Comparison of Repetitive Magnetic Stimulation (rMS) and Exercise Versus no Active Treatment on Quadriceps Function in Chronic Obstructive Pulmonary Disease (COPD)
|ClinicalTrials.gov Identifier: NCT00737698|
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : February 19, 2016
Background Chronic Obstructive Pulmonary Disease (COPD) patients develop leg weakness and a reduced walking capacity, due to reduced leg muscle oxygen-utilising capacity (OUC). Animal experiments indicate that low muscle levels of Peroxisome Proliferator-Activated Receptors (PPAR) cause the reduced muscle OUC.
In COPD patients, investigate whether:
- reduced muscle PPAR levels cause reduced leg muscle OUC, by investigating a correlation between these in muscle samples (Study 1).
- training increases muscle PPAR levels in proportion to increases in OUC, as should occur if PPARs control OUC (Study 2).
- muscle PPAR levels and walking capacity correlate (Study 1 and 2).
3. the new technique of repetitive stimulation of the nerve to the leg with a magnet (rMS) improves muscle OUC (Study 2).
Study 1 Leg weakness and walking ability are assessed in 75 patients, then a leg muscle sample is taken to measure PPARs and OUC.
Study 2 60 Study 1 patients have either cardiovascular training, rMS, or no training, for 8 weeks, then are re-studied as in Study 1.
Importance If reduced PPAR levels correspond with leg weakness, medicines can be developed to target these receptors and treat weakness. If rMS is effective, it can be offered to patients.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Exercise Other: Repetitive magnetic stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Is the Anaerobic Quadriceps Muscle Phenotype in Chronic Obstructive Pulmonary Disease Mediated by Reduced Muscle Concentrations of Peroxisome Proliferator-Activated Receptors Alpha and Delta?|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2010|
Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
Repetitive magnetic stimulation
Other: Repetitive magnetic stimulation
Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
No Intervention: 3
No active treatment
- Change in muscle Peroxisome Proliferator-Activated Receptor mRNA and protein levels [ Time Frame: 8 weeks ]
- Change in muscle strength and endurance, and exercise performance [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737698
|Respiratory Muscle Lab, Royal Brompton Hospital, Fulham Road|
|London, United Kingdom, SW3 6NP|
|Study Director:||Michael I Polkey, MBBS FRCP PhD||Royal Brompton Hospital/Imperial College|
|Principal Investigator:||Samantha A Sathyapala, MA BMBCH MRCP||Imperial College London|