search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
whole body vibration
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease (COPD), Muscle strenght, Aged

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de PernambucoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WVB Training

Arm Description

Outcomes

Primary Outcome Measures

Walked distance in 6MWT
Change from baseline in distance walked test 6-minute walk test at 3 months.

Secondary Outcome Measures

Respiratory muscle strength
Increase in respiratory muscle strength.

Full Information

First Posted
June 18, 2012
Last Updated
December 1, 2014
Sponsor
Universidade Federal de Pernambuco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT01649310
Brief Title
Whole Body Vibration in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effects of Whole Body Vibration Training in Chronic Obstructive Pulmonary Disease (COPD) Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic obstructive pulmonary disease (COPD), Muscle strenght, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WVB Training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
whole body vibration
Other Intervention Name(s)
Equipment: Power Plate my3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walked distance in 6MWT
Description
Change from baseline in distance walked test 6-minute walk test at 3 months.
Time Frame
Increase in distance walked at baseline and 3 months
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Increase in respiratory muscle strength.
Time Frame
Change from baseline in respiratory muscle strength at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Marinho Patricia Marinho, PhD
Phone
55 81 21268496
Email
patmarinho@yahoo.com.br
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.740-560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia EM Marinho, PhD
Phone
8191069204
Email
patmarinho@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Patricia EM Marinho, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22104540
Citation
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.
Results Reference
background
PubMed Identifier
23692550
Citation
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.
Results Reference
background
PubMed Identifier
25624756
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs