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临床试验/NCT02213770
NCT02213770已完成不适用

Long Term Effect of High-intensity Training After Heart Transplantation

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
mean VO2peak in the intervention group and control group

研究概览

简要总结

High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study:

  1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
  2. Is the intervention group more physical active after HIT compared to the control group?

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

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

  • stable situation
  • optimal medical treatment
  • written concent

排除标准

  • unstable situation,
  • infections (open wounds or skin diseases),
  • physical conditions that prevents participation,
  • or other injuries/ diseases who are contraindicated with training.

结局指标

主要结局

mean VO2peak in the intervention group and control group

时间窗: 5 years after start of inclusion in RCT (TEX). One measurment.

We will use the same test protocol as the TEX- study.

次要结局

  • How many has progression of cardiac allograft vasculopathy in the intervention group and control group.(5 years after inclusion in RCT (TEX study).)
  • Mean muscle capacity in the intervention group and control group.(5 years after inclusion in RCT, TEX study.)
  • Difference in activity level between groups(5 years after inclusion i RCT, TEX study.)
  • Quality of life(5 years after inclusion in TEX- study.)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Yardley

Cand med

Oslo University Hospital

研究点 (1)

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