- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735615
Sprint Interval Training in Patients With Chronic Obstructive Lung Disease
Exercise therapy is a cornerstone in the management of patients with Chronic Obstructive Pulmonary disease (COPD), and supervised walking exercise three times a week over 12 weeks improves walking ability and quality of life. Despite this, very few patients exercise on a regular basis. The underuse of exercise in COPD patients can partly be explained by discomfort during exercise because it evokes dyspnea, and thereby explain lack of participation in exercise. If the goal is to offer the best medical therapy to these patients, new and effective exercise training methods must be explored and defined since exercise training is an important part of pulmonary rehabilitation.
Intention is to study a new training method called sprint interval training (SIT), which consists of high intensity bouts with very short duration. The idea behind SIT is to avoid the dyspnea associated with traditional endurance training, thus maximizing exercise power without excessive discomfort. The investigators will study training adaptations in patients with COPD and compare the results with age-matched controls.
It is expected that both COPD-patients and healthy elderly will improve exercise cycle time until exhaustion after SIT training, and also that the improvement will be larger in the healthy group due to higher absolute training intensity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- St Olavs University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (patients):
- stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
- post bronchodilator FEV < 50%
Exclusion Criteria:
- having participated in a pulmonary rehabilitation program during the last 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: chronic obstructive lung disease
|
Each training session will be performed 3 times per week for 3 weeks.
Each session consists of 3-5x20 sec all-out cycling efforts against a load corresponding to 0.05-0.07
kg/kg body mass, separated by 3-5 min of low intensity cycling (20-50 W), on a lode bicycle ergometer (Excalibur Sport V2.0, Groningen, the Netherlands).
All training sessions includes a 5 min warm-up and 3 min cool-down.
|
EXPERIMENTAL: healthy control
|
Each training session will be performed 3 times per week for 3 weeks.
Each session consists of 3-5x20 sec all-out cycling efforts against a load corresponding to 0.05-0.07
kg/kg body mass, separated by 3-5 min of low intensity cycling (20-50 W), on a lode bicycle ergometer (Excalibur Sport V2.0, Groningen, the Netherlands).
All training sessions includes a 5 min warm-up and 3 min cool-down.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
exercise cycle time to exhaustion
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/723
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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