Chronic Obstructive Pulmonary DiseaseNCT01380639
Effects of Vibration Training on Exercise Capacity in COPD-patients
A study testing whole body vibration training in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- whole body vibration training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease III/IV
Who cannot join
- Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
- Severe disease other than COPD, that could influence the results of the study
- Abuse of alcohol or drugs
- Simultaneously participation in another study
- Tachypnea (>30/min)
- Severe exacerbation during rehabilitation
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- Cardiac insufficiency (NYHA IV)
- Myocardial infarction during the last 6 weeks
- Mental-health problem
- Pregnancy
- Known HIV-infection
- Slipped disk
- Acute discopathy
- Acute thrombosis
- Implants in trained regions of the body (lower extremities)
- Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
- Acute tendinopathy in trained regions of the body
- Acute hernia
- Fresh fractures, wounds or scars in trained regions of the body
- Gallstones or stones in the urinary tract collection system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vibration Training During a Three-week Rehabilitation on Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients
The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- whole body vibration training
- Keywords
- COPD III/IV, 6-Minutes-Walking-Distance, Vibration training, Galileo, Pulmonary rehabilitation
- 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.
whole body vibration trainingOther
performing squats for 3x3 minutes while using vibration platform three times a week
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with vibration training | Experimental | Not described Receives: Other: whole body vibration training |
| Rehabilitation without vibration training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute-Walking-Distance
Change in 6-minute-walking-distance from baseline to day 19
Measured: day 1, day 19
Secondary outcomes (6)
Body Composition
Change in body composition from baseline to day 19
Measured: day 1 and 19
Isometric Maximum Handgrip Force
change in isometric max. handgrip force from baseline to day 19
Measured: day 1, day 19
BODE-Score
Change in Bode-Score from baseline to day 19
Measured: day 1, day 19
Lung Function
Measured: day 1
Arterial Blood Gas
Measured: day 1
Brain Natruretic Peptide (BNP)
change in BNP from baseline to day 19
Measured: day 1, day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380639
- Sponsor's protocol ID
- BGL-Ga-6MGT-0810
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2011
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Training During a Three-week Rehabilitation on Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients
- ClinicalTrials.gov ID
- NCT01380639
- Acronym / sponsor ID
- BGL-Ga-6MGT-0810
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD III/IV, 6-Minutes-Walking-Distance, Vibration training, Galileo, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 28 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with vibration training | Experimental | Other: whole body vibration training |
| Rehabilitation without vibration training | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic obstructive pulmonary disease III/IV
Key exclusion criteria (20 listed)
- Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
- Severe disease other than COPD, that could influence the results of the study
- Abuse of alcohol or drugs
- Simultaneously participation in another study
- Tachypnea (>30/min)
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 |
|---|---|---|
| whole body vibration trainingperforming squats for 3x3 minutes while using vibration platform three times a week | Other | Rehabilitation with vibration training |
Primary outcome
6-Minute-Walking-Distance
Time frame: day 1, day 19
Change in 6-minute-walking-distance from baseline to day 19
6 secondary outcomes
Body Composition
Time frame: day 1 and 19
Isometric Maximum Handgrip Force
Time frame: day 1, day 19
BODE-Score
Time frame: day 1, day 19
Lung Function
Time frame: day 1
Arterial Blood Gas
Time frame: day 1
Brain Natruretic Peptide (BNP)
Time frame: day 1, day 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration training in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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 1 inclusion and 20 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 30 Apr 2019. 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 Germany. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6-Minute-Walking-Distance (time frame: day 1, day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2019.