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Completed

NCT Number: NCT00877084

Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

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.

Other names: Usual care according to a clinical pathway + Resistance training

Usual Care

Other

usual care according to clinical pathway for COPD, No training

Primary outcomes

  1. Reduction in the decline of muscle force during the exacerbation.

    Time frame: discharge Day 9

Secondary outcomes

  1. Time to readmission or death

    Time frame: 6 Months

  2. Functional exercise capacity at discharge (6MWT)

    Time frame: discharge Day 9

  3. Functional exercise capacity and muscle force at 1 month

    Time frame: 1 Month

  4. Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.

    Time frame: Day 9

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: EXTRA

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Apr 7, 2009
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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