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临床试验/NCT06551441
NCT06551441招募中不适用

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

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
Pulmonary blood volume (mL) at rest

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pulmonary blood volume (mL) at rest

时间窗: 6 months

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronan Berg

MD, DMSc, Associate Professor

Rigshospitalet, Denmark

研究点 (1)

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