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

June 5, 2023 updated by: Andre Nyberg, Umeå University

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:

  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.

Study Overview

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

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Umeå, Sweden
        • Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Chronic Obstructive Pulmonary Disease (COPD)
People with chronic obstructive pulmonary disease (COPD) (n = 16)

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%)

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 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)

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%)

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 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise intensity
Time Frame: During visit 2 (week 1)
Produced watt at the set training intensity
During visit 2 (week 1)
Exercise intensity
Time Frame: During visit 3 (week 2)
Produced watt at the set training intensity
During visit 3 (week 2)
Exercise intensity
Time Frame: During visit 4 (week 2)
Produced watt at the set training intensity
During visit 4 (week 2)
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.
During visit 2 (week 1)
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.
During visit 3 (week 2)
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.
During visit 4 (week 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Measured before, during and after exercise.
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 perceived exertion scale (Borg RPE). Minimum value = 6 Maximum value = 20 A higher score means higher exertion.
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)
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
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)
SpO2 during exercise
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)
Systolic and diastolic blood pressure during exercise
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)
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.
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)
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.
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)
Number of uninterrupted exercise sessions
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)

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)
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
During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Exercise capacity
Time Frame: During visit 1 (CPET; week 1)
Maximal aerobic power (MAP) expressed as produced watt at VO2peak
During visit 1 (CPET; week 1)
Exercise intensity
Time Frame: During visit 1 (BCST; week 1)
Maximum mean power output for 30 seconds (MPO30) in watts
During visit 1 (BCST; week 1)
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.
During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: André Nyberg, PhD, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

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)?

UNDECIDED

IPD Plan Description

Undecided: It is not yet known if individual participant data (IPD) will be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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