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Respiratory Muscle Endurance Training in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Fondation Edith Seltzer
ClinicalTrials.gov Identifier:
NCT01026155
First received: December 3, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
 Other: Respiratory muscle training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Respiratory Muscle Endurance Training in Obese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondation Edith Seltzer:

Primary Outcome Measures:
  • Dyspnea at rest and during exercise [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire) [ Designated as safety issue: No ]

Enrollment: 20
Arms Assigned Interventions
Experimental: Respiratory muscle traininig
Low caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
 Other: Respiratory muscle training
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
Active Comparator: Control
Low caloric diet and physical activities
 Other: Respiratory muscle training
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026155

Locations
France
Centre Bois de l'Ours
Briançon, France, 05107
Sponsors and Collaborators
Fondation Edith Seltzer
Investigators
Principal Investigator: Bernard Wuyam, MD PhD University Hospital, Grenoble
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01026155     History of Changes
Other Study ID Numbers: Respob
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: France: INSERM

Keywords provided by Fondation Edith Seltzer:
Obese patients (BMI > 30 kg / m²)

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013