- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00908765
Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients
Effects of Aerobe Interval Training and Moderate Continuous Training in COPD Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trondheim, Norway, 7089
- Department of circulation and medical imaging , NTNU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobe Interval Training
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.
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Other Names:
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Active Comparator: Moderate Continous Training
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
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VO2-peak
Time Frame: At inclusion and after 12 weeks of exercise training
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At inclusion and after 12 weeks of exercise training
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac function
Time Frame: At inclusion and after 12 weeks of exercise training
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At inclusion and after 12 weeks of exercise training
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Skeletal muscle function
Time Frame: At inclusion and after 12 weeks of exercise training
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At inclusion and after 12 weeks of exercise training
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Collaborators and Investigators
Investigators
- Principal Investigator: Sigurd Steinshamn, MD PhD, NTNU , Trondheim
- Principal Investigator: Eivind Brønstad, MD, NTNU, Trondheim
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 42008754
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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