Clinical trial NCT04151836: Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
Official title: Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: Bariatric surgery
Body composition
Morbid obesity
Quality of life
Walking exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: baseline(one weeks after recruited)
measure: BMI
timeFrame: 1st month after recruited
measure: BMI
timeFrame: 2nd month after recruited
measure: BMI
timeFrame: 3rd month after recruited
measure: objective body composition index
timeFrame: baseline(one weeks after recruited)
measure: objective body composition index
timeFrame: 1st month after recruited
measure: objective body composition index
timeFrame: 2nd month after recruited
measure: objective body composition index
timeFrame: 3rd month after recruited
measure: Waistline and Waist to hip ratio
timeFrame: baseline(one weeks after recruited)
measure: Waistline and Waist to hip ratio
timeFrame: 1st month after recruited
measure: Waistline and Waist to hip ratio
timeFrame: 2nd month after recruited
measure: Waistline and Waist to hip ratio
timeFrame: 3rd month after recruited
Secondary outcomes:
measure: Short Form 36(SF-36)
timeFrame: baseline(one weeks after recruited)
measure: Short Form 36(SF-36)
timeFrame: 1st month after recruited
measure: Short Form 36(SF-36)
timeFrame: 2nd month after recruited
measure: Short Form 36(SF-36)
timeFrame: 3rd month after recruited
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: alice@ntunhs.edu.tw
name: Hui-Mei Chen, PhD
role: STUDY_CHAIR
References:
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citation: Janik MR, Rogula T, Bielecka I, Kwiatkowski A, Pasnik K. Quality of Life and Bariatric Surgery: Cross-Sectional Study and Analysis of Factors Influencing Outcome. Obes Surg. 2016 Dec;26(12):2849-2855. doi: 10.1007/s11695-016-2220-2.
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citation: Castello V, Simoes RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4.
citation: Campanha-Versiani L, Pereira DAG, Ribeiro-Samora GA, Ramos AV, de Sander Diniz MFH, De Marco LA, Soares MMS. The Effect of a Muscle Weight-Bearing and Aerobic Exercise Program on the Body Composition, Muscular Strength, Biochemical Markers, and Bone Mass of Obese Patients Who Have Undergone Gastric Bypass Surgery. Obes Surg. 2017 Aug;27(8):2129-2137. doi: 10.1007/s11695-017-2618-5.
citation: Kolotkin RL, LaMonte MJ, Litwin S, Crosby RD, Gress RE, Yanowitz FG, Hunt SC, Adams TD. Cardiorespiratory fitness and health-related quality of life in bariatric surgery patients. Obes Surg. 2011 Apr;21(4):457-64. doi: 10.1007/s11695-010-0261-5.