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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое High Intensity Interval Training (HIIT)
  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 sh

Первичные конечные точки

• Pulmonary blood volume (mL) at rest [Срок оценки: 6 months]

Вторичные конечные точки (2)

• DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest [Срок оценки: 6 months]
• Total LTM (g) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Center For Physical Activity Research, Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT06551441 · H-24021751

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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