COPDCOPD-HIIT-ACNCT05874999
Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD
A study testing Supramaximal High-Intensity Interval Training at 60% of MPO6, Moderate-Intensity Continuous Training and Supramaximal High-Intensity Interval Training at 80% of MPO6 in people with COPD and Healthy Older Adults, run by Umeå University at 1 site in Sweden.
Trial summary
High-intensity exercise is essential for optimal development of cardiorespiratory fitness and health. This is, however, challenging for most people with chronic obstructive pulmonary disease (COPD) due to ventilatory limitations, leading to exercise at lower intensities accompanied by suboptimal stress on the… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy Older Adults
- What is being tested?
- Supramaximal High-Intensity Interval Training at 60% of MPO6, Moderate-Intensity Continuous Training and Supramaximal High-Intensity Interval Training at 80% of MPO6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 7 Mar 2022to 22 Dec 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD with non-reversible airflow obstruction diagnosis (post-bronchodilator forced expiratory volume during the first second/forced vital capacity (FEV1/FVC) < 0.7)
- Age: > 40 years
- Age: > 40 years
Who cannot join
- Recent exacerbation of COPD (< 6 weeks)
- Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
- Recent lung cancer (< 5 years)
- Unstable cardiac disease and/or cardiac stimulator
- HC
- Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
Show all 10Show fewer
- Any respiratory disease
- Recent lung cancer (< 5 years)
- Unstable cardiac disease and/or cardiac stimulator
- Too low or high physical activity level that prohibits matching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD
High-intensity exercise is essential for optimal development of cardiorespiratory fitness and health. This is, however, challenging for most people with chronic obstructive pulmonary disease (COPD) due to ventilatory limitations, leading to exercise at lower intensities accompanied by suboptimal stress on the cardiovascular and muscular system.
The aims of this cross-over trial is:
- To compare the acute effects of short-duration supramaximal high-intensity interval training (HIIT) vs. traditional moderate-intensity continuous training (MICT) in people with COPD and matched healthy controls (HC).
- To investigate the feasibility of supramaximal HIIT in people with COPD and matched HC.
- To compare the cardiorespiratory demand, exercise intensity and symptoms during a modified Borg Cycle Strength Test (BCST) and a cardiopulmonary exercise test (CPET) in people with COPD and HC.
Read the detailed description
In this study, eligible participants attended the facility four times within 14 days with at least 48 hours of rest between visits.
Exercise tests (visit 1, week 1):
After pulmonary functions tests, a CPET on a stationary bicycle was performed according to international guidelines. After 1.5 hours of recovery, a BCST was performed to assess anaerobic exercise capacity and determine exercise intensities for supramaximal HIIT.
Exercise sessions (visit 2 - week 1; visit 3 - week 2; visit 4 - week 2):
The order of the two first exercise sessions (HIIT at 60% of MPO6 or MICT) on a stationary bicycle were randomized. The exercise session at HIIT at 80% of MPO6 was always the third exercise session.
During all exercise sessions, blood collection was performed at baseline after a 15-minute seated rest. During HIIT, blood was collected immediately after, and 30 minutes after the 10-minute HIIT period. For MICT, blood was collected after 10 minutes (isotime in relation to HIIT), immediately after, and 30 minutes of cycling at 60% MAP.
- Conditions
- COPD, Healthy Older Adults
- Being tested
- Supramaximal High-Intensity Interval Training at 60% of MPO6, Moderate-Intensity Continuous Training, Supramaximal High-Intensity Interval Training at 80% of MPO6
- Keywords
- Acute Exercise, 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.
Supramaximal High-Intensity Interval Training at 60% of MPO6Other
Also called Supramaximal High-Intensity Interval Training at 60% of MPO6 (HIIT60%)
Supramaximal HIIT is performed as 10×6 second intervals against a load of 60% of maximum mean power output for 6 seconds (MPO6) with a 54 second recovery between intervals. The MPO6 was estimated from the BCST.
