COPDCOPDNCT04879576
The Effects of Telerehabilitation in Patients With COPD
A study testing Treatment in people with COPD, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Not having an attack in the last 2 months
- Volunteering to participate in the study
- Being between the ages of 40-80
- To have a device that can be used in telerehabilitation application and an active internet connection.
Who cannot join
- Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
- Currently addicted to alcohol or drugs
- Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
- Having serious vision and hearing problems
- Having severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale High Specialization Hospital
Kirikkale
Selma Demir, 05054895758, drmed64@gmail.com
About this study
Official title: The Effects of Telerehabilitation on Respiratory Functions, Quality of Life, Exercise Capacity, Fatigue and Psychosocial Factors in Patients With COPD
Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use.
In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.
- Conditions
- COPD
- Being tested
- Treatment
- Keywords
- 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.
TreatmentOther
Also called telerehabilitation
Telerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Other: Treatment |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in respiratory functions on the spirometry at week 8
Spirometry is a standard test doctors use to measure how well your lungs are functioning. The test works by measuring airflow into and out of your lungs.Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Measured: Baseline - Week 8
Change from Baseline in exercise capacity on six-minute walk test at week 8
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.A lower score (reflecting less distance covered in 6 minutes) indicates worse function.
Measured: Baseline - Week 8
Change from Baseline in health-related quality of life on Saint George's Respiratory Questionnaire at week 8
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Baseline - Week 8
Change from Baseline in psychosocial factors on Beck Depression and Beck Anxiety Inventory at week 8
Beck Depression Inventory is a self-assessment scale that determines the risk of individuals in terms of depression and measures the level of depressive symptoms and the change in severity.Beck Anxiety Inventory is a likert type self-assessment scale that determines the frequency of anxiety symptoms experienced by individuals. The high score the individual gets from the scale indicates the severity of anxiety experienced.
Measured: Baseline - Week 8
Change from Baseline in fatigue on COPD and Asthma Fatigue Scale at week 8
The COPD and Asthma Fatigue Scale , was developed for use in clinical trials and other studies in respiratory diseases. The COPD and Asthma Fatigue Scale was intended to be sufficiently comprehensive to capture fatigue experienced by patients with either asthma or COPD, yet be brief and patient centered.
Measured: Baseline - Week 8
Secondary outcomes (1)
Change from Baseline in dyspnea on Modified Medical Research Council Dyspnea Scale at week 8
The modified Medical Research Council (mMRC) scale is the most commonly used validated scale to assess dyspnea in daily living in chronic respiratory diseases. It is a scale scored between 0 and 5 based on various factors causing dyspnea.
Measured: Baseline - Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Apr 2021
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Karakaş, Kırıkkale University
- Investigators
- Beyza Karakaş, Study director, Graduate student at Kırıkkale UniversityMeral Sertel, Study chair, Associate professor at Kırıkkale UniversitySelma Demir, Principal investigator, Chest Diseases Specialist at Kırıkkale High Specialization Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879576
- Sponsor's protocol ID
- KKUniversity
- Acronym
- COPD
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avci B, Sertel M, Demir S. The effect of posture and breathing exercises applied with telerehabilitation on respiratory functions, exercise capacity, fatigue, and psychosocial factors in chronic obstructive pulmonary disease patients. J Bodyw Mov Ther. 2025 Dec;45:953-961. doi: 10.1016/j.jbmt.2025.09.046. Epub 2025 Oct 16.
PubMed 41316669
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation on Respiratory Functions, Quality of Life, Exercise Capacity, Fatigue and Psychosocial Factors in Patients With COPD
- ClinicalTrials.gov ID
- NCT04879576
- Acronym / sponsor ID
- COPD / KKUniversity
- Conditions
- COPD
- Keywords
- Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 May 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.
Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use.
In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Treatment |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Not having an attack in the last 2 months
- Volunteering to participate in the study
- Being between the ages of 40-80
- To have a device that can be used in telerehabilitation application and an active internet connection.
Key exclusion criteria (5 listed)
- Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
- Currently addicted to alcohol or drugs
- Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
- Having serious vision and hearing problems
- Having severe cognitive 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 |
|---|---|---|
| TreatmentAlso: telerehabilitationTelerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week | Other | Treatment Group |
Primary outcome
Change from Baseline in respiratory functions on the spirometry at week 8
Time frame: Baseline - Week 8
Spirometry is a standard test doctors use to measure how well your lungs are functioning. The test works by measuring airflow into and out of your lungs.Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Change from Baseline in exercise capacity on six-minute walk test at week 8
Time frame: Baseline - Week 8
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.A lower score (reflecting less distance covered in 6 minutes) indicates worse function.
Change from Baseline in health-related quality of life on Saint George's Respiratory Questionnaire at week 8
Time frame: Baseline - Week 8
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
Change from Baseline in psychosocial factors on Beck Depression and Beck Anxiety Inventory at week 8
Time frame: Baseline - Week 8
Beck Depression Inventory is a self-assessment scale that determines the risk of individuals in terms of depression and measures the level of depressive symptoms and the change in severity.Beck Anxiety Inventory is a likert type self-assessment scale that determines the frequency of anxiety symptoms experienced by individuals. The high score the individual gets from the scale indicates the severity of anxiety experienced.
Change from Baseline in fatigue on COPD and Asthma Fatigue Scale at week 8
Time frame: Baseline - Week 8
The COPD and Asthma Fatigue Scale , was developed for use in clinical trials and other studies in respiratory diseases. The COPD and Asthma Fatigue Scale was intended to be sufficiently comprehensive to capture fatigue experienced by patients with either asthma or COPD, yet be brief and patient centered.
1 secondary outcome
Change from Baseline in dyspnea on Modified Medical Research Council Dyspnea Scale at week 8
Time frame: Baseline - Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 41316669Avci B, Sertel M, Demir S. The effect of posture and breathing exercises applied with telerehabilitation on respiratory functions, exercise capacity, fatigue, and psychosocial factors in chronic obstructive pulmonary disease patients. J Bodyw Mov Ther. 2025 Dec;45:953-961. doi: 10.1016/j.jbmt.2025.09.046. Epub 2025 Oct 16.
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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.
Beyza Karakaş study director
Graduate student at Kırıkkale University
Meral Sertel study chair
Associate professor at Kırıkkale University
Selma Demir principal investigator
Chest Diseases Specialist at Kırıkkale High Specialization Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with COPD, run by Kırıkkale 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 5 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 10 May 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 Beyza Karakaş (05062187342, beyzakarakas071@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in respiratory functions on the spirometry at week 8 (time frame: Baseline - Week 8). The study lists 5 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 NCT04879576, 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 10 May 2021.