Pulmonary RehabilitationNCT04088669
Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
A study testing Home-based Pulmonary Rehabilitation and Education and Recommendations in people with Pulmonary Rehabilitation and Asthma, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Rehabilitation, Asthma, Home-based Pulmonary Rehabilitation
- What is being tested?
- Home-based Pulmonary Rehabilitation and Education and Recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Feb 2019to 10 Nov 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with asthma
- Acceptance of persons to participate in the study
- Being in the 18-65 age range
Who cannot join
- Presence of an orthopedic, neurological, systemic disease that prevents the exercise
- Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
- Exercising 3 or more days a week
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem Vakıf University
Istanbul, Eyüp
Bahçelievler Public Hospital
Istanbul
About this study
Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be preferred because it is more cost-effective and patients can spend more time with their families. There are a limited number of studies in the literature evaluating the efficacy of home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment in asthmatic patients.
- Being tested
- Home-based Pulmonary Rehabilitation, Education and Recommendations
- Keywords
- asthma, pulmonary rehabilitation, home-based pulmonary rehabilitation, home-based rehabilitation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Pulmonary RehabilitationOther
Patients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking). All of these exercises will be equipped with equipment that the patients can easily provide at home. In addition, patients will be provided with a pedometer and exercise diary.
Education and RecommendationsOther
The control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on physical activity recommendations. Patients will be given a pedometer and diary.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. Receives: Other: Home-based Pulmonary Rehabilitation |
| Control group | Active comparator | A training session about the disease and the correct inhaler use, booklets that include physical activity recommendations. Receives: Other: Education and Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Change of Six-Minute Walking Test Distance from baseline to 8 weeks.The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
Measured: 8 weeks
Peak Expiratory Flow
Change of Expiratory Flow (PEF) from baseline to 8 weeks.
Measured: 8 weeks
Forced Expiratory Volume in 1 second
Change of Forced Expiratory Volume in 1 second (FEV1) from baseline to 8 weeks.
Measured: 8 weeks
Control of Asthma
Change of Asthma Control Test from baseline to 8 weeks. The Asthma Control Test is a 5-item questionnaire that enables the patient to assess his / her own level of exposure to asthma activities, frequency of day and night asthma symptoms, need for rescue medication, and disease control. Patients will be asked to answer the asthma control test, which includes scores associated with the answer to each question, and the total score will be 25 if complete control, 20-24 as partial control, and <19 as uncontrolled.
Measured: 8 weeks
Dyspnoea
Change of Medical Research Council Scale results from baseline to 8 weeks. The Medical Research Council Scale (MRCS) is a five-item scale based on various physical activities that produce dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea in themselves. On the scale, 0 describes the best 4 dyspnea and the worst.
Measured: 8 weeks
Secondary outcomes (3)
Lower Extremity Strength and Dynamic Balance
Change of 30 seconds sit and stand test results from baseline to 8 weeks.
Measured: 8 weeks
Health Related Quality of Life
Change of Saint George Respiratory Questionnaire Results from baseline to 8 weeks.It is a self-answered questionnaire consisting of three categories, evaluating the symptoms, activities and effects of patients on daily life. It was developed in order to determine the severity of the disease as more comprehensive and sensitive. Symptoms examined; cough, sputum, wheezing and shortness of breath. Physical functions, housework and hobbies are questioned to determine activity status. The survey consists of 76 questions and is completed in 20 minutes. 0 indicates excellent health and 100 indicates worst health.
Measured: 8 weeks
Activity of Daily Living
Change of London Chest Activity of Daily Living Scale results from baseline to 8 weeks. This questionnaire consisting of 15 items; personal care (4 items-dry, dress up upper body, wear shoes / socks, wash hair), housework (make 6 items-bed, change sheets, window / curtain wash, clean / remove dust, wash dishes, sweep), physical activity (2 items-stairs, leaning) and leisure (3 items-walking in the house, socially go out, talk) consists of four components. Each item is given a score ranging from 0 to 5. Higher scores indicate higher limitation. The scale can be evaluated as total score, component score and question score. The total score can reach up to 75.
