Chronic Obstructive Lung Disease (n=10)NCT01898143
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease
A study testing Whole body vibration in people with Chronic Obstructive Lung Disease (n=10) and Interstitial Lung Disease (n=10), run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Whole body vibration training seems to be a useful adjunct in exercise training in patients with severe COPD. The basic principle relies on reflectory muscle contractions caused by a vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary parameters remained unknown. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Obstructive Lung Disease (n=10), Interstitial Lung Disease (n=10)
- What is being tested?
- Whole body vibration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD])
- Interstitial Lung disease (forced vital capacity (FVC) < 70% pred., diffusion capacity of lung for carbon monoxide (DLCO) 30-70% pred.)
Who cannot join
- Oxygen therapy during exercise required
- Severe exacerbation of lung disease, with necessity of change in medication or persistent symptoms > 3days
- activated arthrosis /arthropathy/ rheumatoid Arthritis/ acute discopathy
- acute thrombosis
- acute musculoskeletal inflammation
- Epilepsy
- Gallstones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD)
Whole body vibration training seems to be a useful adjunct in exercise training in patients with severe COPD. The basic principle relies on reflectory muscle contractions caused by a vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary parameters during whole body vibration training in patients with chronic lung disease.
- Being tested
- Whole body vibration
- Keywords
- Whole body vibration, cardiorespiratory response
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationOther
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration in COPD | Other | Patients with COPD GOLD III or IV Receives: Other: Whole body vibration |
| Whole body vibration in ILD | Other | PAtients with interstitial lung disease Receives: Other: Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak oxygen consumption (VO2 peak)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
Secondary outcomes (6)
heart rate (HR)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
minute ventilation (VE)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
perceived exertion for dyspnea and leg fatigue (Borg-scale)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
Alveolar-arterial oxygen difference (AaDO2)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
breathing frequency (BF)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
peak carbon-dioxide consumption (VCO2 peak)
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
Measured: during 1 exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung Disease (n=10)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 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
- NCT01898143
- Sponsor's protocol ID
- SpiroErgoGalileo-2013
- Status last verified
- Feb 2016
- First submitted
- 24 Jun 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD)
- ClinicalTrials.gov ID
- NCT01898143
- Acronym / sponsor ID
- SpiroErgoGalileo-2013
- Keywords
- Whole body vibration, cardiorespiratory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jul 2013 (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.
Whole body vibration training seems to be a useful adjunct in exercise training in patients with severe COPD. The basic principle relies on reflectory muscle contractions caused by a vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary parameters during whole body vibration training in patients with chronic lung disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration in COPD | Other | Other: Whole body vibrationPatients with COPD GOLD III or IV |
| Whole body vibration in ILD | Other | Other: Whole body vibrationPAtients with interstitial lung disease |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD])
- Interstitial Lung disease (forced vital capacity (FVC) < 70% pred., diffusion capacity of lung for carbon monoxide (DLCO) 30-70% pred.)
Key exclusion criteria (7 listed)
- Oxygen therapy during exercise required
- Severe exacerbation of lung disease, with necessity of change in medication or persistent symptoms > 3days
- activated arthrosis /arthropathy/ rheumatoid Arthritis/ acute discopathy
- acute thrombosis
- acute musculoskeletal inflammation
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 | Other | Whole body vibration in COPD, Whole body vibration in ILD |
Primary outcome
peak oxygen consumption (VO2 peak)
Time frame: during 1 exercise session
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration. The peak values of each single part is used for comparison.
6 secondary outcomes
heart rate (HR)
Time frame: during 1 exercise session
minute ventilation (VE)
Time frame: during 1 exercise session
perceived exertion for dyspnea and leg fatigue (Borg-scale)
Time frame: during 1 exercise session
Alveolar-arterial oxygen difference (AaDO2)
Time frame: during 1 exercise session
breathing frequency (BF)
Time frame: during 1 exercise session
peak carbon-dioxide consumption (VCO2 peak)
Time frame: during 1 exercise session
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 24 Feb 2016.
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 in people with Chronic Obstructive Lung Disease (n=10) and Interstitial Lung Disease (n=10), 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 2 inclusion and 7 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 24 Feb 2016. 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?
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?
peak oxygen consumption (VO2 peak) (time frame: during 1 exercise session). 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 24 Feb 2016.