A Feasibility Randomised Controlled Trial to Investigate the Effects of a 12-week Digital Physical Activity Programme, With or Without Physical Education Support, on Blood Glucose Control in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- HbA1c testing
研究概览
简要总结
Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.
详细描述
Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of T2DM in the last 3 years.
- •Age 18+ years.
- •Uses the English language as a primary or secondary language with the ability to read and write.
- •Lives in the United Kingdom.
- •Has no medical reason preventing participation in regular physical activity.
- •Has a SMART phone with access to the internet.
排除标准
- •Physical inability to participate in 12 weeks of physical activity.
- •Cardiac or cardiovascular surgery in the past 6 months.
- •Musculoskeletal issues that could be aggravated whilst participating in regular physical activity.
- •Presently participating in a weight loss programme.
- •Unable to commit to the 12-week feasibility study.
结局指标
主要结局
HbA1c testing
时间窗: 12 weeks
blood will be take pre and post trial.
次要结局
- Cholesterol ratio testing(12 weeks)
研究者
Phil Calvert
Principal Investigator
Queen Margaret University