COPDNCT01223807
Effects of a Diaphragmatic Breathing Training Program in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Diaphragmatic breathing training in people with COPD, run by University of Sao Paulo.
Trial summary
Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Diaphragmatic breathing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2009
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: (1) age between 50 and 80 years; (2) a post-bronchodilator forced expiratory volume in one second (FEV1) < 80% of the predicted value and a FEV1/ forced vital capacity (CVF) ratio < 0,7; (3) stable respiratory/clinical condition without changes in medication and symptoms (dyspnea, volume or color of sputum) for at least 4 weeks before admission to the study; and (4) receiving regular treatment with inhaled bronchodilators and steroids.
Exclusion Criteria: (1) presence of other pulmonary, cardiovascular or musculoskeletal diseases; (2) previously participation in any exercise-training program in the last 2 years before participating in this study; and (3) current smokers.
About this study
Official title: Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.
Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.
- Conditions
- COPD
- Being tested
- Diaphragmatic breathing training
- Keywords
- COPD, diaphragm, rehabilitation
- 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.
Diaphragmatic breathing trainingOther
The training group will participate in a diaphragmatic breathing program which will consist of three 45-min sessions each week (12 sessions totally). The program training will be individualized and supervised by the same physiotherapist. In each session, the patients will be initially instructed to perform 3 series of 10 maximally inspirations, predominantly with abdominal motion, while reducing upper rib cage motion in a supine position.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive only usual care. |
| Diaphragmatic breathing training | Experimental | The training group will be submitted to a diaphragmatic breathing training program of 4 weeks. Receives: Other: Diaphragmatic breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
thoracoabdominal motion
Measured: 2 years
Secondary outcomes (1)
diaphragmatic mobility
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223807
- Sponsor's protocol ID
- uspferd
- Status last verified
- Jun 2008
- First submitted
- 15 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamaguti WP, Claudino RC, Neto AP, Chammas MC, Gomes AC, Salge JM, Moriya HT, Cukier A, Carvalho CR. Diaphragmatic breathing training program improves abdominal motion during natural breathing in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Apr;93(4):571-7. doi: 10.1016/j.apmr.2011.11.026.
PubMed 22464088
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01223807
- Acronym / sponsor ID
- uspferd
- Conditions
- COPD
- Keywords
- COPD, diaphragm, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 19 Oct 2010 (estimated)
- 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.
Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.
Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive only usual care. |
| Diaphragmatic breathing training | Experimental | Other: Diaphragmatic breathing trainingThe training group will be submitted to a diaphragmatic breathing training program of 4 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Diaphragmatic breathing trainingThe training group will participate in a diaphragmatic breathing program which will consist of three 45-min sessions each week (12 sessions totally). The program training will be individualized and supervised by the same physiotherapist. In each session, the patients will be initially instructed to perform 3 series of 10 maximally inspirations, predominantly with abdominal motion, while reducing upper rib cage motion in a supine position. | Other | Diaphragmatic breathing training |
Primary outcome
thoracoabdominal motion
Time frame: 2 years
1 secondary outcome
diaphragmatic mobility
Time frame: 2 years
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 19 Oct 2010.
- Derived from this study: PubMed 22464088Yamaguti WP, Claudino RC, Neto AP, Chammas MC, Gomes AC, Salge JM, Moriya HT, Cukier A, Carvalho CR. Diaphragmatic breathing training program improves abdominal motion during natural breathing in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Apr;93(4):571-7. doi: 10.1016/j.apmr.2011.11.026.
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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 Diaphragmatic breathing training in people with COPD, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Oct 2010. 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?
thoracoabdominal motion (time frame: 2 years). 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 NCT01223807, 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 19 Oct 2010.