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

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ClinicalTrials.gov Identifier: NCT00737698
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : February 19, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Exercise Other: Repetitive magnetic stimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
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
Primary Completion Date : October 2008
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Exercise
Other: Exercise
Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
Experimental: 2
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


Outcome Measures

Primary Outcome Measures :
  1. Change in muscle Peroxisome Proliferator-Activated Receptor mRNA and protein levels [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in muscle strength and endurance, and exercise performance [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737698


Locations
United Kingdom
Respiratory Muscle Lab, Royal Brompton Hospital, Fulham Road
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Maastricht University
Magstim Company, Whitland, Wales
Investigators
Study Director: Michael I Polkey, MBBS FRCP PhD Royal Brompton Hospital/Imperial College
Principal Investigator: Samantha A Sathyapala, MA BMBCH MRCP Imperial College London
More Information

Responsible Party: Amanda Sathyapala, Wellcome Trust Clinical Research Fellow, Imperial College London
ClinicalTrials.gov Identifier: NCT00737698     History of Changes
Other Study ID Numbers: rMS v exercise in COPD
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: August 2008

Keywords provided by Amanda Sathyapala, Imperial College London:
COPD
exercise
repetitive magnetic stimulation
quadriceps strength

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases