Handball-based Exercise for People Diagnosed With Type 2 Diabetes: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)
研究概览
简要总结
This single-arm pilot study aims to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes, including monitoring aerobic intensities and movement strategies during the intervention, and monitoring recruitment, adherence, and adverse events.
Furthermore, the study aims to investigate the feasibility of a test battery including both physiological and patient-reported outcomes, and to investigate preliminary exercise effects.
详细描述
Physical activity and exercise are known to be beneficial for increasing insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes. But many patients who recently have been diagnosed with type-2 diabetes is often living a sedentary lifestyle and have poor adherence to physical interventions.
High intensity interval training as well as team-based interventions has proven to be effectful in regulation of physiological parameters related to type 2 diabetes. The aim of this study is to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 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
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes
- •Understands and speaks danish
排除标准
- •If General Practitioner do not recommend participation in the intervention
结局指标
主要结局
Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)
时间窗: change from baseline to 12 weeks
HbA1c measured with HemoCue HbA1c 501
Peak oxygen uptake (VO2peak)
时间窗: change from baseline to 12 weeks
Peak oxygen uptake measured with incremental cycling test
Health related quality of life (HRQoL)
时间窗: change from baseline to 12 weeks
Health related quality of life measured with the danish version of Short Form 36 (SF-36)
次要结局
- Physical activity levels(change from baseline to 12 weeks)
- Body fat mass (kg)(change from baseline to 12 weeks)
- Lean body mass (kg)(change from baseline to 12 weeks)
- Blood pressure and resting puls(change from baseline to 12 weeks)
- Body mass index (BMI)(change from baseline to 12 weeks)
- Aerobic intensity and movement patterns(measured during intervention in week 2,3,6,7,10 and 11.)
- Visceral fat (hip/waist ratio)(change from baseline to 12 weeks)
- Concentration of Cholesterol(change from baseline to 12 weeks)
- Aerobic performance test (aerobic endurance)(change from baseline to 12 weeks)
- Self-care behavior(change from baseline to 12 weeks)