Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— EXTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877084
• Other study ID #: 1.5.139.06KAN
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: April 6, 2009
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion criteria:

• COPD exacerbation, admitted to the respiratory units

• Informed consent

• Age < 80

• No critical comorbidity compromising outcome up to one month.

• No suspect of malignancy

Exclusion criteria:

• Patient is involved in a rehabilitation program with a frequency >1/wk during one month after inclusion in the study

• NIMV or ICU on admission

• Patient scheduled for procedure (LTX/LVRS) within one month after discharge

• Readmission <14 days after previous hospitalization

• Significant pathology that would hinder the participation in resistance training (gonarthrosis, arthritis to be judged by the investigator)

• Clinical signs of pulmonary hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Resistance training
Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion. The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
• Usual care
usual care according to clinical pathway for COPD, No training

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven, Campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the decline of muscle force during the exacerbation.		discharge Day 9	No
Secondary	Time to readmission or death		6 Months	No
Secondary	Functional exercise capacity at discharge (6MWT)		discharge Day 9	No
Secondary	Functional exercise capacity and muscle force at 1 month		1 Month	No
Secondary	Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.		Day 9	Yes