Pulmonary Disease, Chronic ObstructiveNCT03735615
Sprint Interval Training in Patients With Chronic Obstructive Lung Disease
A study testing sprint interval training in people with Pulmonary Disease, Chronic Obstructive, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- sprint interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2018to 10 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
- post bronchodilator FEV < 50%
Who cannot join
- having participated in a pulmonary rehabilitation program during the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- sprint interval training
- Keywords
- Exercise therapy, High-Intensity Interval Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sprint interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic obstructive lung disease | Experimental | Not described Receives: Behavioral: sprint interval training |
| healthy control | Experimental | Not described Receives: Behavioral: sprint interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise cycle time to exhaustion
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Nov 2018
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 patients with stable chronic obstructive lung disease (COPD) stage 3 and 4 according to GOLD guidelines (www.goldcopd.org), recruited from outpatient ward of the Lung Department at St Olav University Hospital. Control group of 10 age-matched but otherwise healthy subjects
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735615
- Sponsor's protocol ID
- 2018/723
- Status last verified
- Jan 2020
- First submitted
- 7 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sprint Interval Training in Patients With Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT03735615
- Acronym / sponsor ID
- 2018/723
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Exercise therapy, High-Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 patients with stable chronic obstructive lung disease (COPD) stage 3 and 4 according to GOLD guidelines (www.goldcopd.org), recruited from outpatient ward of the Lung Department at St Olav University Hospital. Control group of 10 age-matched but otherwise healthy subjects
| Arm | Type | Receives |
|---|---|---|
| chronic obstructive lung disease | Experimental | Behavioral: sprint interval training |
| healthy control | Experimental | Behavioral: sprint interval training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
- post bronchodilator FEV < 50%
Key exclusion criteria (1 listed)
- having participated in a pulmonary rehabilitation program during the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sprint interval trainingEach 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. | Behavioural | chronic obstructive lung disease, healthy control |
Primary outcome
exercise cycle time to exhaustion
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, phd study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sprint interval training in people with Pulmonary Disease, Chronic Obstructive, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise cycle time to exhaustion (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.