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临床试验/NCT05398744
NCT05398744进行中(未招募)不适用

MIGHTEE: Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
2
主要终点
Study feasibility assessed by participants' engagement with exercise physiologist

研究概览

简要总结

The aim of this 16-week group aerobic training program, delivered remotely via video-conferencing, is to assess program feasibility, and determine if program increases physical activity in adolescents after heart transplant.

详细描述

Orthotopic heart transplant (OHT) is the definitive therapy for children with cardiac disease, however, survival after transplant is limited, and quality of life after transplant is less than healthy peers'. The transplanted heart usually works well, pumping blood as well as most healthy hearts. As such, the American Heart Association recommends no specific exercise related restrictions for heart transplant recipients. Although most children have normal cardiac function after OHT, children with transplanted hearts have impaired exercise performance, and do not exercise as much as their peers. This finding is concerning, as impaired exercise tolerance is associated with reduced survival, diminished health related quality of life, and depression and anxiety. These factors negatively impact adherence, and further limit graft survival. Thus, identifying interventions that positively impact physical activity and promote graft longevity, like individualized exercise programs, should be a priority for post-transplant care.

Investigators propose that increasing physical activity in children and adolescents after OHT may be a critical modifiable method for increasing graft longevity and improving quality of life. Investigators will explore this through a pilot program. Participants will wear an activity monitor to record physical activity, parents/caregivers and participants will complete surveys, and participants will engage with psychologists and exercise physiologists.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Study feasibility assessed by participants' engagement with exercise physiologist

时间窗: 24 weeks

Participants' attendance at biweekly meetings with exercise physiologist

Study feasibility assessed by participation in training sessions

时间窗: 16 weeks

Attendance at assigned training sessions

Study feasibility evaluated by participants' engagement on the activity monitor application

时间窗: 24 weeks

Days of logged activity on the MyHeart application

次要结局

  • Participants' overall program satisfaction(24 weeks)
  • Health Related Quality of life(24 weeks)
  • Psychological well-being(24 weeks)
  • Physical activity of participants(24 weeks)
  • Perceived exercise barriers or exercise barriers(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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