Duration supramaximal HIIT: 10 minutes
Warm-up and cool-down: 5 minutes at 30% of maximum aerobic power (MAP) obtained during maximal incremental cardiopulmonary exercise test (CPET) on a stationary bicycle.
Moderate-Intensity Continuous TrainingOther
Also called MICT
MICT is performed against a load of 60% of MAP obtained during a maximal incremental CPET on a stationary bicycle.
Duration MICT: 20 minutes
Warm-up and cool-down: 5 minutes at 30% of MAP obtained during maximal incremental CPET on a stationary bicycle.
Supramaximal High-Intensity Interval Training at 80% of MPO6Other
Also called Supramaximal High-Intensity Interval Training at 80% of MPO6 (HIIT80%)
Supramaximal HIIT is performed as 10×6 second intervals against a load of 80% of MPO6 with a 54 second recovery between intervals. The MPO6 was estimated from the BCST.
Duration supramaximal HIIT: 10 minutes
Warm-up and cool-down: 5 minutes at 30% of MAP obtained during maximal incremental CPET on a stationary bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Experimental | People with chronic obstructive pulmonary disease (COPD) (n = 16) Receives: Other: Supramaximal High-Intensity Interval Training at 60% of MPO6; Other: Moderate-Intensity Continuous Training; Other: Supramaximal High-Intensity Interval Training at 80% of MPO6 |
| Healthy Controls (HC) | Active comparator | Healthy controls matched on age, sex and objectively measured physical activity (n = 16) Receives: Other: Supramaximal High-Intensity Interval Training at 60% of MPO6; Other: Moderate-Intensity Continuous Training; Other: Supramaximal High-Intensity Interval Training at 80% of MPO6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise intensity
Produced watt at the set training intensity
Measured: During visit 2 (week 1)
Exercise intensity
Produced watt at the set training intensity
Measured: During visit 3 (week 2)
Exercise intensity
Produced watt at the set training intensity
Measured: During visit 4 (week 2)
Brain-derived neurotrophic factor (BDNF)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
Measured: During visit 2 (week 1)
Brain-derived neurotrophic factor (BDNF)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
Measured: During visit 3 (week 2)
Brain-derived neurotrophic factor (BDNF)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
Measured: During visit 4 (week 2)
Secondary outcomes (14)
Cardiorespiratory demand
Gas exchange parameters (e.g. VO2, VCO2, ventilatory equivalents, RER) and lung volumes (e.g. VE, Vt, breathing frequency) obtained with a metabolic cart (breath by breath methodology) and heart rate (beats per minutes) during exercise during exercise.
Measured: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Venous blood lactate concentration
Measured before, during and after exercise.
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Rating of perceived exertion
Rating of perceived exertion scale (Borg RPE). Minimum value = 6 Maximum value = 20 A higher score means higher exertion.
Measured: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Rating of symptoms
Rating of dyspnea and leg fatigue symptoms via Borg CR (category ratio) 10 during exercise Minimum value = 0 Maximum value = 10 A higher score means higher severity of symptoms
Measured: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Peripheral blood oxygen saturation (SpO2)
SpO2 during exercise
Measured: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Blood pressure
Systolic and diastolic blood pressure during exercise
Measured: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Circulating levels of neurotrophic factors
Plasma or serum concentration (measured as mg/l, ng/l, or pq/l) of irisin, cathepsin B, clusterin, in obtained venous blood samples before, during and after exercise.
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Circulating levels of exerkines
Plasma or serum concentration of interleukin (IL)-1b, IL-4, IL-6, IL-8, IL-10, IL-13, IL-15, IL-17, tumor necrosis factor (TNF)-α, vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), and adiponectin in obtained venous blood samples before, during and after exercise.
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise session completion
Number of uninterrupted exercise sessions
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise preference
Preference for HIIT at 60% of MPO6 or MICT, defined as answer on the following question:
"If the MICT and HIIT would be equally effective in improving your health and physical capacity, which one would you prefer to perform?"
