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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01091623
Other study ID # 001/2005
Secondary ID
Status Completed
Phase N/A
First received March 23, 2010
Last updated March 23, 2010
Start date June 2005

Study information

Verified date May 2005
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethic Comittee, Vienna, Mediacl University
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date
Est. primary completion date January 2010
Accepts healthy volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

1. age: 40-75 years

2. mild to moderate COPD patients according to the staging schemata of the austrian society of lung and tuberculosis disease (ÖGLUT)

Exclusion Criteria:

1. acute infection

2. reduced left ventricular function

3. myocardial infarction

4. stroke

5. severe pulmonary hypertension (mpap>40mmHg)

6. insufficient treated hypertension RR>160/95) (participation with sufficient treatment )

7. severe cardiac arrhythmia

8. malignant diseases

9. severe osteoporosis

10. nicotine abuses

11. other severe chronic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
training

training

training


Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary increase of exercise capacity
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