COPDPhase 3REWORKNCT01135966
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training
A Phase 3 study testing Conventional resistance training program and Whole body vibration resistance training program in people with COPD, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Conventional resistance training program and Whole body vibration resistance training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD candidate for pulmonary rehabilitation
- Men and female between 40 and 80 years of age
- Written informed consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- COPD
- Being tested
- Conventional resistance training program, Whole body vibration resistance training program
- Keywords
- COPD, Whole Body Vibration training, Conventional resistance training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional resistance training programBehavioural
Conventional resistance training program is followed.
Whole body vibration resistance training programBehavioural
WBV training on FITVIBE
| Study group | Role | What they receive |
|---|---|---|
| Conventional training | Active comparator | Not described Receives: Behavioral: Conventional resistance training program |
| Whole body vibration training | Experimental | Not described Receives: Behavioral: Whole body vibration resistance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and after 12 weeks
Secondary outcomes (7)
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.
Measured: before and after 12 weeks
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.
Measured: before and after 12 weeks
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
Measured: before and after 12 weeks
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
Measured: before and after 12 weeks
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
Measured: beforer and after 12 weeks
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.
Measured: 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
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.
Measured: before and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Derom, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135966
- Sponsor's protocol ID
- 2010/157
- Acronym
- REWORK
- Status last verified
- Dec 2011
- First submitted
- 2 Jun 2010
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26457458
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training
- ClinicalTrials.gov ID
- NCT01135966
- Acronym / sponsor ID
- REWORK / 2010/157
- Conditions
- COPD
- Keywords
- COPD, Whole Body Vibration training, Conventional resistance training
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional training | Active comparator | Behavioral: Conventional resistance training program |
| Whole body vibration training | Experimental | Behavioral: Whole body vibration resistance training program |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD candidate for pulmonary rehabilitation
- Men and female between 40 and 80 years of age
- Written informed consent to participate
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional resistance training programConventional resistance training program is followed. | Behavioural | Conventional training |
| Whole body vibration resistance training programWBV training on FITVIBE | Behavioural | Whole body vibration training |
Primary outcome
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
7 secondary outcomes
changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD
Time frame: 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
changes in maximal exercise capacity after CRT or after WBV training in patients with COPD
Time frame: 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
changes in Quality of life after CRT or after WBV training in patients with COPD
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- Derived from this study: PubMed 26457458Salhi 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.
- website of University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Derom, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional resistance training program and Whole body vibration resistance training program in people with COPD, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.