- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02175810
Impact of Bariatric Surgery on Cardiorespiratory Function
Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.
Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.
The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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London, 영국, SW17 0RE
- 모병
- St George's Healthcare NHS Trust
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연락하다:
- Dimitra Nikoletou
- 전화번호: +44 20 8725 5647
- 이메일: dinikole@sgul.ac.uk
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부수사관:
- Emma R McGlone
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부수사관:
- Ommar A Khan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Ages 18 years to 50 years
- Patients enrolled in the bariatric surgery program of St George's Hospital with BMI > 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes
Exclusion Criteria:
- Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing
- Weight > 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)
- Cognitive impairment
- Patients unable to follow instructions in English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
기간: One to two weeks before surgery and six months after surgery
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One to two weeks before surgery and six months after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Lung function
기간: One to two weeks before surgery and six months after surgery
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Lung function will be assessed by spirometry and body plethysmography
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One to two weeks before surgery and six months after surgery
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Heart function
기간: One to two weeks before surgery and six months after surgery
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Echocardiography will be performed to assess heart function.
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One to two weeks before surgery and six months after surgery
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Inspiratory muscle strength
기간: One to two weeks before surgery and six months after surgery
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Maximal inspiratory pressure and sniff nasal pressure will be recorded.
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One to two weeks before surgery and six months after surgery
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Peripheral muscle strength
기간: One to two weeks before surgery and six months after surgery
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Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
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One to two weeks before surgery and six months after surgery
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Free living sedentary and physical activity times
기간: One to two weeks before surgery and six months after surgery
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Daily physical activity habits will be assessed by an accelerometer and International Physical Activity Questionnaire: Long (IPAQ-Long).
Participants will be required to wear the accelerometer for four consecutive days during the two study points.
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One to two weeks before surgery and six months after surgery
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Marcia S Volpe, Universidade Federal Triangulo Mineiro
- 연구 의자: Dimitra Nikoletou, Kingston University and St George's University of London
- 연구 책임자: Marcus Reddy, St George's Healthcare NHS Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .