COPDNCT02679677
Evaluation of the Effects of Whole Body Vibration on the Lung Function of Patients With Stable COPD
A study testing Whole Body Vibration in people with COPD, run by Heidelberg University at 2 sites in Germany.
Trial summary
The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Whole Body Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2015to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD (Gold II-IV)
- Signed understanding of participation
- The patients must be able to understand and follow the requirements of participation (Understanding of the German language)
Who cannot join
- Acute thrombosis
- Hemoptysis
- Implants in the targeted training regions (joint implants)
- Acute joint inflammation, active arthrosis or arthropathy.
- Rheumatoid arthritis
- Acute tendinopathy in the targeted training regions
Show all 18Show fewer
- Acute hernia
- Acute discopathy
- Fresh fracture in the targeted training regions
- Gall or kidney stones
- Wounds still in the process of healing
- Epilepsy
- Severe neurologic disorders (apoplexy, paralysis of upper and lower extremities)
- Severe circulatory disorders (Cardiac insufficiency NYHA > or = III, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope)
- Tension pneumothorax
- Acute internal bleeding
- Current therapy with fluoroquinolone
- Alcohol/drug/medication abuse
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Thoraxklinik at Heidelberg University Hospital
Heidelberg, 69126
University Clinic Gießen and Marburg GmbH, Marburg Campus
Marburg, 35033
About this study
Official title: Evaluation of the Effects of Whole Body Vibration Training With the Galileo Training Device on the Lung Function of Patients With Stable COPD
The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking.
The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.
- Conditions
- COPD
- Being tested
- Whole Body Vibration
- Keywords
- Chronic obstructive pulmonary disease, Randomized controlled trial, Physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationDevice
Also called Galileo, Galileo Platform Novotec Medical
The principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks. Receives: Device: Whole Body Vibration |
| Intervention | Experimental | Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks. Receives: Device: Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Secondary outcomes (10)
SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
mMRC: Modified British Medical Research Council
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
CAT: COPD Assessment Test
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
PHQ-9 (Brief Patient Health Questionnaire
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
SF-12: Short Form (12) Health Questionnaire
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
6 Minute Walking Test
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Chair Rising Test
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Handheld Dynamometry Strength Testing of Extremities
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Diffusion capacity for oxygen
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Maximal inspiratory pressure
Measured: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Felix Herth, Prof. Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679677
- Sponsor's protocol ID
- S-607/2014
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2016
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Whole Body Vibration Training With the Galileo Training Device on the Lung Function of Patients With Stable COPD
- ClinicalTrials.gov ID
- NCT02679677
- Acronym / sponsor ID
- S-607/2014
- Conditions
- COPD
- Keywords
- Chronic obstructive pulmonary disease, Randomized controlled trial, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Feb 2016 (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.
The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking.
The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Whole Body VibrationWhole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks. |
| Intervention | Experimental | Device: Whole Body VibrationWhole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable COPD (Gold II-IV)
- Signed understanding of participation
- The patients must be able to understand and follow the requirements of participation (Understanding of the German language)
Key exclusion criteria (18 listed)
- Acute thrombosis
- Hemoptysis
- Implants in the targeted training regions (joint implants)
- Acute joint inflammation, active arthrosis or arthropathy.
- Rheumatoid arthritis
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 VibrationAlso: Galileo, Galileo Platform Novotec MedicalThe principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz. | Device | Control, Intervention |
Primary outcome
FEV1
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
10 secondary outcomes
SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
mMRC: Modified British Medical Research Council
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
CAT: COPD Assessment Test
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
PHQ-9 (Brief Patient Health Questionnaire
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
SF-12: Short Form (12) Health Questionnaire
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
6 Minute Walking Test
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Chair Rising Test
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Handheld Dynamometry Strength Testing of Extremities
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Diffusion capacity for oxygen
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
Maximal inspiratory pressure
Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)
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 2 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
Felix Herth, Prof. Dr. med. principal investigator
University Hospital Heidelberg
2 sites 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 COPD, run by Heidelberg University at 2 sites 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 3 inclusion and 18 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
FEV1 (time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)). 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 2 Sep 2022.