COPD-HIIT-AC: Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD

Sponsor
Umeå University (Other)
Overall Status
Completed
CT.gov ID
NCT05874999
Collaborator
The Swedish Research Council (Other), Swedish Heart Lung Foundation (Other), Riksförbundet HjärtLung (Other)
32
1
2
9.5
3.4

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 3):

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

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility and Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD
Actual Study Start Date :
Mar 7, 2022
Actual Primary Completion Date :
Dec 22, 2022
Actual Study Completion Date :
Dec 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chronic Obstructive Pulmonary Disease (COPD)

People with chronic obstructive pulmonary disease (COPD) (n = 16)

Other: Supramaximal High-Intensity Interval Training at 60% of MPO6
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%)
  • Other: Moderate-Intensity Continuous Training
    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
  • Other: Supramaximal High-Intensity Interval Training at 80% of MPO6
    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%)
  • Active Comparator: Healthy Controls (HC)

    Healthy controls matched on age, sex and objectively measured physical activity (n = 16)

    Other: Supramaximal High-Intensity Interval Training at 60% of MPO6
    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%)
  • Other: Moderate-Intensity Continuous Training
    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
  • Other: Supramaximal High-Intensity Interval Training at 80% of MPO6
    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%)
  • Outcome Measures

    Primary Outcome Measures

    1. Exercise intensity [During visit 2 (week 1)]

      Produced watt at the set training intensity

    2. Exercise intensity [During visit 3 (week 2)]

      Produced watt at the set training intensity

    3. Exercise intensity [During visit 4 (week 2)]

      Produced watt at the set training intensity

    4. Brain-derived neurotrophic factor (BDNF) [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) [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) [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 Outcome Measures

    1. Cardiorespiratory demand [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 [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 [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 [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) [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 [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 [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 [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 [During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)]

      Number of uninterrupted exercise sessions

    10. Exercise preference [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 [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 [During visit 1 (CPET; week 1)]

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

    13. Exercise intensity [During visit 1 (BCST; week 1)]

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

    14. Adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Umeå University Umeå Sweden

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Andre Nyberg, PhD, Umeå University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andre Nyberg, Associate Professor, Umeå University
    ClinicalTrials.gov Identifier:
    NCT05874999
    Other Study ID Numbers:
    • COPD-HIIT ACUTE
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andre Nyberg, Associate Professor, Umeå University

    Study Results

    No Results Posted as of May 25, 2023