NCT00922857

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

8.4 years

First QC Date

June 16, 2009

Last Update Submit

July 23, 2014

Conditions

Respiratory Insufficiency

Keywords

Respiratory InsufficiencyMuscular AtrophyRespiratory rehabilitation

Outcome Measures

Primary Outcomes (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

    before and at the outcome of the reconditioning program in the effort

Secondary Outcomes (1)

  • Quality of life assessed by questionnaire

    before and at the outcome of the reconditioning program in the effort

Study Arms (1)

Respiratory rehabilitation

EXPERIMENTAL
Procedure: Respiratory rehabilitation

Interventions

Respiratory rehabilitationPROCEDURE

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

Respiratory rehabilitation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Costes F, Gosker H, Feasson L, Desgeorges M, Kelders M, Castells J, Schols A, Freyssenet D. Impaired exercise training-induced muscle fiber hypertrophy and Akt/mTOR pathway activation in hypoxemic patients with COPD. J Appl Physiol (1985). 2015 Apr 15;118(8):1040-9. doi: 10.1152/japplphysiol.00557.2014. Epub 2015 Feb 19.

    PMID: 25701004DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyMuscular Atrophy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Frédéric COSTES, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

April 1, 2005

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

FR(1)