- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03545802
Home-HIT and Type 1 Diabetes
A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
연구 개요
상세 설명
This study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.
Eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2; V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. Adherence and ability to meet target heart rate (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application. Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. A qualitative online survey was completed post-training.
This is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Merseyside
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Liverpool, Merseyside, 영국, L3 3AF
- Liverpool John Moores University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- duration of type 1 diabetes >6 months,
- no significant history of hyper- or hypoglycaemia
Exclusion Criteria:
- duration of type 1 diabetes <6 months,
- significant history of hyper- or hypoglycaemia,
- pregnancy or planning pregnancy,
- uncontrolled hypertension (>180/100 mmHg),
- angina
- autonomic neuropathy,
- taking any medication that affects heart rate (HR)
- major surgery planned within 6 weeks of the study
- severe nonproliferative
- unstable proliferative retinopathy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Training
6 weeks of home-based high intensity interval training
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Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change in maximal aerobic capacity
기간: change in baseline maximal aerobic capacity at 6 weeks
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Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer
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change in baseline maximal aerobic capacity at 6 weeks
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adherence over the course of the training programme
기간: adherence to the training programme over the course of the 6 week intervention
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session completion rate (adherence) was assessed
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adherence to the training programme over the course of the 6 week intervention
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Compliance over the course of the training programme
기간: compliance to the training programme over the course of the 6 week intervention
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ability to meet target heart rates (compliance) was assessed
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compliance to the training programme over the course of the 6 week intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change in insulin sensitivity
기간: change in baseline insulin sensitivity at 6 weeks
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insulin dose was recorded pre and post training by participants
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change in baseline insulin sensitivity at 6 weeks
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change in glycaemic control
기간: change in baseline glycaemic control at 6 weeks
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participants recorded their blood glucose concentrations in the first and final weeks of the intervention
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change in baseline glycaemic control at 6 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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. .
Home-HIT에 대한 임상 시험
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University of AdelaideRoyal Adelaide Hospital; University of South Australia종료됨
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University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg완전한
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Göteborg UniversitySahlgrenska University Hospital, Sweden완전한
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University Health Network, Toronto모병림프종 | 림프 증식 장애 | 유방암 1기 | 유방암 2기 | 대장암 2기 | 대장암 3기 | 유방암 3기 | 대장암 1기 | 두경부암 3기 | 유방암, 0기 | 두경부암 1기 | 두경부암 2기캐나다
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Alberto Pilotto완전한
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한