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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151836
• Other study ID #: 201901602A3
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: February 23, 2021

Study information

• Verified date: October 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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 — View Citation

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 — View Citation

Castello V, Simões 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/s11695-0 — View 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. — View 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. — View Citation

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. — View Citation

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/s11 — View Citation

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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	objective body composition index	using bioelectric impedance(BIA) to measure body composition	baseline(one weeks after recruited)
Primary	objective body composition index	using bioelectric impedance(BIA) to measure body composition	1st month after recruited
Primary	objective body composition index	using bioelectric impedance(BIA) to measure body composition	2nd month after recruited
Primary	objective body composition index	using bioelectric impedance(BIA) to measure body composition	3rd month after recruited
Primary	Waistline and Waist to hip ratio	using a tape to measure Waistline and Waist to hip ratio.	baseline(one weeks after recruited)
Primary	Waistline and Waist to hip ratio	using a tape to measure Waistline and Waist to hip ratio.	1st month after recruited
Primary	Waistline and Waist to hip ratio	using a tape to measure Waistline and Waist to hip ratio.	2nd month after recruited
Primary	Waistline and Waist to hip ratio	using a tape to measure Waistline and Waist to hip ratio.	3rd month after recruited
Secondary	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)
Secondary	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
Secondary	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
Secondary	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

External Links

•   Adult obesity empirical guidelines
•   Obesity and overweight