Clinical trial NCT06551441: Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD
Official title: Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD: a Randomized Controlled Trial (the COPDEX Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Rehabilitation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pulmonary blood volume (mL) at rest
timeFrame: 6 months
Secondary outcomes:
measure: DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest
timeFrame: 6 months
measure: Total LTM (g)
timeFrame: 6 months
Other outcomes:
measure: DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative)
timeFrame: 6 months
measure: DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute)
timeFrame: 6 months
measure: Pulmonary blood volume / total blood volume ratio
timeFrame: 6 months
measure: Health-related quality of life - COPD Assessment Test (CAT) score
timeFrame: 6 months
measure: Health-related quality of life - St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 6 months
measure: Lobar LTM (g)
timeFrame: 6 months
measure: LTM/1.73 m2 BSA (g/m2)
timeFrame: 6 months
measure: Total blood volume
timeFrame: 6 months
measure: DL,NO (mmol/(min kPa)) during upright rest
timeFrame: 6 months
measure: DL,CO,5s (mmol/(min kPa)) during upright rest
timeFrame: 6 months
measure: Pulmonary capillary blood volume (VC, mL) during upright rest
timeFrame: 6 months
measure: Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest
timeFrame: 6 months
measure: DL,NO (mmol/(min kPa)) during supine rest
timeFrame: 6 months
measure: DL,CO,5s (mmol/(min kPa)) during supine rest
timeFrame: 6 months
measure: Pulmonary capillary blood volume (VC, mL) during supine rest
timeFrame: 6 months
measure: Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest
timeFrame: 6 months
measure: Cardiac output (L/min) during exercise
timeFrame: 6 months
measure: DL,CO,NO-based V̇O2 during exercise
timeFrame: 6 months
measure: V̇O2peak
timeFrame: 6 months
measure: Time constant (s)
timeFrame: 6 months
measure: Amplitude (ml/kg^-1/min^-1)
timeFrame: 6 months
measure: Time delay (s)
timeFrame: 6 months
measure: Hand-grip strength (kg)
timeFrame: 6 months
measure: Sit-to-stand test (n)
timeFrame: 6 months
measure: Body composition:
timeFrame: 6 months
measure: Lung function
timeFrame: 6 months
measure: 6-minute walking test
timeFrame: 6 months
measure: Blood samples
timeFrame: 6 months
measure: Mean bolus transit time (s) (supine rest)
timeFrame: 6 months
measure: Mean bolus transit time (s) (adenosine infusion)
timeFrame: 6 months
measure: Global coronary flow reserve (mL/min)
timeFrame: 6 months
measure: Pulmonary blood volume reserve (mL)
timeFrame: 6 months
measure: Left ventricular ejection fraction (%)
timeFrame: 6 months
measure: Cardiac output (L/min) (supine rest)
timeFrame: 6 months
measure: Cardiac output (L/min) (adenosine infusion)
timeFrame: 6 months
measure: Total plasma volume
timeFrame: 6 months
measure: Red blood cells
timeFrame: 6 months
measure: Coronary calcium score
timeFrame: 6 months
measure: Intima-media thickness (IMT) in the common carotid artery (mm)
timeFrame: 6 months
measure: Blood samples
timeFrame: 6 months
measure: Resistance (Rrs, R5-R20)
timeFrame: 6 months
measure: Reactance (Xrs, X5)
timeFrame: 6 months
Locations:
city: Copenhagen
country: Denmark
facility: Center For Physical Activity Research, Rigshospitalet
Study officials:
References: