COPD PatientsNCT01183052
Mitochondrial Dysfunction and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Training in people with COPD Patients, run by 5 Santé at 2 sites in France.
Trial summary
The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- COPD Patients
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2009to Dec 2010
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary mild to severe COPD patients
Who cannot join
- Neuromuscular disease
- Chronic heart failure
- Renal diseases
- Liver diseases
- Obesity
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique du Souffle La Vallonie
Lodève, 34700
Clinique du Souffle la Solane
Osséja, 66340
About this study
Official title: Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients
The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.
Read the detailed description
Training protocol used is based on recommendations (Nici et al., 2006) and was previously used in our group (Varray et al., 1991; Vallet et al., 1997). A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.
- Conditions
- COPD Patients
- Being tested
- Training
- Keywords
- COPD, exercise tolerance, oxidative stress
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called CT
20 sessions of training
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | 20 sessions of training Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular effects of exercise training at the ventilatory threshold intensity
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional Universitaire Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Maurice MH Hayot, MCU-PH, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183052
- Sponsor's protocol ID
- 2009-A00426-51
- Status last verified
- Sep 2012
- First submitted
- 16 Aug 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients
- ClinicalTrials.gov ID
- NCT01183052
- Acronym / sponsor ID
- 2009-A00426-51
- Conditions
- COPD Patients
- Keywords
- COPD, exercise tolerance, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional Universitaire Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Aug 2010 (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 purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.
Detailed description
Training protocol used is based on recommendations (Nici et al., 2006) and was previously used in our group (Varray et al., 1991; Vallet et al., 1997). A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Other: Training20 sessions of training |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedentary mild to severe COPD patients
Key exclusion criteria (5 listed)
- Neuromuscular disease
- Chronic heart failure
- Renal diseases
- Liver diseases
- Obesity
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 |
|---|---|---|
| TrainingAlso: CT20 sessions of training | Other | Training |
Primary outcome
Cellular effects of exercise training at the ventilatory threshold intensity
Time frame: 6 to 8 weeks
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 5 Sep 2012.
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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.
Maurice MH Hayot, MCU-PH principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with COPD Patients, run by 5 Santé at 2 sites 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 1 inclusion and 5 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 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cellular effects of exercise training at the ventilatory threshold intensity (time frame: 6 to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2012.