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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)

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
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Other: Exercise
Other: Repetitive magnetic stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in muscle Peroxisome Proliferator-Activated Receptor mRNA and protein levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in muscle strength and endurance, and exercise performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: January 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Samantha Amanda Sathyapala, Imperial College London
ClinicalTrials.gov Identifier: NCT00737698     History of Changes
Other Study ID Numbers: rMS v exercise in COPD
Study First Received: August 18, 2008
Last Updated: August 18, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on November 25, 2014