Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD
NCT Number: NCT06551441
Acronym: COPDEX
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD|Rehabilitation
Interventions: BEHAVIORAL: High Intensity Interval Training (HIIT)
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: Center For Physical Activity Research, Rigshospitalet, Copenhagen, Denmark

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.

Primary Outcome Measures: 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 Outcome Measures: DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest, 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), 6 months|Total LTM (g), Difference in change from baseline to six months between groups in total LTM (g), 6 months
Other Outcome Measures: DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative), 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), 6 months|DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute), 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), 6 months|Pulmonary blood volume / total blood volume ratio, Difference in change from baseline to six months between groups in pulmonary blood volume / total blood volume ratio, 6 months|Health-related quality of life - COPD Assessment Test (CAT) score, Difference in change from baseline to six months between groups in health-related quality of life, 6 months|Health-related quality of life - St. George's Respiratory Questionnaire (SGRQ), Difference in change from baseline to six months between groups in health-related quality of life, 6 months|Lobar LTM (g), Difference in change from baseline to six months between groups in lobar LTM (g), 6 months|LTM/1.73 m2 BSA (g/m2), Difference in change from baseline to six months between groups in LTM/1.73 m2 BSA (g/m2), 6 months|Total blood volume, Difference in change from baseline to six months between groups in total blood volume, 6 months|DL,NO (mmol/(min kPa)) during upright rest, Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during upright rest, 6 months|DL,CO,5s (mmol/(min kPa)) during upright rest, Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during upright rest, 6 months|Pulmonary capillary blood volume (VC, mL) during upright rest, Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during upright rest, 6 months|Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest, Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest, 6 months|DL,NO (mmol/(min kPa)) during supine rest, Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during supine rest, 6 months|DL,CO,5s (mmol/(min kPa)) during supine rest, Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during supine rest, 6 months|Pulmonary capillary blood volume (VC, mL) during supine rest, Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during supine rest, 6 months|Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest, Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest, 6 months|Cardiac output (L/min) during exercise, 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, 6 months|DL,CO,NO-based V̇O2 during exercise, 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, 6 months|V̇O2peak, 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 (%), 6 months|Time constant (s), Difference in change from baseline to six months between groups in time constant from V̇O2kinetic test, 6 months|Amplitude (ml/kg^-1/min^-1), Difference in change from baseline to six months between groups in amplitude measured by V̇O2kinetic test, 6 months|Time delay (s), Difference in change from baseline to six months between groups in time delay measured by V̇O2kinetic test, 6 months|Hand-grip strength (kg), Difference in change from baseline to six months between groups in hand-grip strength (kg), 6 months|Sit-to-stand test (n), Difference in change from baseline to six months between groups in numbers of completed 30 seconds sit-to-stand test (n), 6 months|Body composition:, 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 (%), 6 months|Lung function, 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), 6 months|6-minute walking test, Difference in change in the distance (m) walked from baseline to six months between groups in a 6-minute walking test, 6 months|Blood samples, 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)), 6 months|Mean bolus transit time (s) (supine rest), Difference in change from baseline to six months between groups in mean bolus transit time (s) (supine rest), 6 months|Mean bolus transit time (s) (adenosine infusion), Difference in change from baseline to six months between groups in mean bolus transit time (s) (adenosine infusion), 6 months|Global coronary flow reserve (mL/min), Difference in change from baseline to six months between groups in global coronary flow reserve (mL/min), 6 months|Pulmonary blood volume reserve (mL), Difference in change from baseline to six months between groups in pulmonary blood volume reserve (mL), 6 months|Left ventricular ejection fraction (%), Difference in change from baseline to six months between groups in left ventricular ejection fraction (%), 6 months|Cardiac output (L/min) (supine rest), Difference in change from baseline to six months between groups in cardiac output (L/min) (supine rest), 6 months|Cardiac output (L/min) (adenosine infusion), Difference in change from baseline to six months between groups in cardiac output (L/min) (adenosine infusion), 6 months|Total plasma volume, Difference in change from baseline to six months between groups in total plasma volume, 6 months|Red blood cells, Difference in change from baseline to six months between groups in red blood cells, 6 months|Coronary calcium score, Difference in change from baseline to six months between groups in coronary calcium score, 6 months|Intima-media thickness (IMT) in the common carotid artery (mm), Difference in change from baseline to six months between groups in intima-media thickness (IMT) in the common carotid artery (mm), 6 months|Blood samples, 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), 6 months|Resistance (Rrs, R5-R20), Difference in change from baseline to six months between groups in resistance (Rrs, R5-R20) measured by IOS, 6 months|Reactance (Xrs, X5), Difference in change from baseline to six months between groups in reactance (Xrs, X5) measured by IOS, 6 months