Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: COPD

• Registration Number: NCT00877084
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-12
• Study Completion: 2008-12
• Status Verified: 2009-04
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Last Update Submitted: 2009-04-06
• Study First Posted: 2009-04-07
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in the decline of muscle force during the exacerbation.	discharge Day 9

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitair Ziekenhuis Leuven, Campus Gasthuisberg; 🇧🇪 Leuven, Belgium