COPDNCT01850173
Whole Body Vibration in Chronic Obstructive Pulmonary Disease
A study testing A vertical vibration platform Fitybe in people with COPD, run by Hospital de Mataró at 1 site in Spain.
Trial summary
The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme. Read more about this study
- Who is it for?
- Ages 55 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- A vertical vibration platform Fitybe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Dec 2011
- 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 55 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 0.7 and FEV1 < 50% predicted,
- stable disease defined as no exacerbation,
- hospital admission or change in treatment in the previous 3 months.
Who cannot join
- other significant respiratory disease (bronchiectasis,
- lung fibrosis, asthma, etc),
- active smoking,
- severe cardiovascular,
- neurological, and/or metabolic pathology that could interfere with the results,
- total hip, knee or ankle arthroplasty,
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- previous vitreous haemorrhage,
- severe alcoholism (> 80 g/day) and
- severe malnutrition (BMI < 19 Kg/m2) to reduce the risk of falling and dropouts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.
- Conditions
- COPD
- Being tested
- A vertical vibration platform Fitybe
- 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.
A vertical vibration platform FitybeDevice
They performed 6 series, and each series consisted of four 30-second repetitions with a frequency of 35 Hz and 2 millimeters of amplitude, with 60 seconds of rest between each series.
| Study group | Role | What they receive |
|---|---|---|
| static work with a vertical vibration platform | Experimental | The training was designed to perform static work of the lower limbs. Patients worked in a squatting position, with 30º of hip flexion and 55º of knee flexion, holding onto the bars of the WBV platform. Receives: Device: A vertical vibration platform Fitybe |
| Control group | No intervention | general recommendations about physical activity and lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
isokinetic knee flexor and extensor testing muscular force
the change between basal - and 3 months follow up.
Measured: basal, 3 months follow up
distance performed in the six minutes walking test (6MWT)
the change between basal - and 3 months follow up.
Measured: Basal, 3 months follow up
Secondary outcomes (1)
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
the change between basal - and 3 months follow up.
Measured: Basal, 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eulogio Pleguezuelos, Hospital de Mataró
- Investigators
- Eulogio Pleguezuelos, PhD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850173
- Sponsor's protocol ID
- MAT-VIB01
- Status last verified
- May 2013
- First submitted
- 2 May 2013
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT01850173
- Acronym / sponsor ID
- MAT-VIB01
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 May 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.
The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| static work with a vertical vibration platform | Experimental | Device: A vertical vibration platform FitybeThe training was designed to perform static work of the lower limbs. Patients worked in a squatting position, with 30º of hip flexion and 55º of knee flexion, holding onto the bars of the WBV platform. |
| Control group | No intervention | –general recommendations about physical activity and lifestyle |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 0.7 and FEV1 < 50% predicted,
- stable disease defined as no exacerbation,
- hospital admission or change in treatment in the previous 3 months.
Key exclusion criteria (9 listed)
- other significant respiratory disease (bronchiectasis,
- lung fibrosis, asthma, etc),
- active smoking,
- severe cardiovascular,
- neurological, and/or metabolic pathology that could interfere with the results,
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 |
|---|---|---|
| A vertical vibration platform FitybeThey performed 6 series, and each series consisted of four 30-second repetitions with a frequency of 35 Hz and 2 millimeters of amplitude, with 60 seconds of rest between each series. | Device | static work with a vertical vibration platform |
Primary outcome
isokinetic knee flexor and extensor testing muscular force
Time frame: basal, 3 months follow up
the change between basal - and 3 months follow up.
distance performed in the six minutes walking test (6MWT)
Time frame: Basal, 3 months follow up
the change between basal - and 3 months follow up.
1 secondary outcome
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Time frame: Basal, 3 month follow up
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 9 May 2013.
- Hospital de Mataró. Consorci Sanitari del MaresmeLink 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.
Eulogio Pleguezuelos, PhD principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A vertical vibration platform Fitybe in people with COPD, run by Hospital de Mataró at 1 site in Spain.
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 9 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 9 May 2013. 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 Spain. 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?
isokinetic knee flexor and extensor testing muscular force (time frame: basal, 3 months follow up). The study lists 2 primary outcomes in all. 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 9 May 2013.