Comparison of Repetitive Magnetic Stimulation (rMS) and Exercise Versus no Active Treatment on Quadriceps Function in Chronic Obstructive Pulmonary Disease (COPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Wellcome Trust
Maastricht University
Magstim Company, Whitland, Wales
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00737698
First received: August 18, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

August 18, 2008
August 18, 2008
January 2007
October 2008   (final data collection date for primary outcome measure)
Change in muscle Peroxisome Proliferator-Activated Receptor mRNA and protein levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Change in muscle strength and endurance, and exercise performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Repetitive Magnetic Stimulation (rMS) and Exercise Versus no Active Treatment on Quadriceps Function in Chronic Obstructive Pulmonary Disease (COPD)
Is the Anaerobic Quadriceps Muscle Phenotype in Chronic Obstructive Pulmonary Disease Mediated by Reduced Muscle Concentrations of Peroxisome Proliferator-Activated Receptors Alpha and Delta?

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.

Aims

In COPD patients, investigate whether:

  1. reduced muscle PPAR levels cause reduced leg muscle OUC, by investigating a correlation between these in muscle samples (Study 1).
  2. training increases muscle PPAR levels in proportion to increases in OUC, as should occur if PPARs control OUC (Study 2).
  3. 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chronic Obstructive Pulmonary Disease
  • Other: Exercise
    Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
  • Other: Repetitive magnetic stimulation
    Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
  • Experimental: 1
    Exercise
    Intervention: Other: Exercise
  • Experimental: 2
    Repetitive magnetic stimulation
    Intervention: Other: Repetitive magnetic stimulation
  • No Intervention: 3
    No active treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
October 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

  • Cardiac failure
  • Renal failure
  • Liver failure
  • Diabetes mellitus
  • Systemic inflammatory diseases eg Rheumatoid arthritis, SLE
  • Warfarin, coagulation problems
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00737698
rMS v exercise in COPD
No
Dr Samantha Amanda Sathyapala, Imperial College London
Imperial College London
  • Wellcome Trust
  • Maastricht University
  • Magstim Company, Whitland, Wales
Study Director: Michael I Polkey, MBBS FRCP PhD Royal Brompton Hospital/Imperial College
Imperial College London
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP