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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026155
Other study ID # Respob
Secondary ID
Status Completed
Phase N/A
First received December 3, 2009
Last updated December 3, 2009

Study information

Verified date December 2009
Source Fondation Edith Seltzer
Contact n/a
Is FDA regulated No
Health authority France: INSERM
Study type Interventional

Clinical 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. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Respiratory muscle training
Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea

Locations

Country Name City State
France Centre Bois de l'Ours Briançon

Sponsors (1)

Lead Sponsor Collaborator
Fondation Edith Seltzer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dyspnea at rest and during exercise No
Secondary Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire) No
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