Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus
详细描述
A mixed method approach involving both qualitative and quantitative methods will be used.
The quantitative component will consist of a single blind, randomised controlled trial (RCT), which will explore the effects of the intervention on glycaemic control (blood sugar levels) and other secondary outcomes.
The qualitative component will consist of face to face interviews to explore the views of participants regarding acceptability and barriers affecting adherence to this intervention.
Potential participants will be informed about the study at hospital diabetes clinics, community health organisations, support groups, places of worship and General Practitioner (GP) surgeries. Recruitment is estimated to last for 9 months. Potential participants will be sent a participant information sheet (PIS) in either English or Urdu, depending on their preference. Those wishing to take part will meet the researcher at a convenient location, for eligibility screening and consent. If necessary, translation services can be arranged for those with limited English throughout the study.
Following baseline assessment, participants will be randomised to either the intervention or control group. Participants in the control group will be asked to continue their usual care and day to day physical activity routine. In addition, they will be given general information about diabetes management. Participants who wish to use the website for exercise will be provided with access at the end of all assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •define themselves as South Asians
- •BMI 21 - 29.9 kg/m2
- •diagnosed with Type 2 Diabetes Mellitus (T2DM) by a physician more than 6 months previously
- •access to a personal computer/tablet, smart phone or smart television with an email address and Internet connection
- •able to understand English or Urdu
排除标准
- •type 1 diabetes
- •any medical conditions that would affect adherence or contraindicate exercise including severe peripheral neuropathy, severe autonomic neuropathy, severe physical limitations, heart disease, pre-proliferative or proliferative retinopathy, uncontrolled hypertension (>180/ 100mmHg), or coronary artery disease.
- •people using insulin if they do not have a self-monitoring glucose device or are unable to use such devices.
- •engaging in exercise training of 150 minutes a week or more
- •participating in other interventional studies aiming to improve glycaemic control
- •unwilling to be randomised
研究组 & 干预措施
Control group
Usual care
Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
干预措施: Web-based exercise programme (Behavioral)
结局指标
主要结局
Glycaemic control
时间窗: Baseline to 12 weeks
Change in HbA1c
次要结局
- Blood lipid profile (low-density lipoproteins)(12 weeks to 20 weeks)
- Body mass index (BMI)(12 weeks to 20 weeks)
- Blood lipid profile (triglyceride)(12 weeks to 20 weeks)
- Blood pressure(12 weeks to 20 weeks)
- Blood lipid profile (cholesterol)(12 weeks to 20 weeks)
- Blood lipid profile (high density lipoproteins)(12 weeks to 20 weeks)
- Timed Up and Go test(12 weeks to 20 weeks)
- Muscle power(12 weeks to 20 weeks)
- Quality of Life - WHO-QOL BREF score(12 weeks to 20 weeks)
- Adherence - exercise diary completion(12 weeks)
- Change in Medication(12 weeks to 20 weeks)
- Waist circumference(12 weeks to 20 weeks)
- Dietary intake(12 weeks to 20 weeks)
- Glycaemic control(12 weeks to 20 weeks)
- Ten metre walking test (10MWT)(12 weeks to 20 weeks)
- Blood lipid profile (cholesterol)(Baseline to 12 weeks)
- Blood lipid profile (high density lipoproteins)(Baseline to 12 weeks)
- Blood lipid profile (low-density lipoproteins)(Baseline to 12 weeks)
- Blood lipid profile (triglyceride)(Baseline to 12 weeks)
- Ten metre walking test (10MWT)(Baseline to 12 weeks)
- Blood pressure(Baseline to 12 weeks)
- Body mass index (BMI)(Baseline to 12 weeks)
- Waist circumference(Baseline to 12 weeks)
- Timed Up and Go test(Baseline to 12 weeks)
- Muscle power(Baseline to 12 weeks)
- Quality of Life - WHO-QOL BREF score(Baseline to 12 weeks)
- Dietary intake(Baseline to 12 weeks)
- Change in Medication(Baseline to 12 weeks)