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临床试验/NCT06552390
NCT06552390已完成不适用

Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)

Instituto Politécnico de Bragança2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1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
30
试验地点
2
主要终点
Functional Capacity - Evaluation of the 6-minute walk test (6MWT)

研究概览

简要总结

To evaluate the safety and efficacy of the phase 1 cardiac rehabilitation protocol(HRN4HTx) in heart transplant patients, focusing on self-care capacity and functionalrecovery.

详细描述

Type of study: Descriptive and Interventional Study

  • Location: Centro Hospitalar e Universitário de Coimbra, Cardiothoracic Surgery Unit

Study Population:

  • Inclusion Criteria: Heart transplant patients, over 18 years of age, capable of providing informed consent.
  • Exclusion Criteria: Rejection 2R, inability to understand due to cognitive impairment, external ventricular assistance, infectious processes with hemodynamic changes.

Intervention:

研究设计

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

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

  • Heart transplant patients, over 18 years of age, capable of providing informedconsent.

排除标准

  • Rejection 2R
  • Inability to understand due to cognitive impairment
  • External ventricular assistance
  • Infectious processes with hemodynamic changes

结局指标

主要结局

Functional Capacity - Evaluation of the 6-minute walk test (6MWT)

时间窗: At the date of discharge (mean days of hospitalization of 15 until a maximum of days 21)

6-minute walk test (6MWT), higher value means better outcome (no maximum value)

Self-Care Capacity - Evaluation of the Barthel Index

时间窗: At the date of admission and at the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)

Barthel Index, from 0 to 100, higher scores means better outcome

Knowledge of Risk Factors - Evaluation of knowledge regarding alarm signs and cardiovascular risk factors

时间窗: At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)

Knowledge regarding alarm signs and cardiovascular risk factors, from 0 to 100%, higher value means better outcome

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

André Filipe Morais Pinto Novo

Coordinator Professor

Instituto Politécnico de Bragança

研究点 (2)

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