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

Rigshospitalet

Status: Enrolling

Conditions: Rehabilitation; COPD

Treatments: Behavioral: High Intensity Interval Training (HIIT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06551441

H-24021751

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Men and women

• Age >=40 and <80 years

• COPD (GOLD stage I to III)

• Modified Medical Research Council score (mMRC) of 0 to 3

• Resting arterial oxygenation > 90% Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Exercise

Experimental group

Description:

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

Treatment:

Behavioral: High Intensity Interval Training (HIIT)

Control group

No Intervention group

Description:

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