NCT01135966

Brief Summary

Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with chronic lung disease based on a growing body of scientific evidence. A set of evidence-based guidelines were published in American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the published literature in pulmonary rehabilitation has increased substantially, and other societies have published important statements about pulmonary rehabilitation (eg, the American Thoracic Society and the European Respiratory Society). In patients with COPD, there is a strong scientific basis for implementing conventional resistance training (CRT) in addition to endurance training. Endurance training, such as walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance and muscular endurance. However, this type of training may not reverse muscle weakness or atrophy. For that reason, strength training seems to be the optimum training modality to increase muscle mass and strength. Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for resistance training on multigym equipment. In WBV training, the subject stands on a platform that generates vertical sinusoidal vibration, during which static and dynamic exercises can be performed. The present study is conducted to provide an answer on the following question: will a resistance training program, such as the whole body vibration, be even effective than a conventional resistance training program in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

1.2 years

First QC Date

June 2, 2010

Last Update Submit

December 9, 2011

Conditions

Keywords

COPDWhole Body Vibration trainingConventional resistance training

Outcome Measures

Primary Outcomes (1)

  • estimation of the change of 6 MWD before and after 12 weeks resistance training program (CRT versus WBV training)

    estimation of the change of 6 MWD (submaximal walking test)after a 12 week conventional resistance training program or after a 12 week whole body vibration training program

    before and after 12 weeks

Secondary Outcomes (7)

  • changes in muscle strength (quadriceps force)after CRT or after WBV training in patients with COPD

    before and after 12 weeks

  • changes in body composition after CRT or after WBV training in patients with COPD

    before and after 12 weeks

  • changes in maximal exercise capacity after CRT or after WBV training in patients with COPD

    before and after 12 weeks

  • changes in muscle force after CRT or after WBV training in patients with COPD

    before and after 12 weeks

  • changes in Quality of life after CRT or after WBV training in patients with COPD

    beforer and after 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Conventional training

ACTIVE COMPARATOR
Behavioral: Conventional resistance training program

Whole body vibration training

EXPERIMENTAL
Behavioral: Whole body vibration resistance training program

Interventions

Conventional resistance training program is followed.

Conventional training

WBV training on FITVIBE

Whole body vibration training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD candidate for pulmonary rehabilitation
  • Men and female between 40 and 80 years of age
  • Written informed consent to participate

You may not qualify if:

  • Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training.
  • Pacemaker
  • Hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates
  • Uncontrolled diabetes, epilepsy or migraine
  • Osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Publications (1)

  • Salhi B, Malfait TJ, Van Maele G, Joos G, van Meerbeeck JP, Derom E. Effects of Whole Body Vibration in Patients With COPD. COPD. 2015;12(5):525-32. doi: 10.3109/15412555.2015.1008693. Epub 2015 Aug 4.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric Derom, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

November 1, 2011

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations