NCT01649310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

June 18, 2012

Last Update Submit

December 1, 2014

Conditions

Keywords

Chronic obstructive pulmonary disease (COPD)Muscle strenghtAged

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Respiratory muscle strength

    Change from baseline in respiratory muscle strength at 3 months

Study Arms (1)

WVB Training

EXPERIMENTAL
Other: whole body vibration

Interventions

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.

Also known as: Equipment: Power Plate my3
WVB Training

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50.740-560, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22104540BACKGROUND
  • 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.

    PMID: 23692550BACKGROUND
  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Marinho Patricia Marinho, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2012

First Posted

July 25, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations