Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00877084

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

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.

2

Usual care according to clinical pathway for COPD exacerbations + NO training

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

usual care according to clinical pathway for COPD, No training

Interventions

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.

Intervention Type: OTHER

Usual care

usual care according to clinical pathway for COPD, No training

Intervention Type: OTHER

Other Intervention Names

Usual care according to a clinical pathway + Resistance training

Eligibility Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Research Foundation Flanders

Locations

Universitair Ziekenhuis Leuven, Campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

References

Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, Gosselink R. Resistance training prevents deterioration in quadriceps muscle function during acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 May 15;181(10):1072-7. doi: 10.1164/rccm.200908-1203OC. Epub 2010 Feb 4.

Reference Type: DERIVED

PMID: 20133927 (View on PubMed)

Other Identifiers

1.5.139.06KAN

Identifier Type: -

Identifier Source: org_study_id