Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training (REWORK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01135966
First received: June 2, 2010
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
COPD
Behavioral: Conventional resistance training program
Behavioral: Whole body vibration resistance training program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    measured by modified Microfet before and after 12 weeks of training.

  • changes in body composition after CRT or after WBV training in patients with COPD [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    measured by bioelectrical impedance analysis: Fat Free Mass (FFM)before and after 12 weeks of training.

  • changes in maximal exercise capacity after CRT or after WBV training in patients with COPD [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    measured by cyclo-ergospirometry before and after 12 weeks of training

  • changes in muscle force after CRT or after WBV training in patients with COPD [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    measured by handgrip force, maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax)before and after 12 weeks of training

  • changes in Quality of life after CRT or after WBV training in patients with COPD [ Time Frame: beforer and after 12 weeks ] [ Designated as safety issue: No ]
    measured by CRDQ (Chronic Respiratory Disease Questionnaire)before and after 12 weeks of training

  • changes in Dyspnea scores after CRT or after WBV training in patients with COPD [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    measured by Chronic Respiratory Disease Questionnaire domain dyspnea (CRDQd) and by the BORG scale before and after 12 weeks of training.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional training Behavioral: Conventional resistance training program
Conventional resistance training program is followed.
Experimental: Whole body vibration training Behavioral: Whole body vibration resistance training program
WBV training on FITVIBE

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135966

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Eric Derom, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01135966     History of Changes
Other Study ID Numbers: 2010/157
Study First Received: June 2, 2010
Last Updated: December 9, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
COPD
Whole Body Vibration training
Conventional resistance training

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014