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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02050945

Collaborator

Copenhagen University Hospital, Hvidovre (Other)

Enrollment

Locations

Arms

13.9

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COPD Exercise Resistance Training	Behavioral: Resistance training Behavioral: Endurance training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Skeletal muscle function [At baseline and after 8 weeks of traning]
Muscle biopsy

Secondary Outcome Measures

Flow mediated dilation [Change from baseline at 8 weeks]
Endothelium function
Body composition [Change from baseline at 8 weeks]
DEXA scan
6 min walking test [Change from baseline at 8 weeks]
Health Related Quality of Life - COPD assessment test (CAT) [Change from baseline at 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Physical Activity Resarch	Copenhagen	Capital Region	Denmark	2100
2	Centre of Physical Activity Research	Copenhagen	Capital Region	Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark
Copenhagen University Hospital, Hvidovre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Rasmussen Rinnov, Administrator, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT02050945

Other Study ID Numbers:

H-2-2013-150

First Posted:

Jan 31, 2014

Last Update Posted:

Apr 21, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 21, 2015