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临床试验/NCT03545802
NCT03545802已完成不适用

A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study

Liverpool John Moores University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Compliance over the course of the training programme

研究概览

简要总结

This study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • duration of type 1 diabetes >6 months,
  • no significant history of hyper- or hypoglycaemia

排除标准

  • duration of type 1 diabetes <6 months,
  • significant history of hyper- or hypoglycaemia,
  • pregnancy or planning pregnancy,
  • uncontrolled hypertension (>180/100 mmHg),
  • autonomic neuropathy,
  • taking any medication that affects heart rate (HR)
  • major surgery planned within 6 weeks of the study
  • severe nonproliferative
  • unstable proliferative retinopathy

结局指标

主要结局

Compliance over the course of the training programme

时间窗: compliance to the training programme over the course of the 6 week intervention

ability to meet target heart rates (compliance) was assessed

adherence over the course of the training programme

时间窗: adherence to the training programme over the course of the 6 week intervention

session completion rate (adherence) was assessed

change in maximal aerobic capacity

时间窗: change in baseline maximal aerobic capacity at 6 weeks

Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer

次要结局

  • change in insulin sensitivity(change in baseline insulin sensitivity at 6 weeks)
  • change in glycaemic control(change in baseline glycaemic control at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sam Shepherd

Lecturer/Senior Lecturer, Principle Investigator

Liverpool John Moores University

研究点 (2)

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Home-HIT and Type 1 Diabetes | 临床试验