The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease

April 19, 2015 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark

The purpose of the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of life, 6 min walking distance, flow mediated dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will test the hypothesis that:

Resistance training is superior to endurance training in patients with COPD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Centre of Physical Activity Resarch
      • Copenhagen, Capital Region, Denmark, 2100
        • Centre of Physical Activity Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • FEV1/FVC fixed ratio <0.70, FEV1: <60% of predicted and MRC > or equal to 3
  • Arterial oxygen saturation at rest> 90%, BMI >18, LVEF> 45.
  • Age: 40 - 80 years

The medical treatment will be continued unchanged during the study and additional prednisolone and /or antibiotic treatment will be prescribed in case of acute exacerbation.

Exclusion Criteria:

  • Unstable ischemic heart disease, severe heart valve failure, pulmonary emboli, severe heart failure, severe infections, musculoskeletal disorders, malignant disease, contraindicated medicine as MAO inhibitors and anticoagulants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with COPD
Patients with COPD are to be trained 3 times a week for 8 weeks
Behavioral: Resistance training
Other Names:
  • Strength training, skeletal muscle, exercise, muscle training
Active Comparator: Control patients with COPD
Control patients with COPD are to be trained 3 times a week for 8 weeks
Behavioral: Endurance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle function
Time Frame: At baseline and after 8 weeks of traning
Muscle biopsy
At baseline and after 8 weeks of traning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow mediated dilation
Time Frame: Change from baseline at 8 weeks
Endothelium function
Change from baseline at 8 weeks
Body composition
Time Frame: Change from baseline at 8 weeks
DEXA scan
Change from baseline at 8 weeks
6 min walking test
Time Frame: Change from baseline at 8 weeks
Change from baseline at 8 weeks
Health Related Quality of Life - COPD assessment test (CAT)
Time Frame: Change from baseline at 8 weeks
Change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Copenhagen University Hospital, Hvidovre

Investigators

  • Study Chair: Stefan Mortensen, DMSc, Centre of Inflammation and Metabolism, University of Copenhagen, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 19, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2013-150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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