Whole Body Vibration in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Effects of Whole Body Vibration Training in Chronic Obstructive Pulmonary Disease (COPD) Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01649310
• Other study ID #: Patricia
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2012
• Last updated: December 1, 2014
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Universidade Federal de Pernambuco
• Contact: Patricia Marinho Patricia Marinho, PhD
• Phone: 55 81 21268496
• Email: patmarinho[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• whole body vibration
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

Pleguezuelos E, Pérez ME, Guirao L, Samitier B, Costea M, Ortega P, González 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walked distance in 6MWT	Change from baseline in distance walked test 6-minute walk test at 3 months.	Increase in distance walked at baseline and 3 months	Yes
Secondary	Respiratory muscle strength	Increase in respiratory muscle strength.	Change from baseline in respiratory muscle strength at 3 months	Yes

External Links

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