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

NCT04151836 | Completed

• 1 other identifier: 201901602A3
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Exercise

Keywords

Bariatric surgery; Body composition; Morbid obesity; Quality of life; Walking exercise

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Short Form 36(SF-36)

  baseline(one weeks after recruited)

• Short Form 36(SF-36)

  1st month after recruited

• Short Form 36(SF-36)

  2nd month after recruited

• Short Form 36(SF-36)

  3rd month after recruited

Study Arms (2)

exercise group

EXPERIMENTAL

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

control group

NO INTERVENTION

These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Interventions

Exercise education OTHER

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.

exercise group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (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.

  PMID: 23355293 RESULT

• 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.

  PMID: 27179520 RESULT

• 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.

  PMID: 18392907 RESULT

• 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.

  PMID: 26537198 RESULT

• 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.

  PMID: 28558160 RESULT

• 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.

  PMID: 21104041 RESULT

• 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.

  PMID: 28285470 RESULT

• 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.

  PMID: 20820940 RESULT

Related Links

• Obesity and overweight
• Adult obesity empirical guidelines

MeSH Terms

Conditions

Motor Activity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Mei Chen, PhD

  alice@ntunhs.edu.tw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A statistician who did not participate in the study randomly assigned patients to the experimental or control group according to the list generated by the computer software.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 5, 2019
• Study Start: January 9, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: June 11, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 12 months after publication
• Access Criteria: individual participant data that underline the results reported in this article,after deidentification(test,table,figures,and appendices)

Locations

TW (1)