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临床试验/NCT06113133
NCT06113133已完成不适用

Assessment of Maximal Oxygen Uptake in Persons Enrolled in Exercise-based Cardiac Rehabilitation

VIA University College1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
1
主要终点
Maximal oxygen uptake

研究概览

简要总结

To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. This plateau will be examined for the purpose of assessing VO2 max in persons enrolled in exercise-based cardiac rehabilitation. Furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau.

Heart disease and characteristics for all participants are obtained. Participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. This included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (BORG6-20).

详细描述

Oxygen uptake is measured breath-by-breath by a cardiopulmonary exercise test (CPET), and oxygen and carbon dioxide sensors were calibrated before each test along with the flow sensor, there was calibrated with a 3-litre syringe.

To examine the primary aim, the incidence of a plateau in oxygen uptake was examined by comparing the moving average of the last 15 consecutive breaths with the penultimate 15 breaths and cut-offs at <50 ml and <100 ml of oxygen.

Secondary criteria; Respiratory exchange ratio (RER max), Rating of perceived exertion (BORG RPE max) and heart rate (HR max) are examined to determine if the participant performs the exercise test with a maximal effort to exertion. The respiratory exchange ratio (VCO2/VO2) using age-depending RER cut-offs; 1.10 for ages 40-59 years, 1.06 for ages 60-69 years and +70 years to determine if a maximal effort is provided. There are no recommendations for RER cut-off when participants are aged above 69 years. Therefore, they must reach the RER cut-off 1.06 to be evaluated as maximal effort.

The rating of perceived exertion using the BORG RPE 6-20 scale evaluation > 17 is considered maximal effort. The test was supervised by experienced physiotherapists, an in-house nurse supported if necessary, and a physician was available upon request. Participants and physiotherapists were blinded for VO2 max results from CPET. CPET gas exchange system was operated by an experienced researcher.

Maximal heart rate is rated as a maximal effort by cut-offs calculated as 208 - (0.7 x age in years) according to age group. Using respectively, > 92% and > 89% of the calculated HR max for the age group 40-59 years and the age groups 60-69 years and +70 years to consider maximal effort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included

排除标准

  • heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.

结局指标

主要结局

Maximal oxygen uptake

时间窗: Pretest is conducted at the first day in rehabilitation. Posttest is conducted when a participant finish rehabilitation or maximal 1 week after the end of the rehabilitation after 12-weeks

Cardiopulmonary exercise test by Metalyzer 3B to determine maximal oxygen uptake measured in millimetre oxygen

次要结局

  • Respiratory exchange ratio(Respiratory exchange ratio is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.)
  • Ratio of perceived exertion(The participants rate their perceived exertion immediately after CPET is finished at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.)
  • Maximal heart rate(Heart rate is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.)

研究者

发起方
VIA University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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