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

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.

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Other: Exercise education

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise group; 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; 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.
No Intervention: control group; These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Hui-Mei Chen, PhD, alice@ntunhs.edu.tw

Publications and helpful links

General Publications

• Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
• Robert M, Ferrand-Gaillard C, Disse E, Espalieu P, Simon C, Laville M, Gouillat C, Thivolet C. Predictive factors of type 2 diabetes remission 1 year after bariatric surgery: impact of surgical techniques. Obes Surg. 2013 Jun;23(6):770-5. doi: 10.1007/s11695-013-0868-4.
• 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.
• Woodlief TL, Carnero EA, Standley RA, Distefano G, Anthony SJ, Dubis GS, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Dose response of exercise training following roux-en-Y gastric bypass surgery: A randomized trial. Obesity (Silver Spring). 2015 Dec;23(12):2454-61. doi: 10.1002/oby.21332. Epub 2015 Nov 5.
• Carnero EA, Dubis GS, Hames KC, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Randomized trial reveals that physical activity and energy expenditure are associated with weight and body composition after RYGB. Obesity (Silver Spring). 2017 Jul;25(7):1206-1216. doi: 10.1002/oby.21864. Epub 2017 May 30.
• 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.
• 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.
• 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.

Helpful Links

• Obesity and overweight
• Adult obesity empirical guidelines

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): February 23, 2021
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Bariatric surgery; Body composition; Morbid obesity; Walking exercise
• Other Study ID Numbers: 201901602A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data that underline results in a publication
• IPD Sharing Time Frame: starting 12 months after publication
• IPD Sharing Access Criteria: individual participant data that underline the results reported in this article,after deidentification(test,table,figures,and appendices)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No