Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients

Study Overview
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Brief Summary
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This study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in Taiwan. Hypothesis: The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month. The quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.

Detailed Description
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This study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in Taiwan.

Official Title
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Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients

Conditions
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Exercise

Intervention / Treatment
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* Other: Exercise education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After the research purpose is stated, the subject agrees and is willing to participate in the researcher and is willing to sign a written consent form. 20-60 years old, with clear consciousness, can communicate with the Mandarin and Taiwanese, and are willing to conduct this research. Body mass index according to the Asia Pacific implementation of Bariatric surgery indications, BMI≧37 Kg/m2 or BMI≧32 Kg/m2 combined with metabolic diseases caused by obesity, such as cardiovascular disease, type 2 diabetes, Obstructive Sleep Apnea(OSA), nonalcoholic fatty liver, and degenerative arthritis. Patients with morbid obesity undergoing laparoscopic gastric sleeve resection or laparoscopic gastric bypass surgery. Explain how the smart phone application (Google Fit) and (68 Heart Rate Monitor) are used, and the patient or family member can be operated after returning home. Exclusion Criteria: After the attending physician evaluates,medical order presentation a person who cannot perform exercise prescriptions. Lower limb limb disorders or amputations cannot coordinate with exercise prescription. Poorly controlled cardiovascular diseases such as arrhythmia, angina, heart failure,myocardial infarction, and chest pain during activities or rest in the past three months. Patients with poor diabetes control, glycosylated hemoglobin (HbA1C) > 9%, with eye lesions or neuropathy. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg when quiet. Heart rate is greater than 100bpm when quiet.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Both groups were tested by demographic characteristics, dietary behavior measurement, SF-36 Questionnaire and body composition analyzer for the same project. The experimental group needs to cooperate with the moderate-intensity walking exercise training prescription for 3 times a week ; Control group no exercise intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise group<br>exercise education: A 12-week regimen of home-based walking exercises, include moderate intensity 30 minutes of exercise in week 1-4,40 minutes of exercise in 5-8 weeks,50 minutes in the 9-12 week,three times weekly in three month.We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 65%-70% of the target Maximal heart rate(HRmax). | Other: Exercise education<br>* weekly telephone or mobile application LINE consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.<br>|
| No Intervention: control group<br>These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2) | baseline(one weeks after recruited) | 
| BMI | using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2) | 1st month after recruited | 
| BMI | using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2) | 2nd month after recruited | 
| BMI | using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2) | 3rd month after recruited | 
| objective body composition index | using bioelectric impedance(BIA) to measure body composition | baseline(one weeks after recruited) | 
| objective body composition index | using bioelectric impedance(BIA) to measure body composition | 1st month after recruited | 
| objective body composition index | using bioelectric impedance(BIA) to measure body composition | 2nd month after recruited | 
| objective body composition index | using bioelectric impedance(BIA) to measure body composition | 3rd month after recruited | 
| Waistline and Waist to hip ratio | using a tape to measure Waistline and Waist to hip ratio. | baseline(one weeks after recruited) | 
| Waistline and Waist to hip ratio | using a tape to measure Waistline and Waist to hip ratio. | 1st month after recruited | 
| Waistline and Waist to hip ratio | using a tape to measure Waistline and Waist to hip ratio. | 2nd month after recruited | 
| Waistline and Waist to hip ratio | using a tape to measure Waistline and Waist to hip ratio. | 3rd month after recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36(SF-36) | The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living. | baseline(one weeks after recruited) | 
| Short Form 36(SF-36) | The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living. | 1st month after recruited | 
| Short Form 36(SF-36) | The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living. | 2nd month after recruited | 
| Short Form 36(SF-36) | The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living. | 3rd month after recruited | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Body composition, Morbid obesity, Quality of life, Walking exercise