COPDEXTRANCT00877084
Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease
A study testing Resistance training in people with COPD, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD exacerbation, admitted to the respiratory units
- Informed consent
- Age < 80
- No critical comorbidity compromising outcome up to one month.
- No suspect of malignancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, 3000
About this study
Official title: Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
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
- Being tested
- Resistance training, Usual care
- Keywords
- exacerbation, COPD, Resistance training, Muscle force
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Also called Usual care according to a clinical pathway + 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.
Usual careOther
usual care according to clinical pathway for COPD, No training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Resistance training |
| 2 | Placebo comparator | Usual care according to clinical pathway for COPD exacerbations + NO training Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the decline of muscle force during the exacerbation.
Measured: discharge Day 9
Secondary outcomes (4)
Time to readmission or death
Measured: 6 Months
Functional exercise capacity at discharge (6MWT)
Measured: discharge Day 9
Functional exercise capacity and muscle force at 1 month
Measured: 1 Month
Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877084
- Sponsor's protocol ID
- 1.5.139.06KAN
- Acronym
- EXTRA
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20133927
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT00877084
- Acronym / sponsor ID
- EXTRA / 1.5.139.06KAN
- Conditions
- COPD
- Keywords
- exacerbation, COPD, Resistance training, Muscle force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Resistance trainingResistance 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 | Placebo comparator | Other: Usual careUsual care according to clinical pathway for COPD exacerbations + NO training |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- COPD exacerbation, admitted to the respiratory units
- Informed consent
- Age < 80
- No critical comorbidity compromising outcome up to one month.
- No suspect of malignancy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingAlso: Usual care according to a clinical pathway + Resistance trainingResistance 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 | 1 |
| Usual careusual care according to clinical pathway for COPD, No training | Other | 2 |
Primary outcome
Reduction in the decline of muscle force during the exacerbation.
Time frame: discharge Day 9
4 secondary outcomes
Time to readmission or death
Time frame: 6 Months
Functional exercise capacity at discharge (6MWT)
Time frame: discharge Day 9
Functional exercise capacity and muscle force at 1 month
Time frame: 1 Month
Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.
Time frame: Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
- Derived from this study: PubMed 20133927Troosters 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with COPD, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the decline of muscle force during the exacerbation. (time frame: discharge Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.