NCT01026155

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

First QC Date

December 3, 2009

Last Update Submit

December 3, 2009

Conditions

Obesity

Keywords

Obese patients (BMI > 30 kg / m²)

Outcome Measures

Primary Outcomes (1)

  • Dyspnea at rest and during exercise

Secondary Outcomes (1)

  • Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire)

Study Arms (2)

Respiratory muscle traininig

EXPERIMENTAL

Low caloric diet and physical activities + Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea

Other: Respiratory muscle training

Control

ACTIVE COMPARATOR

Low caloric diet and physical activities

Other: Respiratory muscle training

Interventions

Respiratory muscle trainingOTHER

Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea

ControlRespiratory muscle traininig

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Respiratory, cardiovascular, musculoskeletal diseases
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Bois de l'Ours

Briançon, 05107, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Bernard Wuyam, MD PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

FR(1)