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Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure (INSPIRE)

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ClinicalTrials.gov Identifier: NCT00922857
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : July 24, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance, this relates to 50,000 patients in France, life expectancy is very limited, and quality of life is poor.

CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are not yet established. Recently, a chronic inflammatory condition has been quoted as a putative cause. This chronic inflammation would involve the molecular mechanisms leading to poor regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could explain a lack of protein synthesis.

It is now well established that respiratory rehabilitation, including a program of exercise reconditioning, increases tolerance to exercise and improve the quality of life. Besides the classical type of endurance exercises stimulating the cardio-respiratory system, it is suggested to add resistance exercises. Several studies have reported the benefit of this strategy but the link with intracellular molecular pathways has not been described; moreover, it is unknown whether the existence of an initial muscular atrophy influences the gain in muscle strength/mass.

Condition or disease Intervention/treatment
Respiratory Insufficiency Procedure: Respiratory rehabilitation

Detailed Description:

We therefore propose to explore the effect of a rehabilitation program including endurance and resistance exercises on muscle biopsies.

The present study should help to know the molecular pathways implicated in muscle atrophy in CRF patients and to assess their evolution with rehabilitation. This could lead to individualized recommendation for exercise program according to the muscle mass of the patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure
Study Start Date : April 2005
Primary Completion Date : September 2013
Study Completion Date : September 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Respiratory rehabilitation Procedure: Respiratory rehabilitation
The training begins 5 days after the initial assessment. It consists of 3 weekly sessions for 8 consecutive weeks, including the following activities interspersed with periods of rest, according to the needs of patients

Outcome Measures

Primary Outcome Measures :
  1. Gain in exercise tolerance (relative variation of the 6 min walking distance and maximal exercise capacity on bicycle (peak VO2) combined with activation of the pathway for muscle protein synthesis [ Time Frame: before and at the outcome of the reconditioning program in the effort ]

Secondary Outcome Measures :
  1. Quality of life assessed by questionnaire [ Time Frame: before and at the outcome of the reconditioning program in the effort ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Prescription of an exercise training program as part of a respiratory rehabilitation
  • Existence of an obstructive ventilatory deficit
  • Signature of written consent

Exclusion Criteria:

  • Exacerbation of COPD
  • Patient with a long-term oxygen therapy
  • Active smoker
  • Lower limb locomotor limitation preventing to achieve the full respiratory rehabilitation program
  • Lower limbs arteritis
  • Myocardial infarction or pulmonary embolism of less than 3 months
  • Long term anticoagulant
  • Type 1 diabetes
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922857

CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Frédéric COSTES, MD PhD CHU de Saint-Etienne
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00922857     History of Changes
Other Study ID Numbers: 0408079
2005/0023 ( Other Identifier: DGS )
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Respiratory Insufficiency
Muscular Atrophy
Respiratory rehabilitation

Additional relevant MeSH terms:
Respiratory Insufficiency
Muscular Atrophy
Pulmonary Valve Insufficiency
Pathological Conditions, Anatomical
Respiration Disorders
Respiratory Tract Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases