Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
COPD, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for COPD focused on measuring Exercise Training COPD
Eligibility Criteria
Inclusion Criteria:
- COPD with FEV1 25-60 % of exp , FEV1%FVC<70 %. Age 45-80 years
Exclusion Criteria:
- Heart failure
- symptomatic coronary artery disease
- cancer
- alcohol and drug abuse
- severe mental illness
- Lower respiratory infection last 4 weeks
- participation in exercise- or lung rehabilitation program last 3 months.
- oral steroid use
Sites / Locations
- Department of Circulation and Medical Imaging , NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aerobe Interval Training
Moderate Continous Training
Arm Description
High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.
Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks
Outcomes
Primary Outcome Measures
VO2-peak
Secondary Outcome Measures
Cardiac function
Skeletal muscle function
Full Information
NCT ID
NCT00908765
First Posted
April 20, 2009
Last Updated
January 2, 2013
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00908765
Brief Title
Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients
Official Title
Effects of Aerobe Interval Training and Moderate Continuous Training in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. The investigators want to study the physiological response to two different training programs (High intensity aerobe interval training and moderate continuous aerobe training)with special focus on cardiac and skeletal muscle adaptions
Detailed Description
Reduced exercise tolerance is one of the hallmarks of COPD and The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contributes to this impairment . Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction
Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation. It is still uncertain what type of endurance training that is most favourable for COPD patients.
In patients with heart failure and metabolic syndrome aerobe interval exercise have be shown to be superior in improving aerobic capacity and cardiac function
We therefore want conduct a study comparing training effects in patients with moderate to severe COPD, that participated in an identical training program that in HF and metabolic syndrome patients gave significant improvement in aerobic capacity, cardiac function and skeletal muscle function.
Patients will therefore be assigned to either 4x4 minutes high intensity interval treadmill exercise or continuous moderate intensity treadmill exercise 3 times pr week for 12 weeks. Aerobic capacity and work economy, pulmonary,cardiac and skeletal muscle function before and after the exercise training will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease
Keywords
Exercise Training COPD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobe Interval Training
Arm Type
Active Comparator
Arm Description
High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.
Arm Title
Moderate Continous Training
Arm Type
Active Comparator
Arm Description
Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
non
Intervention Description
High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.
Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks
Primary Outcome Measure Information:
Title
VO2-peak
Time Frame
At inclusion and after 12 weeks of exercise training
Secondary Outcome Measure Information:
Title
Cardiac function
Time Frame
At inclusion and after 12 weeks of exercise training
Title
Skeletal muscle function
Time Frame
At inclusion and after 12 weeks of exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD with FEV1 25-60 % of exp , FEV1%FVC<70 %. Age 45-80 years
Exclusion Criteria:
Heart failure
symptomatic coronary artery disease
cancer
alcohol and drug abuse
severe mental illness
Lower respiratory infection last 4 weeks
participation in exercise- or lung rehabilitation program last 3 months.
oral steroid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigurd Steinshamn, MD PhD
Organizational Affiliation
NTNU , Trondheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eivind Brønstad, MD
Organizational Affiliation
NTNU, Trondheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Circulation and Medical Imaging , NTNU
City
Trondheim
ZIP/Postal Code
7089
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23272664
Citation
Bronstad E, Tjonna AE, Rognmo O, Dalen H, Heggli AM, Wisloff U, Ingul CB, Steinshamn S. Aerobic exercise training improves right- and left ventricular systolic function in patients with COPD. COPD. 2013 Jun;10(3):300-6. doi: 10.3109/15412555.2012.745843. Epub 2012 Dec 28.
Results Reference
result
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Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients
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