Measured: At the end of visit 3 (week 2)
Session RPE
Rating of session RPE on Borg CR (category ratio) 10 is assessed 30 min after every exercise session Minimum value = 0 Maximum value = 10 A higher score means higher session exertion
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise capacity
Maximal aerobic power (MAP) expressed as produced watt at VO2peak
Measured: During visit 1 (CPET; week 1)
Exercise intensity
Maximum mean power output for 30 seconds (MPO30) in watts
Measured: During visit 1 (BCST; week 1)
Adverse events
Occurence and severity of adverse events. The severity of adverse events will be assessed and rated into four different categories: 1) minor and temporary, 2) serious symptoms (potential risk of severe injury or life threatening, 3) manifest injury or disease and 4) death. An adverse event rate will be calculated for each participant as the total number of sessions during which any adverse events occurred divided by the total number of attended sessions.
Measured: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start7 Mar 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation, Riksförbundet HjärtLung
- Responsible party
- Principal investigator, Andre Nyberg, Umeå University
- Investigators
- Andre Nyberg, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874999
- Sponsor's protocol ID
- COPD-HIIT ACUTE
- Acronym
- COPD-HIIT-AC
- Status last verified
- Jun 2023
- First submitted
- 30 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if individual participant data (IPD) will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD
- ClinicalTrials.gov ID
- NCT05874999
- Acronym / sponsor ID
- COPD-HIIT-AC / COPD-HIIT ACUTE
- Conditions
- COPD, Healthy Older Adults
- Keywords
- Acute Exercise, High-intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation, Riksförbundet HjärtLung
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 25 May 2023 (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.
High-intensity exercise is essential for optimal development of cardiorespiratory fitness and health. This is, however, challenging for most people with chronic obstructive pulmonary disease (COPD) due to ventilatory limitations, leading to exercise at lower intensities accompanied by suboptimal stress on the cardiovascular and muscular system.
The aims of this cross-over trial is:
- To compare the acute effects of short-duration supramaximal high-intensity interval training (HIIT) vs. traditional moderate-intensity continuous training (MICT) in people with COPD and matched healthy controls (HC).
- To investigate the feasibility of supramaximal HIIT in people with COPD and matched HC.
- To compare the cardiorespiratory demand, exercise intensity and symptoms during a modified Borg Cycle Strength Test (BCST) and a cardiopulmonary exercise test (CPET) in people with COPD and HC.
Detailed description
In this study, eligible participants attended the facility four times within 14 days with at least 48 hours of rest between visits.
Exercise tests (visit 1, week 1):
After pulmonary functions tests, a CPET on a stationary bicycle was performed according to international guidelines. After 1.5 hours of recovery, a BCST was performed to assess anaerobic exercise capacity and determine exercise intensities for supramaximal HIIT.
Exercise sessions (visit 2 - week 1; visit 3 - week 2; visit 4 - week 2):
The order of the two first exercise sessions (HIIT at 60% of MPO6 or MICT) on a stationary bicycle were randomized. The exercise session at HIIT at 80% of MPO6 was always the third exercise session.
