ObesityNCT01026155
Respiratory Muscle Endurance Training in Obese Patients
A study testing Respiratory muscle training in people with Obesity, run by Fondation Edith Seltzer at 1 site in France.
Trial summary
Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Respiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese patients (BMI > 30 kg/m2), without respiratory pathology (VEMS > 80% predicted, VEMS/CV > 80%)
- men or women
- age between 18 and 60 years old
Who cannot join
- Respiratory, cardiovascular, musculoskeletal diseases
- Alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.
- Conditions
- Obesity
- Being tested
- Respiratory muscle training
- Keywords
- Obese patients (BMI > 30 kg / m²)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingOther
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
| Study group | Role | What they receive |
|---|---|---|
| Respiratory muscle traininig | Experimental | Low caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea Receives: Other: Respiratory muscle training |
| Control | Active comparator | Low caloric diet and physical activities Receives: Other: Respiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea at rest and during exercise
Secondary outcomes (1)
Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Edith Seltzer
- Sponsor type
- University, hospital or other
- Investigators
- Bernard Wuyam, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026155
- Sponsor's protocol ID
- Respob
- Status last verified
- Dec 2009
- First submitted
- 3 Dec 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Endurance Training in Obese Patients
- ClinicalTrials.gov ID
- NCT01026155
- Acronym / sponsor ID
- Respob
- Conditions
- Obesity
- Keywords
- Obese patients (BMI > 30 kg / m²)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondation Edith SeltzerUniversity, hospital or other
- First posted
- 4 Dec 2009 (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.
Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle traininig | Experimental | Other: Respiratory muscle trainingLow caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea |
| Control | Active comparator | Other: Respiratory muscle trainingLow caloric diet and physical activities |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese patients (BMI > 30 kg/m2), without respiratory pathology (VEMS > 80% predicted, VEMS/CV > 80%)
- men or women
- age between 18 and 60 years old
Key exclusion criteria (2 listed)
- Respiratory, cardiovascular, musculoskeletal diseases
- Alcoholism
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 |
|---|---|---|
| Respiratory muscle trainingRespiratory muscle endurance training by means of isocapnic voluntary hyperpnoea | Other | Control, Respiratory muscle traininig |
Primary outcome
Dyspnea at rest and during exercise
1 secondary outcome
Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire)
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 4 Dec 2009.
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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.
Bernard Wuyam, MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Obesity, run by Fondation Edith Seltzer at 1 site in France.
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 2 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 4 Dec 2009. 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 France. 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?
Dyspnea at rest and during exercise. 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 4 Dec 2009.