NCT01380652

Brief Summary

The aim of this study is to investigate the change of physical activity in COPD-patients performing a whole body vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a standard rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

April 1, 2011

Last Update Submit

March 5, 2015

Conditions

Keywords

COPD III/IVActivity MonitoringSenseWearVibration trainingGalileoPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Activity

    change in activity from baseline to day 17

    day 2 and 17

Secondary Outcomes (3)

  • Diffusion Capacity

    day 1

  • BODE-Score

    day 1 and 19

  • lung function

    day 1

Study Arms (2)

rehabilitation with vibration training

EXPERIMENTAL
Procedure: whole body vibration training

rehabilitation without vibration training

NO INTERVENTION

Interventions

pulmonary rehabilitation with strength and endurance training and additionally vibration training

Also known as: whole body vibration, Galileo
rehabilitation with vibration training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic obstructive pulmonary disease III/IV

You may not qualify if:

  • Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
  • Severe disease other than COPD, that could influence the results of the study
  • Abuse of alcohol or drugs
  • Simultaneously participation in another study
  • Tachypnea (\>30/min)
  • Severe exacerbation during rehabilitation
  • Cardiac insufficiency (NYHA IV)
  • Myocardial infarction during the last 6 weeks
  • Mental-health problem
  • Pregnancy
  • Known HIV-infection
  • Slipped disk
  • Acute discopathy
  • Acute thrombosis
  • Implants in trained regions of the body (lower extremities)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 1, 2011

First Posted

June 27, 2011

Study Start

September 1, 2010

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations