- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649310
Whole Body Vibration in Chronic Obstructive Pulmonary Disease (COPD) Patients
Effects of Whole Body Vibration Training in Chronic Obstructive Pulmonary Disease (COPD) Patients: a Randomized Controlled Trial
The whole body vibration offers better treatment adherence among the elderly, minimizing effort and additional stress to the cardiovascular system and skeletal muscles compared to conventional exercise programs.
Hypothesis: Patients with COPD undergoing a training program on the whole body vibration show better performance in the 6MWT and improvement in muscle strength.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the elderly and in COPD patients weight loss includes sarcopenia, resulting from aging itself or due to disuse or disease states associated with and represents the reduction in muscle mass, leading to decreased strength and endurance, with repercussions on the functional abilities of the same. It reduces the power and muscle strength with aging which represent decreasing to carry out daily physical tasks.
In COPD, exacerbations worsen the loss of muscle mass, affecting the respiratory and peripheral muscles, exercise capacity and survival rates, and in the case of severe malnutrition in advanced cases of the disease, the implications of this state are disability which occur between 10-15% in those with mild obstruction and 25% in moderate to severe obstructive and are associated with worse prognosis.
The whole body vibration could be an efficient combination of training methods for elderly patients and is based on the generation of sinusoidal vibrations offered by a platform, which stimulates the muscle spindles resulting in activation of neurons α engines and develop muscle contractions, presenting itself as an alternative to conventional treatment for muscular endurance as well as improving physical fitness
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Marinho Patricia Marinho, PhD
- Phone Number: 55 81 21268496
- Email: patmarinho@yahoo.com.br
Study Locations
-
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Pernambuco
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Recife, Pernambuco, Brazil, 50.740-560
- Recruiting
- Universidade Federal de Pernambuco
-
Contact:
- Patricia EM Marinho, PhD
- Phone Number: 8191069204
- Email: patmarinho@yahoo.com.br
-
Principal Investigator:
- Patricia EM Marinho, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smoking history, occupational or environmental exposure to pollutants and / or cough, hypersecretion or dyspnea,
- FEV1 <80% predicted and postbronchodilator FEV1/FVC <70% to confirm the diagnosis of airway obstruction air not fully reversible bronchodilator therapy,
- Have the ability to perform the walk test, 6 minutes, absence of comorbidities that preclude the achievement of effort (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnea)
- Preserved cognitive functioning,
- Clinically stable during the study period
Exclusion Criteria:
- Have cognitive impairment, hearing or visual compromise the response to the questionnaires used in this study
- Make modifications to the appliance neuro-musculo-skeletal system that prevents the completion of the 6MWT
- Be participating in physical activity programs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WVB Training
|
Exercises on the platform will be made in semi-squat position, static.
In the first month training will be held for 10 minutes for the exercises on the platform, 30 seconds of vibration of low intensity, interspersed with rest 60 seconds while standing beside the platform.
In the second month training will be held for 15 minutes, lasting 60 seconds of vibration and 30 seconds of rest in standing beside the platform.
For the first two weeks training will have low intensity and the last two weeks training will have higher vibration.
In the third month, training will be held for 20 minutes, 60 seconds of vibration and 30 seconds of rest while standing beside the platform.
The intensity of the vibration will be high.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walked distance in 6MWT
Time Frame: Increase in distance walked at baseline and 3 months
|
Change from baseline in distance walked test 6-minute walk test at 3 months.
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Increase in distance walked at baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: Change from baseline in respiratory muscle strength at 3 months
|
Increase in respiratory muscle strength.
|
Change from baseline in respiratory muscle strength at 3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Gloeckl R, Heinzelmann I, Baeuerle S, Damm E, Schwedhelm AL, Diril M, Buhrow D, Jerrentrup A, Kenn K. Effects of whole body vibration in patients with chronic obstructive pulmonary disease--a randomized controlled trial. Respir Med. 2012 Jan;106(1):75-83. doi: 10.1016/j.rmed.2011.10.021. Epub 2011 Nov 21.
- Pleguezuelos E, Perez ME, Guirao L, Samitier B, Costea M, Ortega P, Gonzalez MV, Del Carmen VA, Ovejero L, Moreno E, Miravitlles M. Effects of whole body vibration training in patients with severe chronic obstructive pulmonary disease. Respirology. 2013 Aug;18(6):1028-34. doi: 10.1111/resp.12122.
- Braz Junior DS, Dornelas de Andrade A, Teixeira AS, Cavalcanti CA, Morais AB, Marinho PE. Whole-body vibration improves functional capacity and quality of life in patients with severe chronic obstructive pulmonary disease (COPD): a pilot study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 12;10:125-32. doi: 10.2147/COPD.S73751. eCollection 2015.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Patricia
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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