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Clinical Trials/NCT04332887
NCT04332887
Completed
N/A

Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

National Yang Ming Chiao Tung University1 site in 1 country92 target enrollmentJune 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
National Yang Ming Chiao Tung University
Enrollment
92
Locations
1
Primary Endpoint
Changes in Fried's Phenotype of Frailty Status and Frailty Criteria
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2019
End Date
March 11, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ai-Fu Chiou

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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