AsthmaNCT03227341
Pulmonary Rehabilitation in Asthma Control
A study testing Exercise in people with Asthma, run by Izmir Katip Celebi University.
Trial summary
The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines
Who cannot join
- If the initial diagnosis cannot be confirmed, the patient excluded from the study
- Patients were under medical treatment of -6 months and considered clinically stable.
- Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
- Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study
About this study
Official title: Does Pulmonary Rehabilitation Contribute to Asthma Control?
The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.
Read the detailed description
Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma.
Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.
- Conditions
- Asthma
- Being tested
- Exercise
- Keywords
- asthma control, pulmonary rehabilitation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions
| Study group | Role | What they receive |
|---|---|---|
| patients with uncontrolled asthma. | Other | 8 week pulmonary rehabilitation program Receives: Other: Exercise |
| patients with partially controlled asthma | Other | 8 week pulmonary rehabilitation program Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control test score
A test measured the control of asthma
Measured: 4 weeks
Secondary outcomes (6)
Exercise capacity
Six minute walk test
Measured: 6 minute
Dyspnea
MMRC Dyspnea Scale
Measured: 1 year
Quality of Life
St. George Respiratory Questionnaire
Measured: 1 year
Pulmonary Function Test
FEV1, FVC, DLCO
Measured: 1 hour
Arterial Blood Gas
PaO2, PaCO2, SaO2
Measured: 1 hour
Anxiety and Depression
Hospital Anxiety and Depression Scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jan 2013
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227341
- Sponsor's protocol ID
- KCU123
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pulmonary Rehabilitation Contribute to Asthma Control?
- ClinicalTrials.gov ID
- NCT03227341
- Acronym / sponsor ID
- KCU123
- Conditions
- Asthma
- Keywords
- asthma control, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 24 Jul 2017 (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 investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.
Detailed description
Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma.
Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with uncontrolled asthma. | Other | Other: Exercise8 week pulmonary rehabilitation program |
| patients with partially controlled asthma | Other | Other: Exercise8 week pulmonary rehabilitation program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines
Key exclusion criteria (4 listed)
- If the initial diagnosis cannot be confirmed, the patient excluded from the study
- Patients were under medical treatment of -6 months and considered clinically stable.
- Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
- Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study
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 |
|---|---|---|
| Exercise8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions | Other | patients with partially controlled asthma, patients with uncontrolled asthma. |
Primary outcome
Asthma control test score
Time frame: 4 weeks
A test measured the control of asthma
6 secondary outcomes
Exercise capacity
Time frame: 6 minute
Dyspnea
Time frame: 1 year
Quality of Life
Time frame: 1 year
Pulmonary Function Test
Time frame: 1 hour
Arterial Blood Gas
Time frame: 1 hour
Anxiety and Depression
Time frame: 1 week
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 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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 Exercise in people with Asthma, run by Izmir Katip Celebi 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 1 inclusion and 4 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 24 Jul 2017. 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?
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?
Asthma control test score (time frame: 4 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 24 Jul 2017.