Whole Body Vibration in Chronic Obstructive Pulmonary Disease
Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedMay 9, 2013
May 1, 2013
1.8 years
May 2, 2013
May 6, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
isokinetic knee flexor and extensor testing muscular force
the change between basal - and 3 months follow up.
basal, 3 months follow up
distance performed in the six minutes walking test (6MWT)
the change between basal - and 3 months follow up.
Basal, 3 months follow up
Secondary Outcomes (1)
respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Basal, 3 month follow up
Other Outcomes (1)
Complications
3 months follow up
Study Arms (2)
static work with a vertical vibration platform
EXPERIMENTALThe 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 INTERVENTIONgeneral recommendations about physical activity and lifestyle
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eulogio Pleguezuelos
Mataró, Barcelona, 08304, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eulogio Pleguezuelos, PhD
Hospital de Mataró
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 9, 2013
Study Start
February 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 9, 2013
Record last verified: 2013-05