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 posted13 Sep 2019
- Study start25 Feb 2019
- Primary completion10 Nov 2019
- Study completion10 Nov 2019
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 Pulmonary RehabilitationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sena Manzak, Bezmialem Vakif University
- Investigators
- Ayşe Sena Manzak, PhD Student, Principal investigator, Bezmialem Vakif UniversitySemiramis Özyılmaz, Assoc. Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088669
- Sponsor's protocol ID
- BVUaysesena01
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2019
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dursun ASM, Ozyilmaz S, Guney PA, Tak AY. Effectiveness of a home-based exercise program on functional outcomes in women with asthma: A randomized controlled trial. BMC Pulm Med. 2026 Jun 19. doi: 10.1186/s12890-026-04437-2. Online ahead of print.
PubMed 42321765
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
- ClinicalTrials.gov ID
- NCT04088669
- Acronym / sponsor ID
- BVUaysesena01
- Keywords
- asthma, pulmonary rehabilitation, home-based pulmonary rehabilitation, home-based rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 13 Sep 2019 (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.
Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be preferred because it is more cost-effective and patients can spend more time with their families. There are a limited number of studies in the literature evaluating the efficacy of home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment in asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home-based Pulmonary RehabilitationA home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. |
| Control group | Active comparator | Other: Education and RecommendationsA training session about the disease and the correct inhaler use, booklets that include physical activity recommendations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with asthma
- Acceptance of persons to participate in the study
- Being in the 18-65 age range
Key exclusion criteria (3 listed)
- Presence of an orthopedic, neurological, systemic disease that prevents the exercise
- Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
- Exercising 3 or more days a week
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 |
|---|---|---|
| Home-based Pulmonary RehabilitationPatients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking). All of these exercises will be equipped with equipment that the patients can easily provide at home. In addition, patients will be provided with a pedometer and exercise diary. | Other | Intervention group |
| Education and RecommendationsThe control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on physical activity recommendations. Patients will be given a pedometer and diary. | Other | Control group |
Primary outcome
Functional Capacity
Time frame: 8 weeks
Change of Six-Minute Walking Test Distance from baseline to 8 weeks.The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
Peak Expiratory Flow
Time frame: 8 weeks
Change of Expiratory Flow (PEF) from baseline to 8 weeks.
Forced Expiratory Volume in 1 second
Time frame: 8 weeks
Change of Forced Expiratory Volume in 1 second (FEV1) from baseline to 8 weeks.
Control of Asthma
Time frame: 8 weeks
Change of Asthma Control Test from baseline to 8 weeks. The Asthma Control Test is a 5-item questionnaire that enables the patient to assess his / her own level of exposure to asthma activities, frequency of day and night asthma symptoms, need for rescue medication, and disease control. Patients will be asked to answer the asthma control test, which includes scores associated with the answer to each question, and the total score will be 25 if complete control, 20-24 as partial control, and <19 as uncontrolled.
Dyspnoea
Time frame: 8 weeks
Change of Medical Research Council Scale results from baseline to 8 weeks. The Medical Research Council Scale (MRCS) is a five-item scale based on various physical activities that produce dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea in themselves. On the scale, 0 describes the best 4 dyspnea and the worst.
3 secondary outcomes
Lower Extremity Strength and Dynamic Balance
Time frame: 8 weeks
Health Related Quality of Life
Time frame: 8 weeks
Activity of Daily Living
Time frame: 8 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 9 Jan 2026.
- Derived from this study: PubMed 42321765Dursun ASM, Ozyilmaz S, Guney PA, Tak AY. Effectiveness of a home-based exercise program on functional outcomes in women with asthma: A randomized controlled trial. BMC Pulm Med. 2026 Jun 19. doi: 10.1186/s12890-026-04437-2. Online ahead of print.
Related trials for Pulmonary Rehabilitation
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Not yet recruiting
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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Recruiting
Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)
Respiratory Diseases
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
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Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
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.
Ayşe Sena Manzak, PhD Student principal investigator
Bezmialem Vakif University
Semiramis Özyılmaz, Assoc. Prof. study director
Bezmialem Vakif University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Pulmonary Rehabilitation and Education and Recommendations in people with Pulmonary Rehabilitation and Asthma, run by Bezmialem Vakif University at 2 sites 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 3 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional Capacity (time frame: 8 weeks). 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 NCT04088669, 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 9 Jan 2026.