Back to resultsWhole Body Vibration in Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A vertical vibration platform Fitybe
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
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.
Sites / Locations
- Eulogio Pleguezuelos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
static work with a vertical vibration platform
Control group
Arm Description
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.
general recommendations about physical activity and lifestyle
Outcomes
Primary Outcome Measures
isokinetic knee flexor and extensor testing muscular force
the change between basal - and 3 months follow up.
distance performed in the six minutes walking test (6MWT)
the change between basal - and 3 months follow up.
Secondary Outcome Measures
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
the change between basal - and 3 months follow up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01850173
Brief Title
Whole Body Vibration in Chronic Obstructive Pulmonary Disease
Official Title
Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
static work with a vertical vibration platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
general recommendations about physical activity and lifestyle
Intervention Type
Device
Intervention Name(s)
A vertical vibration platform Fitybe
Intervention Description
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.
Primary Outcome Measure Information:
Title
isokinetic knee flexor and extensor testing muscular force
Description
the change between basal - and 3 months follow up.
Time Frame
basal, 3 months follow up
Title
distance performed in the six minutes walking test (6MWT)
Description
the change between basal - and 3 months follow up.
Time Frame
Basal, 3 months follow up
Secondary Outcome Measure Information:
Title
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Description
the change between basal - and 3 months follow up.
Time Frame
Basal, 3 month follow up
Other Pre-specified Outcome Measures:
Title
Complications
Description
cardiac events, increase in respiratory symptoms, knee pain during whole body vibration training.
Time Frame
3 months follow up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eulogio Pleguezuelos, PhD
Organizational Affiliation
Hospital de Mataró
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eulogio Pleguezuelos
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.csdm.cat
Description
Hospital de Mataró. Consorci Sanitari del Maresme
Learn more about this trial
Whole Body Vibration in Chronic Obstructive Pulmonary Disease
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