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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01135966
Other study ID # 2010/157
Secondary ID
Status Completed
Phase Phase 3
First received June 2, 2010
Last updated December 9, 2011
Start date April 2010
Est. completion date November 2011

Study information

Verified date December 2011
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date November 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Conventional resistance training program
Conventional resistance training program is followed.
Whole body vibration resistance training program
WBV training on FITVIBE

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary estimation of the change of 6 MWD before and after 12 weeks resistance training program (CRT versus WBV training) 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 Yes
Secondary changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD measured by modified Microfet before and after 12 weeks of training. before and after 12 weeks No
Secondary changes in body composition after CRT or after WBV training in patients with COPD measured by bioelectrical impedance analysis: Fat Free Mass (FFM)before and after 12 weeks of training. before and after 12 weeks No
Secondary changes in maximal exercise capacity after CRT or after WBV training in patients with COPD measured by cyclo-ergospirometry before and after 12 weeks of training before and after 12 weeks No
Secondary changes in muscle force after CRT or after WBV training in patients with COPD 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 No
Secondary changes in Quality of life after CRT or after WBV training in patients with COPD measured by CRDQ (Chronic Respiratory Disease Questionnaire)before and after 12 weeks of training beforer and after 12 weeks No
Secondary changes in Dyspnea scores after CRT or after WBV training in patients with COPD 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 No
Secondary changes in 6MWD and the endurance test on the bicycle after CRT or after WBV training in patients with COPD 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 No
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