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NCT Number: NCT06551441

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center For Physical Activity Research, Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Location contact

Iben E Rasmussen, MSc

CONTACT

[email protected]

61698192

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pulmonary blood volume (mL) at rest

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 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)

  2. Total LTM (g)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in total LTM (g)

Other outcomes

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

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative)

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

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute)

  3. Pulmonary blood volume / total blood volume ratio

    Time frame: 6 months

    Difference in change from baseline to six months between groups in pulmonary blood volume / total blood volume ratio

  4. Health-related quality of life - COPD Assessment Test (CAT) score

    Time frame: 6 months

    Difference in change from baseline to six months between groups in health-related quality of life

  5. Health-related quality of life - St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in health-related quality of life

  6. Lobar LTM (g)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in lobar LTM (g)

  7. LTM/1.73 m2 BSA (g/m2)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in LTM/1.73 m2 BSA (g/m2)

  8. Total blood volume

    Time frame: 6 months

    Difference in change from baseline to six months between groups in total blood volume

  9. DL,NO (mmol/(min kPa)) during upright rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during upright rest

  10. DL,CO,5s (mmol/(min kPa)) during upright rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during upright rest

  11. Pulmonary capillary blood volume (VC, mL) during upright rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during upright rest

  12. Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest

  13. DL,NO (mmol/(min kPa)) during supine rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during supine rest

  14. DL,CO,5s (mmol/(min kPa)) during supine rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during supine rest

  15. Pulmonary capillary blood volume (VC, mL) during supine rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during supine rest

  16. Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest

    Time frame: 6 months

    Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest

  17. Cardiac output (L/min) during exercise

    Time frame: 6 months

    Difference in change from baseline to six months between groups in cardiac output (L/min) during exercise at 60% of current maximal workload and 60% of baseline maximal workload, in the supine position, and during upright rest

  18. DL,CO,NO-based V̇O2 during exercise

    Time frame: 6 months

    DL,CO,NO-based V̇O2 during exercise at 60% of current maximal workload and 60% of baseline maximal workload, in the supine position, and during upright rest

  19. V̇O2peak

    Time frame: 6 months

    Difference in change from baseline to six months between groups in relative (mL/kg/min) and absolute (mL/min) V̇O2peak, ventilatory threshold (%), and ventilatory reserve (%)

  20. Time constant (s)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in time constant from V̇O2kinetic test

  21. Amplitude (ml/kg^-1/min^-1)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in amplitude measured by V̇O2kinetic test

  22. Time delay (s)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in time delay measured by V̇O2kinetic test

  23. Hand-grip strength (kg)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in hand-grip strength (kg)

  24. Sit-to-stand test (n)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in numbers of completed 30 seconds sit-to-stand test (n)

  25. Body composition:

    Time frame: 6 months

    Difference in change from baseline to six months between groups in body composition: total mass (kg), total fat mass (kg and %), lean body mass (kg), fat percentage (%)

  26. Lung function

    Time frame: 6 months

    Difference in change from baseline to six months between groups in lung function: FEV1 (L and %pred), FVC (L and %pred), RV (L and %pred), TLC (L and %pred), single-breath diffusion capacity to carbon monoxide (mmol/(min kPa) and %pred)

  27. 6-minute walking test

    Time frame: 6 months

    Difference in change in the distance (m) walked from baseline to six months between groups in a 6-minute walking test

  28. Blood samples

    Time frame: 6 months

    Difference in change from baseline to six months between groups in exercise-induced cytokine responses (interleukin-6 (pg/mL), tumour necrosis factor-α (pg/mL), C-reactive protein (μg/mL), interleukin-8 (pg/mL), and interleukin-10 (pg/mL))

  29. Mean bolus transit time (s) (supine rest)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in mean bolus transit time (s) (supine rest)

  30. Mean bolus transit time (s) (adenosine infusion)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in mean bolus transit time (s) (adenosine infusion)

  31. Global coronary flow reserve (mL/min)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in global coronary flow reserve (mL/min)

  32. Pulmonary blood volume reserve (mL)

    Time frame: 6 months

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

  33. Left ventricular ejection fraction (%)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in left ventricular ejection fraction (%)

  34. Cardiac output (L/min) (supine rest)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in cardiac output (L/min) (supine rest)

  35. Cardiac output (L/min) (adenosine infusion)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in cardiac output (L/min) (adenosine infusion)

  36. Total plasma volume

    Time frame: 6 months

    Difference in change from baseline to six months between groups in total plasma volume

  37. Red blood cells

    Time frame: 6 months

    Difference in change from baseline to six months between groups in red blood cells

  38. Coronary calcium score

    Time frame: 6 months

    Difference in change from baseline to six months between groups in coronary calcium score

  39. Intima-media thickness (IMT) in the common carotid artery (mm)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in intima-media thickness (IMT) in the common carotid artery (mm)

  40. Blood samples

    Time frame: 6 months

    Difference in change from baseline to six months between groups in blood samples: lipids (cholesterol (mmol/l), LDL (mmol/l), HDL (mmol/l)), HbA1C (mmol/l), HsCRP (mg/L), pro-BNP (pmol/L), and TSH (10-3 IU/L)

  41. Resistance (Rrs, R5-R20)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in resistance (Rrs, R5-R20) measured by IOS

  42. Reactance (Xrs, X5)

    Time frame: 6 months

    Difference in change from baseline to six months between groups in reactance (Xrs, X5) measured by IOS

Study contacts

Contact information is provided by the study sponsor or research team.

Iben E Rasmussen, MSc

CONTACT

[email protected]

61698192

Ronan Berg, MD, DMSc

CONTACT

[email protected]

35451825

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD: a Randomized Controlled Trial (the COPDEX Study)

Acronym: COPDEX

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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