Vibration Training in Chronic Obstructive Pulmonary Disea... | NCT01380652

Studies
Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation

NCT01380652

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

whole body vibration training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rehabilitation with vibration training	Experimental		Procedure: whole body vibration training
rehabilitation without vibration training	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whole body vibration training	Procedure	pulmonary rehabilitation with strength and endurance training and additionally vibration training	rehabilitation with vibration training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Activity	change in activity from baseline to day 17	day 2 and 17

Secondary Outcomes

Measure	Description	Time Frame
Diffusion Capacity		day 1
BODE-Score	Changes in Bode-Score from baseline to day 19	day 1 and 19

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

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)
Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
Acute tendinopathy in trained regions of the body
Acute hernia
Fresh fractures, wounds or scars in trained regions of the body
Gallstones or stones in the urinary tract collection system

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Berchtesgadener Land, Schön Kliniken		Schönau am Königssee		83471	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided