此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Assessment of Exercise Intensity in Cardiac Rehabilitation Programmes for Patients With Chronic Heart Failure

2012年3月6日 更新者:Guy Lloyd

Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic heart failure (CHF), since it addresses the complex interplay of medical, psychological and behavioural factors facing these individuals. Structured exercise training within a cardiac rehabilitation programme is firmly recommended for these patients. However, it is questionable whether patients are achieving an adequate dose of exercise to provide optimal benefits. The essential components for setting optimal training include the appropriate mode, duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation describe the frequency and duration of training, but here is scant information on exercise intensity. However, it is apparent that randomised controlled trials of exercise training use doses more than 4 times greater than in UK current practice. The Eastbourne Exercise Cardiology Research Group has demonstrated that although patients benefit from improved quality of life and submaximal fitness after a hospital outpatient cardiac rehabilitation programme, they do not achieve the increases in important prognostic indicators reported by the majority of exercise training trials.

The critical factor in terms of eliciting a sufficient training effect while minimising risk is the intensity of the exercise performed. It is now widely accepted that the traditional methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise intensity include serious errors. The European Society of Cardiology recommends that cardiopulmonary exercise testing should be used to provide an objective evaluation of the metabolic demand of exercise. This allows physiologically meaningful reference points to be established for aerobic exercise prescription and is the solution to defining safe and effective training intensities. The next step is to determine whether this information can be transferred to a practical cardiac rehabilitation environment to set and monitor exercise intensity

研究概览

地位

未知

条件

详细说明

Background Heart failure is a chronic, costly and life-threatening disorder that constitutes a significant burden for individuals and the National Health Service [There are 27,000 new cases reported per annum in the UK. Cardiac rehabilitation (CR) is recommended as the ideal comprehensive intervention since it addresses the complex interplay of medical, psychological and behavioural factors facing CHF patients and carers.

Study Aim Primary objective to describe the exercise intensity, defined by oxygen uptake (VO2) in terms of the individual physiological thresholds, in CHF patients undergoing CR according to current guidelines Primary end point: VO2 Secondary objectives Secondary objectives of this study are:-

  1. To measure resting and exercising energy expenditure in order to a) establish the value of 1 MET (resting metabolic rate) for patients with CHF, and b) to establish the MET value (defined as multiples of resting metabolic rate) for exercises performed in CR sessions
  2. To measure affective responses (feeling very bad - feeling very good; levels of energy - tiredness and tension - calmness) to exercise during CR sessions
  3. To measure weekly physical activity level in CHF patients undergoing Phase III and IV CR.

For the secondary analysis the following secondary end points and parameters will be established

  1. MET values, defined as multiples of resting oxygen uptake or resting metabolic rate (1 MET), for different CR exercises
  2. Ratings of affective response on the Feelings Scale (FS) and ratings of perceived activation on the Felt Arousal Scale (FAS).
  3. Average daily activity over 7 day period in terms of steps per day and periods spent sitting, standing and walking

研究类型

观察性的

注册 (预期的)

21

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • East Sussex
      • Eastbourne、East Sussex、英国、BN21 2UD
        • Eastbourne General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

21 CHF patients from Heart Failure clinic at Eastbourne District General Hospital

描述

Inclusion criteria:

  • Systolic heart failure with resting left ventricular ejection fraction below 40%
  • New York Heart Association (NYHA) class I-III
  • clinically stable for at least 4 weeks on optimised medication dosage according to current guidelines

Exclusion criteria:

  • Acute coronary syndrome within past 6 months
  • Untreated lifethreatening cardiac arrhythmias
  • Acute heart failure (during initial period of haemodynamic instability)
  • Uncontrolled hypertension
  • Advanced atrioventricular block
  • Acute myocarditis or pericarditis
  • Symptomatic aortic stenosis
  • Severe hypertrophic obstructive cardiomyopathy
  • Acute systemic illness Intracardiac thrombus
  • Progressive worsening of exercise tolerance of dyspnoea at rest over previous 35 days
  • Significant ischaemia during low intensity exercise (< 2 METS, < 50W)
  • Uncontrolled diabetes
  • Recent embolism
  • Thrombophlebitis
  • New onset atrial fibrillation/flutter
  • > 1.8 kg increase in body mass over previous 13 days
  • Concurrent, continuous or intermittent dobutamine therapy
  • Decrease in systolic blood pressure with exercise
  • NYHA Functional Class IV
  • Complex ventricular arrhythmia at rest or appearing with exertion
  • Supine resting heart rate > 100 beats/min
  • Patient is participating in a conflicting study, is unable to perform exercise testing
  • Patient lacks the capacity to consent or cannot comply with study requirements

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The primary outcome measure is the oxygen uptake(VO2)during exercise
大体时间:13 weeks
13 weeks

次要结果测量

结果测量
措施说明
大体时间
Affective responses (e.g. feelings of pleasure/displeasure)
大体时间:13 weeks
Questionnaire used to measure affective responses (Feelings Scale, Felt Anxiety Scale and Activation/Deactivation )
13 weeks
Weekly physical activity
大体时间:13 weeks
Average daily physical activity: Participants' freeliving activity will be classified by ActivPAL into periods spent sitting, standing and walking, and daily energy expenditure will also be estimated from this information.
13 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Guy W Lloyd, MD、Eastbourne General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (预期的)

2013年4月1日

研究完成 (预期的)

2013年4月1日

研究注册日期

首次提交

2012年2月29日

首先提交符合 QC 标准的

2012年2月29日

首次发布 (估计)

2012年3月6日

研究记录更新

最后更新发布 (估计)

2012年3月7日

上次提交的符合 QC 标准的更新

2012年3月6日

最后验证

2012年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TN11-26

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

心脏衰竭的临床试验

3
订阅