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

Not Applicable

Completed

• Conditions: Exercise
• Interventions: Other: Exercise education

• Registration Number: NCT04151836
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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:

1. The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.

2. The quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Study First Posted: 2019-11-05
• Study Start: 2020-01-09
• Status Verified: 2020-10
• Primary Completion: 2021-02-23
• Study Completion: 2021-02-23
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. 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.
2. 20-60 years old, with clear consciousness, can communicate with the Mandarin and Taiwanese, and are willing to conduct this research.
3. 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.
4. Patients with morbid obesity undergoing laparoscopic gastric sleeve resection or laparoscopic gastric bypass surgery.
5. 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

1. After the attending physician evaluates,medical order presentation a person who cannot perform exercise prescriptions.
2. Lower limb limb disorders or amputations cannot coordinate with exercise prescription.
3. Poorly controlled cardiovascular diseases such as arrhythmia, angina, heart failure,myocardial infarction, and chest pain during activities or rest in the past three months.
4. Patients with poor diabetes control, glycosylated hemoglobin (HbA1C) > 9%, with eye lesions or neuropathy.
5. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg when quiet.
6. Heart rate is greater than 100bpm when quiet.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise group	Exercise education	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).

Primary Outcome Measures

Name	Time	Method
Waistline and Waist to hip ratio	3rd month after recruited	using a tape to measure Waistline and Waist to hip ratio.
BMI	3rd month after recruited	using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
objective body composition index	3rd month after recruited	using bioelectric impedance(BIA) to measure body composition

Secondary Outcome Measures

Name	Time	Method
Short Form 36(SF-36)	3rd month after recruited	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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan