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Completed

NCT Number: NCT05874999

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:

1. 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). 2. To investigate the feasibility of supramaximal HIIT in people with COPD and matched HC. 3. 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Healthy Older Adults Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supramaximal High-Intensity Interval Training at 60% of MPO6

Other

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: Supramaximal High-Intensity Interval Training at 60% of MPO6 (HIIT60%)

Moderate-Intensity Continuous Training

Other

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: MICT

Supramaximal High-Intensity Interval Training at 80% of MPO6

Other

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: Supramaximal High-Intensity Interval Training at 80% of MPO6 (HIIT80%)

Primary outcomes

  1. Exercise intensity

    Time frame: During visit 2 (week 1)

    Produced watt at the set training intensity

  2. Exercise intensity

    Time frame: During visit 3 (week 2)

    Produced watt at the set training intensity

  3. Exercise intensity

    Time frame: During visit 4 (week 2)

    Produced watt at the set training intensity

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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)

    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.

  2. Venous blood lactate concentration

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    Measured before, during and after exercise.

  3. 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 perceived exertion scale (Borg RPE). Minimum value = 6 Maximum value = 20 A higher score means higher exertion.

  4. 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)

    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

  5. 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)

    SpO2 during exercise

  6. 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)

    Systolic and diastolic blood pressure during exercise

  7. Circulating levels of neurotrophic factors

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    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.

  8. Circulating levels of exerkines

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    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.

  9. Exercise session completion

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    Number of uninterrupted exercise sessions

  10. Exercise preference

    Time frame: At the end of visit 3 (week 2)

    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?"

  11. Session RPE

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    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

  12. Exercise capacity

    Time frame: During visit 1 (CPET; week 1)

    Maximal aerobic power (MAP) expressed as produced watt at VO2peak

  13. Exercise intensity

    Time frame: During visit 1 (BCST; week 1)

    Maximum mean power output for 30 seconds (MPO30) in watts

  14. Adverse events

    Time frame: During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

    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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Riksförbundet HjärtLung
  • Swedish Heart Lung Foundation
  • The Swedish Research Council

Registry information

Official study title

Feasibility and Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD

Acronym: COPD-HIIT-AC

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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