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临床试验/NCT04903691
NCT04903691已完成不适用

Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery

Yale University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年5月15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
9
试验地点
2
主要终点
Change in functional fitness.

研究概览

简要总结

This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.

详细描述

Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.

排除标准

  • Patients may be excluded for inability to read or understand English
  • suffering from a condition that precludes informed consent (for example, cardiogenic shock)
  • hemodynamic instability
  • ongoing trauma or substance overdoses
  • known intellectual or developmental delay
  • communication impairment
  • active users of illicit substances
  • active psychiatric illness
  • inability to attend cardiac rehabilitation (homeless, in police custody, or living out of state)
  • inability to exercise (lower limb amputation, bedridden, decompensated heart failure, ongoing cancer treatment)

结局指标

主要结局

Change in functional fitness.

时间窗: Baseline and 2 weeks after completing exercise program

Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness)

Change in cardiorespiratory fitness

时间窗: Baseline and 2 weeks after completing exercise program

Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness)

Change in strength

时间窗: Baseline and 2 weeks after completing exercise program

Change in strength as measured by grip strength (Higher values indicate better strength).

Change in cognition

时间窗: Baseline and 2 weeks after completing exercise program

Measured by standardized tests of cognition such as Montreal Cognitive Assessment (MoCA) (Higher values indicate better cognition with scores less than 23-26 adjusting for education indicative of impaired cognition)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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