Respiratory InsufficiencyINSPIRENCT00922857
Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure
A study testing Respiratory rehabilitation in people with Respiratory Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Respiratory rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescription of an exercise training program as part of a respiratory rehabilitation
- Existence of an obstructive ventilatory deficit
- Signature of written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Respiratory Insufficiency
- Being tested
- Respiratory rehabilitation
- Keywords
- Respiratory Insufficiency, Muscular Atrophy, Respiratory rehabilitation
- Medical subject headings
- Respiratory Insufficiency, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rehabilitationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Respiratory rehabilitation | Experimental | Not described Receives: Procedure: Respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and at the outcome of the reconditioning program in the effort
Secondary outcomes (1)
Quality of life assessed by questionnaire
Measured: before and at the outcome of the reconditioning program in the effort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startApr 2005
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Frédéric COSTES, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922857
- Sponsor's protocol ID
- 0408079
- Other IDs
- 2005/0023
- Acronym
- INSPIRE
- Status last verified
- Jul 2014
- First submitted
- 16 Jun 2009
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25701004
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT00922857
- Acronym / sponsor ID
- INSPIRE / 0408079
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory Insufficiency, Muscular Atrophy, Respiratory rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2005
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory rehabilitation | Experimental | Procedure: Respiratory rehabilitation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prescription of an exercise training program as part of a respiratory rehabilitation
- Existence of an obstructive ventilatory deficit
- Signature of written consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory rehabilitationThe 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 | Procedure or surgery | Respiratory rehabilitation |
Primary outcome
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
1 secondary outcome
Quality of life assessed by questionnaire
Time frame: before and at the outcome of the reconditioning program in the effort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 25701004Costes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric COSTES, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory rehabilitation in people with Respiratory Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.