Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease

NCT00877084 | Completed

• 1 other identifier: 1.5.139.06KAN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

exacerbation; COPD; Resistance training; Muscle force

Outcome Measures

Primary Outcomes (1)

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

  discharge Day 9

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Other: Usual care

Interventions

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.

Also known as: Usual care according to a clinical pathway + Resistance training

1

Usual care OTHER

usual care according to clinical pathway for COPD, No training

2

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD exacerbation, admitted to the respiratory units
• Informed consent
• Age \< 80
• No critical comorbidity compromising outcome up to one month.
• No suspect of malignancy

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Universitair Ziekenhuis Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 20133927 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: January 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2008
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

BE (1)