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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00908765
Other study ID # 42008754
Secondary ID
Status Completed
Phase N/A
First received April 20, 2009
Last updated January 2, 2013
Start date August 2008
Est. completion date September 2009

Study information

Verified date January 2013
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
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

Locations

Country Name City State
Norway Department of Circulation and Medical Imaging , NTNU Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Brønstad E, Tjonna AE, Rognmo Ø, 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VO2-peak At inclusion and after 12 weeks of exercise training No
Secondary Cardiac function At inclusion and after 12 weeks of exercise training No
Secondary Skeletal muscle function At inclusion and after 12 weeks of exercise training No
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