Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD

NCT06551441 | Recruiting DMC

• 1 other identifier: H-24021751
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective randomised controlled trial in which the impact of high intensity interval training (HIIT) on pulmonay blood volume, pulmonary gas exchange during exercise, and lung tissue mass. The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange. Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue. Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue, symptom severity, pulmonary gas exchange at supine rest and on pulmonary blood volume at rest. Finally, exploratory objectives include investigating the effects of HIIT on lung function, V̇O2peak, functional outcomes, body composition, blood samples and cardiac output. Participants will be randomly allocated (1:1) stratified by sex to either

1. 1.24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
2. 2.A control group who will not undergo HIIT training. The control group will be encouraged not to change their exercise or eating habits.

Conditions

COPD; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Pulmonary blood volume (mL) at rest

  Difference in change from baseline to six months between groups in pulmonary blood volume (mL) at rest

  6 months

Secondary Outcomes (2)

• DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest

  6 months

• Total LTM (g)

  6 months

Other Outcomes (42)

• DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative)

  6 months

• DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute)

  6 months

• Pulmonary blood volume / total blood volume ratio

  6 months

Study Arms (2)

Exercise

EXPERIMENTAL

The HIIT intervention includes three supervised sessions per week over a 24-week period i.e., 72 exercise sessions and take place at CFAS or at home with supervision

Behavioral: High Intensity Interval Training (HIIT)

Control group

NO INTERVENTION

Controls will be encouraged to maintain current exercise habits for the duration of the study.

Interventions

High Intensity Interval Training (HIIT) BEHAVIORAL

The HIIT intervention consist of 4 intervals with each lasting 4 minutes (4x4min). If a participant reports discomfort related to the length of the intervals or start to feel unmotivated by performing the same exercise, we will use another HIIT protocol: 10x1min. The 4x4min HIIT consists of a warm-up period of 10 minutes with a target heart rate at 60-70% of HRmax, followed by 4 HIIT intervals with a target HR ≥85%. The intervals are separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following this, a cool down period of three minutes at warm up intensity is performed. The 10x1min HIIT consists of a 10-minute warm-up period.The warm-up is followed by 10 intervals, each lasting 1 min at 100% of maximal workload, separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following the intervals, a cool down period of three minutes at warm up intensity is performed.

Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Age \>=40 and \<80 years
• COPD (GOLD stage I to III)
• Modified Medical Research Council score (mMRC) of 0 to 3

You may not qualify if:

• Symptoms of ischaemic heart disease
• Known heart failure
• Unable to complete or understand HIIT training
• Claudication
• Symptoms of disease within 2 weeks prior to the study
• Participation in pulmonary rehabilitation within 3 months
• Known malignant disease
• Pregnancy
• Unstable cardiac arrhythmic disease
• Renal or liver dysfunction
• Known chronic kidney or liver disease
• Elevated creatinine, urea, alanine transaminase (ALAT), aspartate transaminase (ASAT), bilirubin, basic phosphatases at blood test
• Completion of pulmonary rehabilitation within the last 3 months

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center For Physical Activity Research, Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Iben E Rasmussen, MSc

CONTACT

61698192; iben-er@hotmail.com

Ronan Berg, MD, DMSc

CONTACT

35451825; ronan.martin.griffin.berg@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Associate Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: August 13, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

DK (1)