- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05874999
Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD (COPD-HIIT-AC)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Umeå, Sweden
- Umeå University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
COPD
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion Criteria:
- Age: > 40 years
Exclusion Criteria:
- Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Chronic Obstructive Pulmonary Disease (COPD)
People with chronic obstructive pulmonary disease (COPD) (n = 16)
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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 Names:
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.
Other Names:
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 Names:
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Active Comparator: Healthy Controls (HC)
Healthy controls matched on age, sex and objectively measured physical activity (n = 16)
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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 Names:
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.
Other Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise intensity
Time Frame: During visit 2 (week 1)
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Produced watt at the set training intensity
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During visit 2 (week 1)
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Exercise intensity
Time Frame: During visit 3 (week 2)
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Produced watt at the set training intensity
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During visit 3 (week 2)
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Exercise intensity
Time Frame: During visit 4 (week 2)
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Produced watt at the set training intensity
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During visit 4 (week 2)
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Brain-derived neurotrophic factor (BDNF)
Time Frame: During visit 2 (week 1)
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Concentration of BDNF in obtained venous blood samples before, during and after exercise.
Measured as ng/mL or pg/mL.
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During visit 2 (week 1)
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Brain-derived neurotrophic factor (BDNF)
Time Frame: During visit 3 (week 2)
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Concentration of BDNF in obtained venous blood samples before, during and after exercise.
Measured as ng/mL or pg/mL.
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During visit 3 (week 2)
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Brain-derived neurotrophic factor (BDNF)
Time Frame: During visit 4 (week 2)
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Concentration of BDNF in obtained venous blood samples before, during and after exercise.
Measured as ng/mL or pg/mL.
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During visit 4 (week 2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Venous blood lactate concentration
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Measured before, during and after exercise.
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
|
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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)
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Rating of perceived exertion scale (Borg RPE).
Minimum value = 6 Maximum value = 20 A higher score means higher exertion.
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During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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)
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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
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During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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)
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SpO2 during exercise
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During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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)
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Systolic and diastolic blood pressure during exercise
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During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Circulating levels of neurotrophic factors
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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.
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Circulating levels of exerkines
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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.
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Exercise session completion
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Number of uninterrupted exercise sessions
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
|
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Exercise preference
Time Frame: At the end of visit 3 (week 2)
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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?" |
At the end of visit 3 (week 2)
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Session RPE
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Exercise capacity
Time Frame: During visit 1 (CPET; week 1)
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Maximal aerobic power (MAP) expressed as produced watt at VO2peak
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During visit 1 (CPET; week 1)
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Exercise intensity
Time Frame: During visit 1 (BCST; week 1)
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Maximum mean power output for 30 seconds (MPO30) in watts
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During visit 1 (BCST; week 1)
|
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Adverse events
Time Frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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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.
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During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: André Nyberg, PhD, Umeå University
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
Other Study ID Numbers
- COPD-HIIT ACUTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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