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临床试验/NCT01480921
NCT01480921已完成不适用

The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure

McMaster University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Change in health-related quality of life (HRQL): Generic and disease specific

研究概览

简要总结

The objective of this study is to compare the effect of monitored, home-based exercise versus hospital-based exercise on the quality of life of patients with congestive heart failure. Secondary objectives are to assess the effect of the intervention on exercise capacity and caregiver burden.

The investigators hypothesize that the exercise training in the home-based environment will be superior to hospital based exercise training.

详细描述

Congestive heart failure (CHF) is a chronic disease that is associated with enormous burden of illness. Patients with CHF have diminished health-related quality of life, and due to the high demand associated with their everyday activities and self-management, there is consequently a burden upon family caregivers. Though exercise is a component of clinical practice guidelines for the management of CHF, previous studies have not examined the interrelationships among changes in exercise capacity, health-related quality of life (HRQL) and important predictor variables such as self-efficacy, as a result of exercise training in CHF patients. Furthermore, research to date has failed to examine whether a hospital-based or a home-based approach to exercise is the best-suited strategy for long-term adoption and benefit from exercise training. Thus, the most important effective approach to, and environment for, exercise training to improve the health and self-management of CHF patients has not yet been determined. This study will address some important gaps in the existing literature related to the benefits of exercise in CHF, specifically how different exercise approaches and strategies contribute to an individual's HRQL and self-efficacy.

This is a prospective, randomized controlled trial using a two-group, repeated measures design. Male and female patients with New York Heart Association (NYHA) Functional Class I-III CHF will be eligible to participate. Participants will be randomized to receive either supervised, hospital-based exercise or monitored home-based exercise. The participants in the study will train for a period of six months and will be reassessed six months following completion of the intervention to assess sustainability of any observed changes.

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
Single (Outcomes Assessor)

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

  • chronic stable heart failure
  • NYHA class I, II or III
  • willing and able to regularly attend a supervised exercise program
  • provision of written, informed consent

排除标准

  • unstable angina in the last month
  • recent acute MI (last 3 months) which precipitated heart failure
  • hospitalized for heart failure in past month
  • severe chronic pulmonary disease (FEV1 <40%)
  • uncontrolled hypertension (B/P >140/90)
  • orthopedic, neurological or psychiatric illness precluding participation in exercise
  • heart failure that is amenable to revascularization, which is planned in the near future
  • NYHA class IV

结局指标

主要结局

Change in health-related quality of life (HRQL): Generic and disease specific

时间窗: baseline, 3 months, 6 months, one year

The Medical Outcomes Short Form-36 will be used to measure generic HRQL. The Minnesota Living with Heart Failure (MLQHF) Questionnaire will be used to measure disease specific HRQL.

次要结局

  • Change in exercise capacity (peak exercise oxygen uptake - VO2)(baseline, 3 months, 6 months, one year)
  • Change in self-efficacy for exercise(baseline, 3 months, 6 months, one year)
  • Change in caregiver burden(baseline, 3 months, 6 months, one year)

研究者

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

Heather Arthur

Principal Investigator

McMaster University

研究点 (2)

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