Chronic Obstructive Pulmonary DiseaseNCT03157986
Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
A study testing Balance Training on a vibration platform and Conventional Balance training in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Balance Training on a vibration platform and Conventional Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2017to 16 Aug 2019
- 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 50 to 80 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
- impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.)
Who cannot join
- current acute exacerbation of COPD
- carbon dioxide pressure of more than 45 mmHg at rest
- any contraindication for vibration Training (e.g. acute deep vein thrombosis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
About this study
Official title: Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Balance Training on a vibration platform, Conventional Balance training
- Keywords
- COPD, Balance, Whole Body Vibration Training, pulmonary rehabilitation, exercise
- 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.
Balance Training on a vibration platformOther
n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz.
Conventional Balance trainingOther
n=24 patients with COPD, Exercises will be performed on a Balance pad
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration training | Active comparator | Balance Training on a Vibration platform Receives: Other: Balance Training on a vibration platform |
| Conventional Balance training | Active comparator | Balance Training on a Balance board Receives: Other: Conventional Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Balance Performance during semi Tandem stance
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Measured: measurement on Day 1 and 21
Secondary outcomes (11)
Change in muscle power during counter movement jump
patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight
Measured: measurement on Day 1 and 21
Change in performance of the 5-Repetition-Raise-Test
Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible
Measured: measurement on Day 1 and 21
Change in performance of the 1-Minute-Chair-Rise-Test
Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute
Measured: measurement on Day 1 and 21
Change in Peak muscle strength of the knee Extension muscles
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Measured: measurement on Day 1 and 21
Change in Peak muscle strength of the knee Flexion muscles
isometric peak torque of the knee flexor muscles are measured in 90° knee angle
Measured: measurement on Day 1 and 21
Change in 6-minute Walk Distance
patients are advised to walk as far as possible on a 30m track
Measured: measurement on Day 1 and 21
Change in 4m Gait Speed Test
patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.
Measured: measurement on Day 1 and 21
Change in step symmetry during 20m walking
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis
Measured: measurement on Day 1 and 21
Change in Hospital anxiety and Depression scale
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
Measured: measurement on Day 1 and 21
Change in balance performance during Romberg stance
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Measured: measurement on Day 1 and 21
Change in Balance Performance during 1-leg stance
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
Measured: measurement on Day 1 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 May 2017
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
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 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 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
- Investigators
- Klaus Kenn, MD, Principal investigator, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157986
- Sponsor's protocol ID
- WBVT Balance Study
- Status last verified
- Dec 2019
- First submitted
- 16 May 2017
- Last updated
- 24 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gloeckl R, Schneeberger T, Leitl D, Reinold T, Nell C, Jarosch I, Kenn K, Koczulla AR. Whole-body vibration training versus conventional balance training in patients with severe COPD-a randomized, controlled trial. Respir Res. 2021 May 4;22(1):138. doi: 10.1186/s12931-021-01688-x.
PubMed 33947416
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03157986
- Acronym / sponsor ID
- WBVT Balance Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Balance, Whole Body Vibration Training, pulmonary rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration training | Active comparator | Other: Balance Training on a vibration platformBalance Training on a Vibration platform |
| Conventional Balance training | Active comparator | Other: Conventional Balance trainingBalance Training on a Balance board |
Who may qualify
- Ages
- 50 to 80 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
- impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.)
Key exclusion criteria (3 listed)
- current acute exacerbation of COPD
- carbon dioxide pressure of more than 45 mmHg at rest
- any contraindication for vibration Training (e.g. acute deep vein thrombosis)
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 |
|---|---|---|
| Balance Training on a vibration platformn=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz. | Other | Whole Body Vibration training |
| Conventional Balance trainingn=24 patients with COPD, Exercises will be performed on a Balance pad | Other | Conventional Balance training |
Primary outcome
Change in Balance Performance during semi Tandem stance
Time frame: measurement on Day 1 and 21
patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force.
11 secondary outcomes
Change in muscle power during counter movement jump
Time frame: measurement on Day 1 and 21
Change in performance of the 5-Repetition-Raise-Test
Time frame: measurement on Day 1 and 21
Change in performance of the 1-Minute-Chair-Rise-Test
Time frame: measurement on Day 1 and 21
Change in Peak muscle strength of the knee Extension muscles
Time frame: measurement on Day 1 and 21
Change in Peak muscle strength of the knee Flexion muscles
Time frame: measurement on Day 1 and 21
Change in 6-minute Walk Distance
Time frame: measurement on Day 1 and 21
Change in 4m Gait Speed Test
Time frame: measurement on Day 1 and 21
Change in step symmetry during 20m walking
Time frame: measurement on Day 1 and 21
Change in Hospital anxiety and Depression scale
Time frame: measurement on Day 1 and 21
Change in balance performance during Romberg stance
Time frame: measurement on Day 1 and 21
Change in Balance Performance during 1-leg stance
Time frame: measurement on Day 1 and 21
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 Dec 2019.
- Derived from this study: PubMed 33947416Gloeckl R, Schneeberger T, Leitl D, Reinold T, Nell C, Jarosch I, Kenn K, Koczulla AR. Whole-body vibration training versus conventional balance training in patients with severe COPD-a randomized, controlled trial. Respir Res. 2021 May 4;22(1):138. doi: 10.1186/s12931-021-01688-x.
- 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.
Klaus Kenn, MD principal investigator
Schoen Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training on a vibration platform and Conventional Balance 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 2 inclusion and 3 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 Dec 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?
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?
Change in Balance Performance during semi Tandem stance (time frame: measurement on Day 1 and 21). 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 NCT03157986, 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 24 Dec 2019.