Effect of a Community-based Sport Programme on Disease Symptoms and Quality of Life in Men and Women With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 4,032
- 试验地点
- 2
- 主要终点
- Change from baseline in number of participants reporting one or more sessions of sport per week measured by the UK Single Item Questionnaire
研究概览
简要总结
The Fit4Life intervention aims to engage inactive patients with type 2 diabetes in a community-based sport intervention, with the aim being that all participants complete 1 x 30 min session of physical activity/exercise per week across the 12 months they are involved in the intervention (total study duration 3 years).
The aim of the Fit4Life intervention is to slow the progression of disease symptoms and to improve quality of life in those diagnosed with type 2 diabetes. The aim of this research study is thus to evaluate the effectiveness of the intervention in achieving these aims. The hypothesis is that involvement in the Fit4Life programme will increase physical activity, reduce type 2 diabetes disease symptoms and enhance self-reported quality of life in male and female patients aged 35-64.
详细描述
Overview The evaluation will also assess the effect of the community-based sport intervention (1 x 30 min session per week) on physical activity levels and cognitive function in type 2 diabetes patients. Physical activity is known to assist in the management of type 2 diabetes, thus the effect of the intervention on physical activity levels is of interest. In addition, type 2 diabetes has been shown to detrimentally affect cognitive function. Therefore, the evaluation will also assess the effect of the community-based sport intervention on cognitive function in the type 2 diabetes patients.
This project will engage inactive patients diagnosed with type 2 Diabetes in regular sport and physical activity. The aim of the project is to use community based sport and physical activity to enhance health and wellbeing and to facilitate the effective management of type 2 diabetes. Working in Nottingham City with 60 GP Practices and their Diabetes Specific Nurses, and in the 3 south area CCGs with up to 60 GP Practices, patients' sporting interests and motivations will be identified and matched with appropriate, local, community-based sport and exercise opportunities delivered by specially trained instructors and coaches. The aim of the study (total duration 3 years) is to engage 4032 people in 1 x 30 minutes of sport/exercise per week, for 12 months.
Primary research question(s)/evaluation aim(s):
Change from baseline in number of participants reporting one or more sessions of sport per week measured by the UK Single Item Questionnaire.
Secondary research question(s)/evaluation aim(s):
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
- None
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetic
排除标准
- •taking part in regular sport or physical activity (more than 30 minutes on one day per week)
结局指标
主要结局
Change from baseline in number of participants reporting one or more sessions of sport per week measured by the UK Single Item Questionnaire
时间窗: 3 years
次要结局
- Change from baseline in waist circumference(3 years)
- Change from baseline in control of blood glucose concentration as measured by HPA1c (mmol/mol)(3 years)
- Change from baseline in quality of life as measured by the quality of life survey (QOLS)(sum of 16 item 7 point likert scale)(3 years)
- Change from baseline in body mass (kg)(3 years)
- Change from baseline in control of blood glucose concentration as measured by self-report survey (subjective rating, 'better', 'the same', 'worse'(3 years)
- Change from baseline in hip circumference (cm)(3 years)
研究者
Prof. Mary Nevill
Professor and Head of Department of Sport Science
Nottingham Trent University