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

Not Applicable

Recruiting

• Conditions: Rehabilitation; COPD
• Interventions: Behavioral: High Intensity Interval Training (HIIT)

• Registration Number: NCT06551441
• Lead Sponsor: Rigshospitalet, Denmark

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. 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or

2. A control group who will not undergo HIIT training. The control group will be encouraged not to change their exercise or eating habits.

The participants will visit the clinic pre- and post the intervention. Exercise habits, adverse events, hospital admisseions, infections and medications will be assessed by phone at week 4, 8, 12, 16, 20 and at follow-up visit. All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior. The devices will be attached just before the randomization, after one month, at 12 weeks and just before the 6 months testing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	High Intensity Interval Training (HIIT)	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

Primary Outcome Measures

Name	Time	Method
Pulmonary blood volume (mL) at rest	6 months	Difference in change from baseline to six months between groups in pulmonary blood volume (mL) at rest

Secondary Outcome Measures

Name	Time	Method
Total LTM (g)	6 months	Difference in change from baseline to six months between groups in total LTM (g)
DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest	6 months	Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest, 60% of current maximal workload (relative), and at follow-up including 60% of maximal workload at baseline (absolute)

Trial Locations

Locations (1)

Center For Physical Activity Research, Rigshospitalet; 🇩🇰 Copenhagen, Denmark