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

Primary Purpose

COPD

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Conventional resistance training program
Whole body vibration resistance training program
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Whole Body Vibration training, Conventional resistance training

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional training

Whole body vibration training

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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
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
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.
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.

Full Information

First Posted
June 2, 2010
Last Updated
December 9, 2011
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01135966
Brief Title
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training
Acronym
REWORK
Official Title
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Whole Body Vibration training, Conventional resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional training
Arm Type
Active Comparator
Arm Title
Whole body vibration training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Conventional resistance training program
Intervention Description
Conventional resistance training program is followed.
Intervention Type
Behavioral
Intervention Name(s)
Whole body vibration resistance training program
Intervention Description
WBV training on FITVIBE
Primary Outcome Measure Information:
Title
estimation of the change of 6 MWD before and after 12 weeks resistance training program (CRT versus WBV training)
Description
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
Time Frame
before and after 12 weeks
Secondary Outcome Measure Information:
Title
changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD
Description
measured by modified Microfet before and after 12 weeks of training.
Time Frame
before and after 12 weeks
Title
changes in body composition after CRT or after WBV training in patients with COPD
Description
measured by bioelectrical impedance analysis: Fat Free Mass (FFM)before and after 12 weeks of training.
Time Frame
before and after 12 weeks
Title
changes in maximal exercise capacity after CRT or after WBV training in patients with COPD
Description
measured by cyclo-ergospirometry before and after 12 weeks of training
Time Frame
before and after 12 weeks
Title
changes in muscle force after CRT or after WBV training in patients with COPD
Description
measured by handgrip force, maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax)before and after 12 weeks of training
Time Frame
before and after 12 weeks
Title
changes in Quality of life after CRT or after WBV training in patients with COPD
Description
measured by CRDQ (Chronic Respiratory Disease Questionnaire)before and after 12 weeks of training
Time Frame
beforer and after 12 weeks
Title
changes in Dyspnea scores after CRT or after WBV training in patients with COPD
Description
measured by Chronic Respiratory Disease Questionnaire domain dyspnea (CRDQd) and by the BORG scale before and after 12 weeks of training.
Time Frame
before and after 12 weeks
Title
changes in 6MWD and the endurance test on the bicycle after CRT or after WBV training in patients with COPD
Description
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.
Time Frame
before and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Derom, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26457458
Citation
Salhi B, Malfait TJ, Van Maele G, Joos G, van Meerbeeck JP, Derom E. Effects of Whole Body Vibration in Patients With COPD. COPD. 2015;12(5):525-32. doi: 10.3109/15412555.2015.1008693. Epub 2015 Aug 4.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
website of University Hospital Ghent

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

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