Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Exercise intensity - objective internal load
研究概览
简要总结
Our main challenge is to develop a novel physical activity intervention to promote exercise participation sustainability and effective health benefits in type 2 diabetes (T2D) population with minimum health risks. The relevance of this study is supported by four cornerstones: 1) The Portuguese love football and there seems to be a major potential in the implementation of football practice as part of the prevention and treatment of noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies have assessed the feasibility and safety of a walking football exercise program for middle-age and older patients with T2D; 3) the proposed investigation relies on robust methodology; 4) this intervention can have further sustainability with the enrollment of football clubs and primary health care units.
详细描述
This work will be a quasi-experimental study where we aim to test the feasibility and safety of walking football in patients with T2D. The recruitment of participants will be held in primary health care units by Family Medicine medical doctors. All participants will receive instructions to maintain daily-life routines (lifestyle-related physical activity and dietary pattern), and to continue with usual care (diabetes consultations on primary health care units and pharmacological regimen) along the studies duration. All participants will receive basic sports material (sports bag, T-shirt, and sports shoes). Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety (acute effects on capillary glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Cumulative short-term effects will also be analyzed along the three months through pre- and post-study evaluations. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
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
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 2 diabetes for at least 12 months;
- •glycated hemoglobin bellow 10 %;
- •not having started insulin therapy in the previous six months;
- •not having started therapy with sulfonylureas in the previous six months;
- •major complications of diabetes screened and controlled (diabetic retinopathy, diabetic nephropathy and diabetic foot);
- •no symptoms of coronary artery disease;
- •no cardiovascular, respiratory and musculoskeletal contraindications to exercise;
- •not under cancer treatment (radiotherapy or intravenous chemotherapy);
- •without limitations in gait or balance;
- •independent living in the community;
- •not engaged in supervised exercise;
- •non-smokers at least for 6 months.
排除标准
- •cardiological stress test with cardiac or hemodynamic problems
研究组 & 干预措施
Exercise
Walking football exercise program
干预措施: Walking football exercise program (Behavioral)
结局指标
主要结局
Exercise intensity - objective internal load
时间窗: Through 3 months
Heart rate during exercise
Exercise intensity - external load
时间窗: Through 3 months
Distance (km) assessed using GPS tracking during exercise
Incidence of falls
时间窗: Through 3 months
Number of falls during the exercise program
Incidence of musculoskeletal injuries
时间窗: Through 3 months
Number of reported musculoskeletal injuries during the exercise program
Exercise intensity - subjective internal load
时间窗: Through 3 months
OMNI rating of perceived exertion scale during exercise (0 \[lowest\] to 10 \[highest\] points)
Acute glycemic effect
时间窗: Change between before and immediately after each exercise session
Acute change in capillary blood glucose with exercise sessions
Acute systolic blood pressure effect
时间窗: Change between before and immediately after each exercise session
Acute change in systolic blood pressure with exercise sessions
Acute diastolic blood pressure effect
时间窗: Change between before and immediately after each exercise session
Acute change in diastolic blood pressure with exercise sessions
Incidence of foot injuries
时间窗: Through 3 months
Number of reported foot injuries during the exercise program
Rate of Enjoyment
时间窗: Through 3 months
Self-reported exercise sessions' enjoyment on a likert scale (1 \[lowest\] to 5 \[highest\] points)
次要结局
- Clinical systolic blood pressure(Change from baseline to 3 months)
- Food pattern(Change from baseline to 3 months)
- Medication(Change from baseline to 3 months)
- Glycemic control(Change from baseline to 3 months)
- Blood lipid profile(Change from baseline to 3 months)
- Clinical diastolic blood pressure(Change from baseline to 3 months)
- Body mass index(Change from baseline to 3 months)
- Waist circumference(Change from baseline to 3 months)
- Body fat(Change from baseline to 3 months)
- Body lean mass(Change from baseline to 3 months)
- Agility/balance(Change from baseline to 3 months)
- Habitual physical activity(Change from baseline to 3 months)
- Health-related quality of life(Change from baseline to 3 months)
- Cognitive state(Change from baseline to 3 months)
研究者
Romeu Mendes
Researcher
Universidade do Porto