Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
2021년 6월 9일 업데이트: Chang Gung Memorial Hospital
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:
- The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.
- The quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
85
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taoyuan, 대만, 333
- Chang Gung Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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.
- 20-60 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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).
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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.
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간섭 없음: control group
These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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BMI
기간: baseline(one weeks after recruited)
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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baseline(one weeks after recruited)
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BMI
기간: 1st month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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1st month after recruited
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BMI
기간: 2nd month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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2nd month after recruited
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BMI
기간: 3rd month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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3rd month after recruited
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objective body composition index
기간: baseline(one weeks after recruited)
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using bioelectric impedance(BIA) to measure body composition
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baseline(one weeks after recruited)
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objective body composition index
기간: 1st month after recruited
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using bioelectric impedance(BIA) to measure body composition
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1st month after recruited
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objective body composition index
기간: 2nd month after recruited
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using bioelectric impedance(BIA) to measure body composition
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2nd month after recruited
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objective body composition index
기간: 3rd month after recruited
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using bioelectric impedance(BIA) to measure body composition
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3rd month after recruited
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Waistline and Waist to hip ratio
기간: baseline(one weeks after recruited)
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using a tape to measure Waistline and Waist to hip ratio.
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baseline(one weeks after recruited)
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Waistline and Waist to hip ratio
기간: 1st month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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1st month after recruited
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Waistline and Waist to hip ratio
기간: 2nd month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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2nd month after recruited
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Waistline and Waist to hip ratio
기간: 3rd month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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3rd month after recruited
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Short Form 36(SF-36)
기간: baseline(one weeks after recruited)
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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.
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baseline(one weeks after recruited)
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Short Form 36(SF-36)
기간: 1st month after recruited
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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.
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1st month after recruited
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Short Form 36(SF-36)
기간: 2nd month after recruited
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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.
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2nd month after recruited
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Short Form 36(SF-36)
기간: 3rd month after recruited
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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.
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3rd month after recruited
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Hui-Mei Chen, PhD, alice@ntunhs.edu.tw
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 1월 9일
기본 완료 (실제)
2021년 2월 23일
연구 완료 (실제)
2021년 2월 23일
연구 등록 날짜
최초 제출
2019년 11월 3일
QC 기준을 충족하는 최초 제출
2019년 11월 3일
처음 게시됨 (실제)
2019년 11월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 9일
마지막으로 확인됨
2020년 10월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
individual participant data that underline results in a publication
IPD 공유 기간
starting 12 months after publication
IPD 공유 액세스 기준
individual participant data that underline the results reported in this article,after deidentification(test,table,figures,and appendices)
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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