NCT01380639

Brief Summary

The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 28, 2013

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 1, 2011

Results QC Date

September 27, 2013

Last Update Submit

April 10, 2019

Conditions

Keywords

COPD III/IV6-Minutes-Walking-DistanceVibration trainingGalileoPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 6-Minute-Walking-Distance

    Change in 6-minute-walking-distance from baseline to day 19

    day 1, day 19

Secondary Outcomes (6)

  • Body Composition

    day 1 and 19

  • Isometric Maximum Handgrip Force

    day 1, day 19

  • BODE-Score

    day 1, day 19

  • Lung Function

    day 1

  • Arterial Blood Gas

    day 1

  • +1 more secondary outcomes

Study Arms (2)

Rehabilitation with vibration training

EXPERIMENTAL
Other: whole body vibration training

Rehabilitation without vibration training

NO INTERVENTION

Interventions

performing squats for 3x3 minutes while using vibration platform three times a week

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)

Schön Klinikum Berchtesgadener Land

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

Results Point of Contact

Title
Dr. Klaus Kenn
Organization
Schön Klinik Berchtesgadener Land

Publication Agreements

PI is Sponsor Employee
Yes

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

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 30, 2019

Results First Posted

November 28, 2013

Record last verified: 2019-04

Locations