Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease (EXTRA)

This study has been completed.
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00877084
First received: April 6, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
COPD
Other: Resistance training
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Reduction in the decline of muscle force during the exacerbation. [ Time Frame: discharge Day 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to readmission or death [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Functional exercise capacity at discharge (6MWT) [ Time Frame: discharge Day 9 ] [ Designated as safety issue: No ]
  • Functional exercise capacity and muscle force at 1 month [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
  • Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation. [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Usual care according to a clinical pathway + Resistance training
Placebo Comparator: 2
Usual care according to clinical pathway for COPD exacerbations + NO training
Other: Usual care
usual care according to clinical pathway for COPD, No training

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00877084

Locations
Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

No publications provided by Katholieke Universiteit Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fonds voor Wetenschappelijk Onderzoek-Vlaanderen, Research Foundation Flanders
ClinicalTrials.gov Identifier: NCT00877084     History of Changes
Other Study ID Numbers: 1.5.139.06KAN
Study First Received: April 6, 2009
Last Updated: April 6, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
exacerbation
COPD
Resistance training
Muscle force

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014