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

COPD Clinical Trial

— COPD-HIIT-AC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874999
• Other study ID #: COPD-HIIT ACUTE
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: June 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Healthy Older Adults

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Riksförbundet HjärtLung, Swedish Heart Lung Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise intensity	Produced watt at the set training intensity	During visit 2 (week 1)
Primary	Exercise intensity	Produced watt at the set training intensity	During visit 3 (week 2)
Primary	Exercise intensity	Produced watt at the set training intensity	During visit 4 (week 2)
Primary	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)
Primary	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)
Primary	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	Cardiorespiratory demand	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)
Secondary	Venous blood lactate concentration	Measured before, during and after exercise.	During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Secondary	Rating of perceived exertion	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)
Secondary	Rating of symptoms	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)
Secondary	Peripheral blood oxygen saturation (SpO2)	SpO2 during exercise	During visit 1 (CPET and BCST; week 1), visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Secondary	Blood pressure	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)
Secondary	Circulating levels of neurotrophic factors	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)
Secondary	Circulating levels of exerkines	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)-a, 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)
Secondary	Exercise session completion	Number of uninterrupted exercise sessions	During visit 2 (week 1), visit 3 (week 2) and visit 4 (week 2)
Secondary	Exercise preference	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)
Secondary	Session RPE	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)
Secondary	Exercise capacity	Maximal aerobic power (MAP) expressed as produced watt at VO2peak	During visit 1 (CPET; week 1)
Secondary	Exercise intensity	Maximum mean power output for 30 seconds (MPO30) in watts	During visit 1 (BCST; week 1)
Secondary	Adverse events	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)