- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026155
Respiratory Muscle Endurance Training in Obese Patients
December 3, 2009 updated by: Fondation Edith Seltzer
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 Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Briançon, France, 05107
- Centre Bois de l'Ours
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Respiratory, cardiovascular, musculoskeletal diseases
- Alcoholism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Respiratory muscle traininig
Low caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
|
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
|
ACTIVE_COMPARATOR: Control
Low caloric diet and physical activities
|
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Dyspnea at rest and during exercise
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Secondary Outcome Measures
Outcome Measure |
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Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 3, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (ESTIMATE)
December 4, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 4, 2009
Last Update Submitted That Met QC Criteria
December 3, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Respob
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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