity, and improves health-related quality of life. However, 8-50% of patients referred to PR do not participate at all, while 10-32% of those who start do not complete the program. Barriers to participation and completion include difficulty in accessing the program, poor mobility, lack of transport, and travel costs. Telerehabilitation is defined as the provision of rehabilitation services through telecommunication technology, including telephone, internet and video conference communications between the patient and the healthcare provider. Different technologies (from phone to video conferencing) have been tested in patients with COPD to enhance daily activities, exercise training and walking prescription. All of them showed positive effects on exercise tolerance, dyspnea, physical activity and quality of life. However, there is no study about which telerehabilitation program is more effective on COPD patients. The aim of this study is to investigate which telerehabilitation approach is more effective in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: videoconference-basedVideoconference-based |
| control group | Experimental | Other: video-basedVideo-based |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with COPD (FEV1 / FVC <70% in the stable phase of the disease)
- Age > 18 years old
- Have the ability to use a smartphone
Key exclusion criteria (7 listed)
- Musculoskeletal disorders that limit exercise
- Dizziness, significant sensory or motor impairments, dementia or terminal illnesses that prevent education
- Serious comorbidities such as unstable heart disease, irregular diabetes, known malignant disease, any other disease that makes the patient unsuitable for participation in the study.
- Incompatible patient
- Severe vision or hearing impairment
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 |
|---|---|---|
| videoconference-basedExercises will be done 3 days a week for 6 weeks, with the help of a physiotherapist via video conference. | Other | study group |
| video-basedThe exercise video will be sent to the patients and they will do it 3 days a week for 6 weeks. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week. | Other | control group |
Primary outcome
6 minute walk test(6MWT)
Time frame: 6 week
Pulmonary function testing
Time frame: 6 week
9 secondary outcomes
30-Second Chair Stand Test
Time frame: 6 week
Time Up and Go Test
Time frame: 6 week
Copd Assessment Test
Time frame: 6 week
St George's Respiratory Questionnaire
Time frame: 6 week
Hospital Anxiety and Depression Scale
Time frame: 6 week
Medical Research Council Scale
Time frame: 6 week
Short Physical Performance Battery
Time frame: 6 week
International Physical Activity Questionnaire-Short Form
Time frame: 6 week
Static Lung Volumes
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videoconference-based and video-based in people with Telerehabilitation and COPD, run by Saglik Bilimleri Universitesi 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 3 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 6 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nursima Bulut Physiotherapist (2163463636, bltnursima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test(6MWT) (time frame: 6 week). The study lists 2 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 6 Jan 2021.