During all exercise sessions, blood collection was performed at baseline after a 15-minute seated rest. During HIIT, blood was collected immediately after, and 30 minutes after the 10-minute HIIT period. For MICT, blood was collected after 10 minutes (isotime in relation to HIIT), immediately after, and 30 minutes of cycling at 60% MAP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Experimental | Other: Supramaximal High-Intensity Interval Training at 60% of MPO6, Other: Moderate-Intensity Continuous Training, Other: Supramaximal High-Intensity Interval Training at 80% of MPO6People with chronic obstructive pulmonary disease (COPD) (n = 16) |
| Healthy Controls (HC) | Active comparator | Other: Supramaximal High-Intensity Interval Training at 60% of MPO6, Other: Moderate-Intensity Continuous Training, Other: Supramaximal High-Intensity Interval Training at 80% of MPO6Healthy controls matched on age, sex and objectively measured physical activity (n = 16) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD with non-reversible airflow obstruction diagnosis (post-bronchodilator forced expiratory volume during the first second/forced vital capacity (FEV1/FVC) < 0.7)
- Age: > 40 years
- Age: > 40 years
Key exclusion criteria (10 listed)
- Recent exacerbation of COPD (< 6 weeks)
- Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
- Recent lung cancer (< 5 years)
- Unstable cardiac disease and/or cardiac stimulator
- HC
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 |
|---|---|---|
| Supramaximal High-Intensity Interval Training at 60% of MPO6Also: Supramaximal High-Intensity Interval Training at 60% of MPO6 (HIIT60%)Supramaximal HIIT is performed as 10×6 second intervals against a load of 60% of maximum mean power output for 6 seconds (MPO6) with a 54 second recovery between intervals. The MPO6 was estimated from the BCST. Duration supramaximal HIIT: 10 minutes Warm-up and cool-down: 5 minutes at 30% of maximum aerobic power (MAP) obtained during maximal incremental cardiopulmonary exercise test (CPET) on a stationary bicycle. | Other | Chronic Obstructive Pulmonary Disease (COPD), Healthy Controls (HC) |
| Moderate-Intensity Continuous TrainingAlso: MICTMICT is performed against a load of 60% of MAP obtained during a maximal incremental CPET on a stationary bicycle. Duration MICT: 20 minutes Warm-up and cool-down: 5 minutes at 30% of MAP obtained during maximal incremental CPET on a stationary bicycle. | Other | Chronic Obstructive Pulmonary Disease (COPD), Healthy Controls (HC) |
| Supramaximal High-Intensity Interval Training at 80% of MPO6Also: Supramaximal High-Intensity Interval Training at 80% of MPO6 (HIIT80%)Supramaximal HIIT is performed as 10×6 second intervals against a load of 80% of MPO6 with a 54 second recovery between intervals. The MPO6 was estimated from the BCST. Duration supramaximal HIIT: 10 minutes Warm-up and cool-down: 5 minutes at 30% of MAP obtained during maximal incremental CPET on a stationary bicycle. | Other | Chronic Obstructive Pulmonary Disease (COPD), Healthy Controls (HC) |
Primary outcome
Exercise intensity
Time frame: During visit 2 (week 1)
Produced watt at the set training intensity
Exercise intensity
Time frame: During visit 3 (week 2)
Produced watt at the set training intensity
Exercise intensity
Time frame: During visit 4 (week 2)
Produced watt at the set training intensity
Brain-derived neurotrophic factor (BDNF)
Time frame: During visit 2 (week 1)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
Brain-derived neurotrophic factor (BDNF)
Time frame: During visit 3 (week 2)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
Brain-derived neurotrophic factor (BDNF)
Time frame: During visit 4 (week 2)
Concentration of BDNF in obtained venous blood samples before, during and after exercise. Measured as ng/mL or pg/mL.
14 secondary outcomes
Cardiorespiratory demand
Time frame: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Venous blood lactate concentration
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Rating of perceived exertion
Time frame: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Rating of symptoms
Time frame: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Peripheral blood oxygen saturation (SpO2)
Time frame: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Blood pressure
Time frame: During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Circulating levels of neurotrophic factors
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Circulating levels of exerkines
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise session completion
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise preference
Time frame: At the end of visit 3 (week 2)
Session RPE
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise capacity
Time frame: During visit 1 (CPET; week 1)
Exercise intensity
Time frame: During visit 1 (BCST; week 1)
Adverse events
Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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 7 Jun 2023.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if individual participant data (IPD) will be available to other researchers.
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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.
Andre Nyberg, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supramaximal High-Intensity Interval Training at 60% of MPO6, Moderate-Intensity Continuous Training and Supramaximal High-Intensity Interval Training at 80% of MPO6 in people with COPD and Healthy Older Adults, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 10 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 7 Jun 2023. 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 Sweden. 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 intensity (time frame: During visit 2 (week 1)). The study lists 6 primary outcomes in all. 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 7 Jun 2023.