Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Other: Resistance training
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>* Other names: Usual care according to a clinical pathway + Resistance training;|
| Placebo Comparator: 2<br>Usual care according to clinical pathway for COPD exacerbations + NO training | Other: Usual care<br>* usual care according to clinical pathway for COPD, No training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the decline of muscle force during the exacerbation. |  | discharge Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to readmission or death |  | 6 Months | 
| Functional exercise capacity at discharge (6MWT) |  | discharge Day 9 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exacerbation, COPD, Resistance training, Muscle force