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
- 1
- 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.
研究组 & 干预措施
Intervention 1
Intervention 1, will be provided with a 12 week PA programme and asked to record their PA while they follow the programme during the 12 week study.
干预措施: HbA1c testing (Diagnostic Test)
Control Group,
Control Group, will be issued with a smartwatch that is paired with a freely accessible App called Alexia® to record their PA. They will be asked to carry on with their daily activity and to record when they do any of their own physical activities that they do themselves routinely on an everyday basis during the 12 week study. They will not receive a 12 week PA programme.
Intervention 2
Intervention 2, will also be provided with the same 12 week PA program and asked to record their PA while they follow the programme during the 12 week study. The participants in this group will also get support from a physical activity professional (PAP) who will be monitoring their 12 week journey. The PAP will be prompting the participant with weekly information as to why they are doing these exercises as well as supporting the participants to continue their programme as soon as non-adherence to the exercise program becomes apparent during the 12 week study.
干预措施: HbA1c testing (Diagnostic Test)
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