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临床试验/NCT04332887
NCT04332887已完成不适用

Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2019年6月2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
92
试验地点
2
主要终点
Changes in Fried's Phenotype of Frailty Status and Frailty Criteria

研究概览

简要总结

This randomized controlled trial study aims to examine the effects of a multidimensional exercise program in cardiac surgery patients. The following hypotheses were tested: patients who received the exercise program will report significant improvement in frailty after the 12-week multidimensional exercise program. Subjects are randomly assigned to the intervention or control group. Patients in the intervention group will receive a 12-week multidimensional exercise program. Data are collected by using medical records and structural questionnaires, measuring handgrip strength, and a four-meter walk test at baseline, 6 weeks, and 12 weeks.

详细描述

This study aims to develop a multidimensional exercise program and examine the effects of an exercise program on cardiac surgery patients. An experimental design is used. Subjects are recruited using convenience sampling and randomly assigned to the intervention or control group using the block randomization method. Patients in the intervention group will receive a 12-week multidimensional exercise program, including individual nursing consultation, an exercise program that includes moderate intensity walking for 30-45 minutes per day, three days per week combined resistance exercise, nutrition assessment, and instructions, and support. Data are collected by using medical records and structural questionnaires, measuring handgrip strength, and a four-meter walk test at baseline, 6 weeks, and 12 weeks. The data were analyzed using SPSS version 22.0, and data analysis methods include descriptive statistics, independent t-test, chi-square, and generalized estimating equation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.

入排标准

年龄范围
40 Years 至 —(Adult, Older 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

Changes in Fried's Phenotype of Frailty Status and Frailty Criteria

时间窗: baseline, 6week, 12 week

Changes from baseline Fried's Phenotype of Frailty include five criteria: weight loss, exhaustion, weakness, slowness, and low physical activity at baseline, 6 weeks, and 12 weeks. Each criteria was identified as positive and negative. Frail was defined if more than two criteria were positive. Pre-frail was defined if one criteria was positive.

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

Ai-Fu Chiou

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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