Whole Body Vibration in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850173
• Other study ID #: MAT-VIB01
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: May 6, 2013
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Spain	Eulogio Pleguezuelos	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	cardiac events, increase in respiratory symptoms, knee pain during whole body vibration training.	3 months follow up	Yes
Primary	isokinetic knee flexor and extensor testing muscular force	the change between basal - and 3 months follow up.	basal, 3 months follow up	Yes
Primary	distance performed in the six minutes walking test (6MWT)	the change between basal - and 3 months follow up.	Basal, 3 months follow up	No
Secondary	respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)	the change between basal - and 3 months follow up.	Basal, 3 month follow up	Yes

External Links

•   Hospital de Mataró. Consorci Sanitari del Maresme