Chronic Obstructive Pulmonary DiseaseSIMNCT01561625
Signaling Pathway Activation After Exercise in Patients With Chronic Obstructive Pulmonary Disease
A study testing exercise in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial summary
Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- exercise
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Apr 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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- COPD with an FEV1 of under 60% of predicted
- non-smoker
- Between 50 and 75 years old
Who cannot join
- All inflammatory disease (HIV, Cancer, renal and cardiac deficiency)
- Hormonal dysregulation
- Inferior limb pathology
- Neuromuscular pathology
- History of tabacco or alcool abuse
- Oxygen dependent
- Recent exacerbation (2 months) of the symptoms of COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Signaling Pathway Activation in the Quadriceps of Patients With COPD After an Acute Bout of Resistance
Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. A dysregulation in the signaling pathways involved in the regulation of muscle mass could play an important role in this phenomenon.
Hypothesis: Proteins involved in muscle mass regulation will be less activated in the quadriceps of patients with COPD following the acute bout of resistance training exercise compared to healthy age-matched controls.
Read the detailed description
Our objective is to investigate the impact of an acute bout of resistance training on key signaling pathways involved in the regulation of muscle mass in moderate to severe COPD (FEV1 under 60% of predicted). Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured before after 72 contractions of the quadriceps. The exercise protocol was designed to match the actual exercise prescription model use in the context of pulmonary rehabilitation. A squat, leg press and leg extension will be done at 80% of max with one minute rest between sets. A biopsy of the quadriceps will be done before and after exercise in order to measure phosphorylated kinases, total protein content and mRNA expressions. All our patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- exercise
- Keywords
- COPD, exercise training
- 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.
exerciseOther
resistance training exercise, 1 session, 3 exercises, 80% of max
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-exercise signaling proteins phosphorylation level in the quadriceps of COPD patients and age-matched healthy controls
Phosphorylation status of key proteins (Akt, p70, mTOR, p38, JNK, ERK) will be lesser modulated in the quadriceps of patients with COPD compare to healthy controls. The phosphorylated as well as the total protein levels will be measured by western blot. The data will be presented as arbitrary units and compared with values obtained in healthy age-matched healthy controls.
Measured: 2 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Bruno Lemire, Laval University
- Investigators
- François Maltais, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561625
- Sponsor's protocol ID
- SIM-COPD-20458
- Acronym
- SIM
- Status last verified
- May 2013
- First submitted
- 20 Mar 2012
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signaling Pathway Activation in the Quadriceps of Patients With COPD After an Acute Bout of Resistance
- ClinicalTrials.gov ID
- NCT01561625
- Acronym / sponsor ID
- SIM / SIM-COPD-20458
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Mar 2012 (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.
Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. A dysregulation in the signaling pathways involved in the regulation of muscle mass could play an important role in this phenomenon.
Hypothesis: Proteins involved in muscle mass regulation will be less activated in the quadriceps of patients with COPD following the acute bout of resistance training exercise compared to healthy age-matched controls.
Detailed description
Our objective is to investigate the impact of an acute bout of resistance training on key signaling pathways involved in the regulation of muscle mass in moderate to severe COPD (FEV1 under 60% of predicted). Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured before after 72 contractions of the quadriceps. The exercise protocol was designed to match the actual exercise prescription model use in the context of pulmonary rehabilitation. A squat, leg press and leg extension will be done at 80% of max with one minute rest between sets. A biopsy of the quadriceps will be done before and after exercise in order to measure phosphorylated kinases, total protein content and mRNA expressions. All our patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- COPD with an FEV1 of under 60% of predicted
- non-smoker
- Between 50 and 75 years old
Key exclusion criteria (7 listed)
- All inflammatory disease (HIV, Cancer, renal and cardiac deficiency)
- Hormonal dysregulation
- Inferior limb pathology
- Neuromuscular pathology
- History of tabacco or alcool abuse
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 |
|---|---|---|
| exerciseresistance training exercise, 1 session, 3 exercises, 80% of max | Other | – |
Primary outcome
Post-exercise signaling proteins phosphorylation level in the quadriceps of COPD patients and age-matched healthy controls
Time frame: 2 hours post-exercise
Phosphorylation status of key proteins (Akt, p70, mTOR, p38, JNK, ERK) will be lesser modulated in the quadriceps of patients with COPD compare to healthy controls. The phosphorylated as well as the total protein levels will be measured by western blot. The data will be presented as arbitrary units and compared with values obtained in healthy age-matched healthy controls.
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 7 May 2013.
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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.
François Maltais, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
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 4 inclusion and 7 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 7 May 2013. 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 Canada. 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?
Post-exercise signaling proteins phosphorylation level in the quadriceps of COPD patients and age-matched healthy controls (time frame: 2 hours post-exercise). 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 7 May 2013.