Effects of Exercise Training in Chronic Obstructive Pulmo... | NCT01380626

Studies
Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

NCT01380626

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Dec 17, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Alpha-1-antitrypsin-deficiency

Interventions

exercise 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

Dec 2013

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 2013Actual

First Submitted Date

Jun 22, 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

Dec 16, 2013

Last Update Posted Date

Dec 17, 2013Estimated

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
Grifols Therapeutics LLC	INDUSTRY
Alpha-1 Foundation	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

Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise training	Experimental		Procedure: exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise training	Procedure	strength and endurance training, 5 time per week.	exercise training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
aerobic and anaerobic enzymes	changes in quantity of enzymes from baseline to day 23	day 2 and 23

Secondary Outcomes

Measure	Description	Time Frame
maximal exercise capacity in incremental cycling test	Change in max. exercise capacity from baseline to day 23	day 2 and 23
6-minute-walking distance	change in 6-minute-walking distance from baseline to day 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD
Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
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, Schön Klinik	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Berchtesgadener Land		Berchtesgaden		83471	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D019896	alpha 1-Antitrypsin Deficiency

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

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D000076663	Endurance Training
D055070	Resistance Training

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided