Whole Body Vibration in Chronic Obstructive Pulmonary Disease

May 6, 2013 updated by: Eulogio Pleguezuelos, Hospital de Mataró

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Eulogio Pleguezuelos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • previous vitreous haemorrhage,
  • severe alcoholism (> 80 g/day) and
  • severe malnutrition (BMI < 19 Kg/m2) to reduce the risk of falling and dropouts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: static work with a vertical vibration platform
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.
Device: A vertical vibration platform Fitybe
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.
No Intervention: Control group
general recommendations about physical activity and lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
isokinetic knee flexor and extensor testing muscular force
Time Frame: basal, 3 months follow up
the change between basal - and 3 months follow up.
basal, 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.
Basal, 3 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Time Frame: Basal, 3 month follow up
the change between basal - and 3 months follow up.
Basal, 3 month follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 months follow up
cardiac events, increase in respiratory symptoms, knee pain during whole body vibration training.
3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Mataró

Investigators

  • Principal Investigator: Eulogio Pleguezuelos, PhD, Hospital de Mataró

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAT-VIB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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