NCT05874999

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

March 30, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

Acute ExerciseHigh-intensity Interval Training

Outcome Measures

Primary Outcomes (6)

  • Exercise intensity

    Produced watt at the set training intensity

    During visit 2 (week 1)

  • Exercise intensity

    Produced watt at the set training intensity

    During visit 3 (week 2)

  • Exercise intensity

    Produced watt at the set training intensity

    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.

    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.

    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.

    During visit 4 (week 2)

Secondary Outcomes (14)

  • Cardiorespiratory demand

    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

    During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

  • 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 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)

    During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)

  • +9 more secondary outcomes

Study Arms (2)

Chronic Obstructive Pulmonary Disease (COPD)

EXPERIMENTAL

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

Other: Supramaximal High-Intensity Interval Training at 60% of MPO6Other: Moderate-Intensity Continuous TrainingOther: 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)

Other: Supramaximal High-Intensity Interval Training at 60% of MPO6Other: Moderate-Intensity Continuous TrainingOther: Supramaximal High-Intensity Interval Training at 80% of MPO6

Interventions

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.

Also known as: Supramaximal High-Intensity Interval Training at 60% of MPO6 (HIIT60%)
Chronic Obstructive Pulmonary Disease (COPD)Healthy Controls (HC)

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.

Also known as: MICT
Chronic Obstructive Pulmonary Disease (COPD)Healthy Controls (HC)

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.

Also known as: Supramaximal High-Intensity Interval Training at 80% of MPO6 (HIIT80%)
Chronic Obstructive Pulmonary Disease (COPD)Healthy Controls (HC)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \- Age: \> 40 years
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andre Nyberg, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 25, 2023

Study Start

March 7, 2022

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations