Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

Study Overview
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Brief Summary
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This RCT study aims to examine effects of a multidimensional exercise program in heart surgical patients. The following hypotheses were tested: patients who received the exercise program will report significant improvement in frailty, social support, anxiety and depression, quality of life after the 12-week program. Subjects are randomly assigned to the intervention or control group. Patients in the intervention group will receive a 12 week exercise program. Data are collected by physical indicators and a structural questionnaire to measure frailty, social support, anxiety and depression, quality of life, and nutritional assessment at baseline, 6 weeks, 12 weeks and 24 weeks after surgery.

Detailed Description
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This study aims to develop multidimensional exercise program, and examine the effects of an exercise program in heart surgical patients. An experimental design is used. Subjects are selected using a purposeful sampling and are randomly assigned to the intervention or control group by using block size randomization method. Patients in the intervention group will receive a 12 week exercise program including: individual consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls. Data are collected by physical indicators and a structural questionnaire to measure frailty, quality of life, social support, anxiety and depression, symptom distress at baseline, 6 weeks, 12 weeks and 24 weeks after surgery . Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t test, chi square, one way ANOVA and generalized estimating equation.

Official Title
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Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

Conditions
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Cardiac Surgery, Frailty

Intervention / Treatment
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* Behavioral: Multidimensional Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Aged above 40 and had received cardiac surgery. 2.Meet one of the Fried's phenotype of frailty. 3.Clear consciousness, can communicate with Chinese and Taiwanese. 4.Consent to join in this study. Exclusion Criteria: 1.Bed-ridden or unable to perform activities of daily living independently. 2.Unstable illness condition. 3.Emergency condition. 4.Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in the intervention group will receive a 12 week exercise program including: individual consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidimensional Exercise Program<br>Patients in this group will receive a 12 week exercise program including: (1) one 20-30 minute individual exercise consultation (teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls); (2) provided exercise booklet, exercise log, exercise video; (3) telephone follow-up once per week for 12 weeks. | Behavioral: Multidimensional Exercise Program<br>* Patients in experimental group will receive a 12 week exercise program; patients in control group maintain their usual life activities.<br>|
| No Intervention: Control group<br>Patients in this group maintain their daily life activities, and there is no intervention given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fried's Phenotype of Frailty scores | Changes from baseline Fried's Phenotype of Frailty scores including five indicators: weight loss, exhaustion, weakness, slowness, and low physical activity, at 6 weeks, 12 weeks, 24 weeks. Each indicator was identified as positive and negative. Frailty was defined if more than 2 indicators were positive. Pre-frailty was defined if one indicator was positive. | baseline, 6week, 12 week, 24week | 
| Changes in symptoms distress scores | Changes from baseline symptoms distress scale at 6 weeks, 12 weeks, 24 weeks. Symptoms distress scale contains 17 common symptoms items, each item use Likert scale five point scoring, the total scores ranged from 17 to 85, the higher scores indicate worse symptom distress. | baseline, 6week, 12 week, 24week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in health related quality of life (SF-12) scores | Changes from baseline SF-12 divide into Physical Health Composite scale(PCS) and Mental Health composite scale(MCS), and the total scores ranged from 0 to 100, the higher scores indicate better quality of life at 6 weeks, 12 weeks, 24 weeks. | baseline, 6 weeks, 12 weeks, 24 weeks | 
| Changes in anxiety and depression scores | Changes from baseline hospital anxiety and depression scale at 6 weeks, 12 weeks, 24 weeks. The hospital anxiety and depression scale contains 14 questions(7 for assess anxiety and 7 for assess depression), each item use Likert scale four point scoring, the total scores ranged from 0 to 21, the higher scores indicate more severe anxiety and depression level. | baseline, 6 weeks, 12 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Frailty, Exercise program