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临床试验/NCT05273684
NCT05273684已完成不适用

High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Exercise tolerability: Subjective rating of the exercise session

研究概览

简要总结

Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.

详细描述

12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols.

Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Men and women
  • 18-80 years
  • Moderate to severe COPD(GOLD stage II to III)

排除标准

  • Known ischaemic heart disease
  • Known heart failure
  • Previous or current coronavirus disease 2019 (COVID-19)
  • Dementia or other severe neurological disease
  • Known vascular
  • Symptoms of disease within 2 weeks prior to the study
  • Pregnancy

结局指标

主要结局

Exercise tolerability: Subjective rating of the exercise session

时间窗: 1 week

Tolerability is measured with a 10-point Likert scale, where the participants evaluate the two HIIT protocols. They will anser two quesitens: 1. How tolerable was todays traning? 2. How much did you enjoy todays training? Where 1 means not at all, and 10 means alot. The Likert scale is scored as: Red: 1-2 Amber: 3-4 Green: +5

Exercise feasibility: Relative dose intensity (RDI) of exercise

时间窗: 1 week

RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100 Evaluated with a Red-Amber-Green system: * Green: If ≥85% of the training is completed * Amber: If 50-85% of the training is completed * Red: If ≤ 50% of the training is completed

Exercise feasibility: Exercise sessions attendance rate

时间窗: 1 week

Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

Exercise feasibility: Exercise sessions requiring dose modifications

时间窗: 1 week

Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.

次要结局

未报告次要终点

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 (2)

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