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Clinical Trials/NCT00877084
NCT00877084
Completed
Not Applicable

Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD

KU Leuven1 site in 1 country40 target enrollmentJanuary 2004
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
KU Leuven
Enrollment
40
Locations
1
Primary Endpoint
Reduction in the decline of muscle force during the exacerbation.
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.

The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.

After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Reduction in the decline of muscle force during the exacerbation.

Time Frame: discharge Day 9

Secondary Outcomes

  • Functional exercise capacity at discharge (6MWT)(discharge Day 9)
  • Time to readmission or death(6 Months)
  • Functional exercise capacity and muscle force at 1 month(1 Month)
  • Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.(Day 9)

Study Sites (1)

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