Chronic Obstructive Pulmonary DiseaseNCT01091623
Effects of Strength Training in Combination With Endurance Training on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing training in people with Chronic Obstructive Pulmonary Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background. Exercise intolerance is one of the most devastating consequences of chronic obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as weakness and reduction in oxidative enzyme activities are commonly found in these patients and may contribute to exercise intolerance.To… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2005to Jan 2010
- 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 40 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- age: 40-75 years
- mild to moderate COPD patients according to the staging schemata of the austrian society of lung and tuberculosis disease (ÖGLUT)
Who cannot join
- acute infection
- reduced left ventricular function
- myocardial infarction
- stroke
- severe pulmonary hypertension (mpap>40mmHg)
- insufficient treated hypertension RR>160/95) (participation with sufficient treatment )
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- severe cardiac arrhythmia
- malignant diseases
- severe osteoporosis
- nicotine abuses
- other severe chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Background. Exercise intolerance is one of the most devastating consequences of chronic obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as weakness and reduction in oxidative enzyme activities are commonly found in these patients and may contribute to exercise intolerance.To evaluate whether a systemic weightlifting exercise may improve exercise capacity better than endurance training, or a combined training is more effective, the investigators compared three different training regimens, endurance training alone, systemic weightlifting training alone or a combination of both endurance and weightlifting training.
Methods.36 patients with stable COPD will be evaluated before and after a 4 month training program. Each evaluation include a stepwise exercise test on an ergocycle up to the individual maximal capacity during which minute ventilation (VE), oxygen consumption (VO2), carbon dioxide production (VCO2), and arterial lactic acid concentration will be measured and the peripheral muscle strength will be determined with the one repetition maximum for eight different muscle groups. Percutaneous needle muscle biopsy from the M.vastus lateralis will be performed before and after the training period in order to determine the fiber-type proportions. Patients are assigned to one of the following three groups (1) endurance training consisted of 20 min exercise sessions on a calibrated ergocycle two times a week, with a target training intensity at 60% of individual maximum oxygen uptake, (2) systemic weightlifting training two times a week with eight different exercises, each session consist of 15 repetitions of each muscle group, (3) combination of endurance training and systemic weightlifting training.
Statistical analysis. Baseline data for all patients enrolled in the study will be compared by one-way analysis of variance for the three study groups. Results before and after training will be analyzed by two- way analysis of variance.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- training
- Keywords
- improvement of exercise capacity in patients with COPD
- 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.
trainingOther
trainingOther
trainingOther
| Study group | Role | What they receive |
|---|---|---|
| strength training | Active comparator | Not described Receives: Other: training |
| endurance training | Active comparator | Not described Receives: Other: training |
| combined training | Active comparator | Not described Receives: Other: training |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase of exercise capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJun 2005
- Primary completionJan 2010
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 Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091623
- Sponsor's protocol ID
- 001/2005
- Status last verified
- May 2005
- First submitted
- 23 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
Publications
Vonbank K, Strasser B, Mondrzyk J, Marzluf BA, Richter B, Losch S, Nell H, Petkov V, Haber P. Strength training increases maximum working capacity in patients with COPD--randomized clinical trial comparing three training modalities. Respir Med. 2012 Apr;106(4):557-63. doi: 10.1016/j.rmed.2011.11.005. Epub 2011 Nov 26.
PubMed 22119456
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training in Combination With Endurance Training on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01091623
- Acronym / sponsor ID
- 001/2005
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- improvement of exercise capacity in patients with COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2010 (actual)
- First posted
- 24 Mar 2010 (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.
Background. Exercise intolerance is one of the most devastating consequences of chronic obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as weakness and reduction in oxidative enzyme activities are commonly found in these patients and may contribute to exercise intolerance.To evaluate whether a systemic weightlifting exercise may improve exercise capacity better than endurance training, or a combined training is more effective, the investigators compared three different training regimens, endurance training alone, systemic weightlifting training alone or a combination of both endurance and weightlifting training.
Methods.36 patients with stable COPD will be evaluated before and after a 4 month training program. Each evaluation include a stepwise exercise test on an ergocycle up to the individual maximal capacity during which minute ventilation (VE), oxygen consumption (VO2), carbon dioxide production (VCO2), and arterial lactic acid concentration will be measured and the peripheral muscle strength will be determined with the one repetition maximum for eight different muscle groups. Percutaneous needle muscle biopsy from the M.vastus lateralis will be performed before and after the training period in order to determine the fiber-type proportions. Patients are assigned to one of the following three groups (1) endurance training consisted of 20 min exercise sessions on a calibrated ergocycle two times a week, with a target training intensity at 60% of individual maximum oxygen uptake, (2) systemic weightlifting training two times a week with eight different exercises, each session consist of 15 repetitions of each muscle group, (3) combination of endurance training and systemic weightlifting training.
Statistical analysis. Baseline data for all patients enrolled in the study will be compared by one-way analysis of variance for the three study groups. Results before and after training will be analyzed by two- way analysis of variance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| strength training | Active comparator | Other: training |
| endurance training | Active comparator | Other: training |
| combined training | Active comparator | Other: training |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age: 40-75 years
- mild to moderate COPD patients according to the staging schemata of the austrian society of lung and tuberculosis disease (ÖGLUT)
Key exclusion criteria (11 listed)
- acute infection
- reduced left ventricular function
- myocardial infarction
- stroke
- severe pulmonary hypertension (mpap>40mmHg)
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 |
|---|---|---|
| training | Other | strength training |
| training | Other | endurance training |
| training | Other | combined training |
Primary outcome
increase of exercise capacity
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 24 Mar 2010.
- Derived from this study: PubMed 22119456Vonbank K, Strasser B, Mondrzyk J, Marzluf BA, Richter B, Losch S, Nell H, Petkov V, Haber P. Strength training increases maximum working capacity in patients with COPD--randomized clinical trial comparing three training modalities. Respir Med. 2012 Apr;106(4):557-63. doi: 10.1016/j.rmed.2011.11.005. Epub 2011 Nov 26.
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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 training in people with Chronic Obstructive Pulmonary Disease, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 11 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 24 Mar 2010. 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 Austria. 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. 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?
increase of exercise capacity. 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 NCT01091623, 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 24 Mar 2010.