Back to resultsThe Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD, Exercise, Resistance Training
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Endurance training
Sponsored by
About this trial
This is an interventional basic science trial for COPD
Eligibility Criteria
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.
Sites / Locations
- Centre of Physical Activity Resarch
- Centre of Physical Activity Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with COPD
Control patients with COPD
Arm Description
Patients with COPD are to be trained 3 times a week for 8 weeks
Control patients with COPD are to be trained 3 times a week for 8 weeks
Outcomes
Primary Outcome Measures
Skeletal muscle function
Muscle biopsy
Secondary Outcome Measures
Flow mediated dilation
Endothelium function
Body composition
DEXA scan
6 min walking test
Health Related Quality of Life - COPD assessment test (CAT)
Full Information
NCT ID
NCT02050945
First Posted
January 27, 2014
Last Updated
April 19, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre
1. Study Identification
Unique Protocol Identification Number
NCT02050945
Brief Title
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
Official Title
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Exercise, Resistance Training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with COPD
Arm Type
Experimental
Arm Description
Patients with COPD are to be trained 3 times a week for 8 weeks
Arm Title
Control patients with COPD
Arm Type
Active Comparator
Arm Description
Control patients with COPD are to be trained 3 times a week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Other Intervention Name(s)
Strength training, skeletal muscle, exercise, muscle training
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Primary Outcome Measure Information:
Title
Skeletal muscle function
Description
Muscle biopsy
Time Frame
At baseline and after 8 weeks of traning
Secondary Outcome Measure Information:
Title
Flow mediated dilation
Description
Endothelium function
Time Frame
Change from baseline at 8 weeks
Title
Body composition
Description
DEXA scan
Time Frame
Change from baseline at 8 weeks
Title
6 min walking test
Time Frame
Change from baseline at 8 weeks
Title
Health Related Quality of Life - COPD assessment test (CAT)
Time Frame
Change from baseline at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Mortensen, DMSc
Organizational Affiliation
Centre of Inflammation and Metabolism, University of Copenhagen, Rigshospitalet
Official's Role
Study Chair
Facility Information:
Facility Name
Centre of Physical Activity Resarch
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Centre of Physical Activity Research
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
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