NCT01715337

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2010

Longer than P75 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

February 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

October 24, 2012

Last Update Submit

April 14, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

muscle fibrecapillaryrehabilitationexercise training

Outcome Measures

Primary Outcomes (1)

  • Change in the amount of capillaries in muscle fibre type I

    change from pre (day 1) to post rehabilitation (day 21)

Secondary Outcomes (3)

  • 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)

  • Change in the cross-sectional area of muscle fibre type IIa

    Change from pre (day 1) to post rehabilitation (day 21)

Study Arms (1)

pulmonary rehabilitation

OTHER
Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitationOTHER

3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.

pulmonary rehabilitation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive pulmonary disease
  • FEV1%pred. \< 50%

You may not qualify if:

  • acute exacerbation
  • exacerbation in the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik 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

Study Officials

  • Klaus Kenn, Dr. med.

    Klinikum Berchtesgadener Land

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician (department of pneumology)

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 26, 2012

Study Start

February 1, 2010

Primary Completion

March 1, 2013

Study Completion

April 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

DE(1)