COPDNCT05053061
Telerehabilitation in COPD
A study testing Application program for pulmonary rehabilitation in people with COPD, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of chronic obstructive pulmonary disease (COPD) in Turkey is 10%. Patients with COPD have a decreased physical capacity. Decreased physical activity in COPD patients causes an increase in all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Application program for pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 31 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Being diagnosed with COPD
- Not have previously participated in pulmonary rehabilitation
- To able to use smartphone
Who cannot join
- Under age 18
- Pregnancy
- Have previously participated in pulmonary rehabilitation
- Having any malignacy
- Having any disorder that limit exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Izmir, 35110
Cenk Kirakli, M.D., 902324333333, samicenk.kirakli@sbu.edu.tr
About this study
Official title: Does Pulmonary Rehabilitation With Telerehabilitation Increase Physical Capacity in Patients With Chronic Obstructive Pulmonary Disease
The prevalence of chronic obstructive pulmonary disease (COPD) in Turkey is 10%. Patients with COPD have a decreased physical capacity. Decreased physical activity in COPD patients causes an increase in all-cause mortality. Pulmonary rehabilitation contributes to increasing physical capacity and quality of life in COPD patients. However, a limited number of patients have access to pulmonary rehabilitation. Some of the patients drop out of pulmonary rehabilitation due to reasons such as transport difficulties, low social support, and low professional support. In addition, disruption of daily routine is one of the important reasons for this situation. Telerehabilitation can enable more patients to access pulmonary rehabilitation. Education and exercise programs can be followed with telerehabilitation in patients with COPD. An increase in exercise capacity and a decrease in dyspnea have been achieved with telerehabilitation in COPD patients.
Different technologies such as telephone, video conferencing or web sites can be used for telerehabilitation. Also, mobile phone was used to telerehabilitation. To make pulmonary telerehabilitation completely patient-based, we have developed an application suitable for smartphones. The application contains videos which showing how to perform pulmonary rehabilitation exercise videos, and it allows the participants to follow up compliance with pulmonary rehabilitation daily. The application will be downloaded to the smartphones of the participants, and it will be shown how to use the application. Participants will not be shown pulmonary rehabilitation exercises.
This study aims to evaluate the effectiveness of telerehabilitation with the application program on physical capacity, quality of life, and dyspnea perception in COPD patients.
- Conditions
- COPD
- Being tested
- Application program for pulmonary rehabilitation
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation
- 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.
Application program for pulmonary rehabilitationBehavioural
Exercise videos for pulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Arm | Experimental | Not described Receives: Behavioral: Application program for pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk test (6MWT)
exercise capacity
Measured: 8 weeks
Secondary outcomes (2)
Short Form-36 (SF-36)
Quality of life
Measured: 8 weeks
St George's Respiratory Questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start25 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053061
- Sponsor's protocol ID
- IGHCEAH-ICU6
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2021
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pulmonary Rehabilitation With Telerehabilitation Increase Physical Capacity in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05053061
- Acronym / sponsor ID
- IGHCEAH-ICU6
- Conditions
- COPD
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 22 Sep 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.
The prevalence of chronic obstructive pulmonary disease (COPD) in Turkey is 10%. Patients with COPD have a decreased physical capacity. Decreased physical activity in COPD patients causes an increase in all-cause mortality. Pulmonary rehabilitation contributes to increasing physical capacity and quality of life in COPD patients. However, a limited number of patients have access to pulmonary rehabilitation. Some of the patients drop out of pulmonary rehabilitation due to reasons such as transport difficulties, low social support, and low professional support. In addition, disruption of daily routine is one of the important reasons for this situation. Telerehabilitation can enable more patients to access pulmonary rehabilitation. Education and exercise programs can be followed with telerehabilitation in patients with COPD. An increase in exercise capacity and a decrease in dyspnea have been achieved with telerehabilitation in COPD patients.
Different technologies such as telephone, video conferencing or web sites can be used for telerehabilitation. Also, mobile phone was used to telerehabilitation. To make pulmonary telerehabilitation completely patient-based, we have developed an application suitable for smartphones. The application contains videos which showing how to perform pulmonary rehabilitation exercise videos, and it allows the participants to follow up compliance with pulmonary rehabilitation daily. The application will be downloaded to the smartphones of the participants, and it will be shown how to use the application. Participants will not be shown pulmonary rehabilitation exercises.
This study aims to evaluate the effectiveness of telerehabilitation with the application program on physical capacity, quality of life, and dyspnea perception in COPD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Arm | Experimental | Behavioral: Application program for pulmonary rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Being diagnosed with COPD
- Not have previously participated in pulmonary rehabilitation
- To able to use smartphone
Key exclusion criteria (5 listed)
- Under age 18
- Pregnancy
- Have previously participated in pulmonary rehabilitation
- Having any malignacy
- Having any disorder that limit exercise
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 |
|---|---|---|
| Application program for pulmonary rehabilitationExercise videos for pulmonary rehabilitation | Behavioural | Telerehabilitation Arm |
Primary outcome
6-min walk test (6MWT)
Time frame: 8 weeks
exercise capacity
2 secondary outcomes
Short Form-36 (SF-36)
Time frame: 8 weeks
St George's Respiratory Questionnaire
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Izmir, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application program for pulmonary rehabilitation in people with COPD, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital 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 4 inclusion and 5 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 15 Oct 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test (6MWT) (time frame: 8 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 15 Oct 2024.