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

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ClinicalTrials.gov Identifier: NCT01649310
Recruitment Status : Unknown
Verified December 2014 by Patrícia Érika de Melo Marinho, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : July 25, 2012
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Patrícia Érika de Melo Marinho, Universidade Federal de Pernambuco

Tracking Information
First Submitted Date  ICMJE June 18, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
Respiratory muscle strength [ Time Frame: Change from baseline in respiratory muscle strength at 3 months ]
Increase in respiratory muscle strength.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Body Vibration in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE Effects of Whole Body Vibration Training in Chronic Obstructive Pulmonary Disease (COPD) Patients: a Randomized Controlled Trial
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE 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.
Other Name: Equipment: Power Plate my3
Study Arms  ICMJE Experimental: WVB Training
Intervention: Other: whole body vibration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 20, 2012)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649310
Other Study ID Numbers  ICMJE Patricia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrícia Érika de Melo Marinho, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Pernambuco
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP