- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135966
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training (REWORK)
Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with chronic lung disease based on a growing body of scientific evidence. A set of evidence-based guidelines were published in American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the published literature in pulmonary rehabilitation has increased substantially, and other societies have published important statements about pulmonary rehabilitation (eg, the American Thoracic Society and the European Respiratory Society).
In patients with COPD, there is a strong scientific basis for implementing conventional resistance training (CRT) in addition to endurance training. Endurance training, such as walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance and muscular endurance. However, this type of training may not reverse muscle weakness or atrophy. For that reason, strength training seems to be the optimum training modality to increase muscle mass and strength.
Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for resistance training on multigym equipment. In WBV training, the subject stands on a platform that generates vertical sinusoidal vibration, during which static and dynamic exercises can be performed.
The present study is conducted to provide an answer on the following question: will a resistance training program, such as the whole body vibration, be even effective than a conventional resistance training program in patients with COPD.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium
- University Hospital Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with COPD candidate for pulmonary rehabilitation
- Men and female between 40 and 80 years of age
- Written informed consent to participate
Exclusion Criteria:
- Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training.
- Pacemaker
- Hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates
- Uncontrolled diabetes, epilepsy or migraine
- Osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole body vibration training
|
WBV training on FITVIBE
|
|
Active Comparator: Conventional training
|
Conventional resistance training program is followed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
estimation of the change of 6 MWD before and after 12 weeks resistance training program (CRT versus WBV training)
Time Frame: before and after 12 weeks
|
estimation of the change of 6 MWD (submaximal walking test)after a 12 week conventional resistance training program or after a 12 week whole body vibration training program
|
before and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by modified Microfet before and after 12 weeks of training.
|
before and after 12 weeks
|
|
changes in body composition after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by bioelectrical impedance analysis: Fat Free Mass (FFM)before and after 12 weeks of training.
|
before and after 12 weeks
|
|
changes in maximal exercise capacity after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by cyclo-ergospirometry before and after 12 weeks of training
|
before and after 12 weeks
|
|
changes in muscle force after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by handgrip force, maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax)before and after 12 weeks of training
|
before and after 12 weeks
|
|
changes in Quality of life after CRT or after WBV training in patients with COPD
Time Frame: beforer and after 12 weeks
|
measured by CRDQ (Chronic Respiratory Disease Questionnaire)before and after 12 weeks of training
|
beforer and after 12 weeks
|
|
changes in Dyspnea scores after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by Chronic Respiratory Disease Questionnaire domain dyspnea (CRDQd) and by the BORG scale before and after 12 weeks of training.
|
before and after 12 weeks
|
|
changes in 6MWD and the endurance test on the bicycle after CRT or after WBV training in patients with COPD
Time Frame: before and after 12 weeks
|
measured by endurance test on the bicycle (75% Max.
Workload)before and after 12 weeks of training.
This test will also be repeated after 6 weeks of training.
|
before and after 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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