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NCT Number: NCT04332887

Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged above 40 years old and received cardiac surgery via median sternotomy with a stable physical condition;
  • at least met one of the frailty phenotypes, including unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity proposed by Fried et al. (2001);
  • had clear consciousness (Mini-Mental State Examination score>24) and can communicate with Mandarin or Taiwanese;
  • consent to participate in this study.

Exclusion criteria

  • bed-ridden, cannot stand or depends on others to complete all activities of daily living;
  • received emergency cardiac surgery;
  • with a mental illness history;
  • had exercise contraindications including: in infectious or acute phases, uncontrolled hypertension, arrhythmia, or diabetes mellitus;
  • had a musculoskeletal disease, which might be aggravated by exercise;
  • participate in phase two of cardiac rehabilitation.

Treatment and study plan

Multidimensional Exercise Program

Behavioral

Patients in the experimental group will receive a 12-week multidimensional exercise program; patients in the control group will maintain their usual life activities.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2020
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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