Effects of Rehabilitation on Muscle Fibre Composition and... | NCT01715337

Studies
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01715337

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Apr 15, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

pulmonary rehabilitation

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

Apr 2014

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

Feb 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Oct 25, 2012

First Posted Date

Oct 26, 2012Estimated

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

Apr 14, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Kenn, Head physician (department of pneumology), Schön Klinik Berchtesgadener LandPrincipal Investigator

Lead Sponsor

Schön Klinik Berchtesgadener LandOTHER

Collaborators

Name	Class
German Sport University, Cologne	OTHER

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

Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a potential change in muscle fibre composition and in the amount of capillaries in quadriceps muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes standardised exercise training, e.g. cycling and strength training for major muscle groups.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pulmonary rehabilitation	Other		Other: pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulmonary rehabilitation	Other	3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.	pulmonary rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the amount of capillaries in muscle fibre type I		change from pre (day 1) to post rehabilitation (day 21)

Secondary Outcomes

Measure	Description	Time Frame
Change in the amount of capillaries in muscle fibre type IIa		Change from pre (day 1) to post rehabilitation (day 21)
Change in the cross-sectional area of muscle fibre type I		Change from pre (day 1) to post rehabilitation (day 21)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic obstructive pulmonary disease
FEV1%pred. < 50%

Exclusion Criteria:

acute exacerbation
exacerbation in the last 4 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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

Name	Affiliation	Role
Klaus Kenn, Dr. med.	Klinikum Berchtesgadener Land	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schön Klinik Berchtesgadener Land		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