Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time change in range
研究概览
简要总结
Patients with type 1 diabetes usually present cardiovascular risk factors. Sixty percent of them are overweight or obese, 40% have hypertension, 60% have dyslipidemia, leading to cardiovascular disease as the major cause of death in adults with type 1 diabetes. Regular exercise can help patients to improve cardiovascular disease risk profile, metabolic control and chronic complications. Recommendations for exercise in children with diabetes are the same as the general population, between ages 8 to 18 years 60 min of physical exercise/day is suggested, including moderate or vigorous aerobic activity (at least 20 minutes), muscle strengthening and bone strengthening activities. Children with type 1 diabetes have poorer physical fitness levels than the non-diabetic peers and it has been described some barriers to meet these recommendations between children and adolescents with type 1 diabetes such as the fear of hypoglycemia, external temperature, work schedule, loss of control of diabetes, a low fitness level. The two types of exercise (aerobic and anaerobic) are recommended in people with diabetes. High intensity interval training involves alternation between brief periods of vigorous exercise and recovery at low to moderate intensity. Has been shown that HIIT is associated with improving aerobic capacity without a detrimental decline in blood glucose in adults with type 1 diabetes and home-based high-intensity interval training reduces barriers to exercise in the same group. The objective of the present study is to propose a HIIT exercise protocol through online modality to a group of adolescents with type 1 diabetes to evaluate the metabolic effects and physical capacity through an analytical, prospective and longitudinal study (before and after) for 3 months. As primary outcome is expected to improve metabolic control shown as an increase in time in range on continuous glucose monitoring and a decrease in glycosylated hemoglobin. And as secondary results, improve the aerobic capacity and resistance strength, lipid profile parameters, anthropometric and on the mood of the participants.
详细描述
Hypothesis Three month HIIT training program increases time in range (TIR) and decreases glycemic variability (MAGE) in adolescents with DM1.
HIIT training program improves physical fitness (aerobic capacity and strength) of adolescents with DM1.
Methodology Analytical, prospective, longitudinal study (before and after). This type of study was chosen for ethical reasons. A group will not be left without intervention knowing the benefits of physical exercise in patients with DM1.
HIIT for 3 months
Population of study This study will be carried out with adolescents with type 1 diabetes treated at the sponsoring Hospitals: Las Higueras and Guillermo Grant Benavente.
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
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The eligibility criteria will be applied to the group of patients treated at Las Higueras Hospital and Guillermo Grant Benavente Hospital
- •Inclusion Criteria:
- •Adolescents with type 1 diabetes
- •Ages: 12-19 years (and in pubertal stage of at least Tanner stage III breast or genitalia)
- •HbA1c between 7 and 11.5%
- •Total daily insulin dose ≥0.7 units/kg/day.
- •Both genders
- •Patients treated regularly at Las Higueras Hospital and Guillermo Grant Benavente Hospital.
排除标准
- •< 1 year of diabetes
- •Any medical, mental or physical disability that contraindicates exercise.
- •Practice of regular, structured and planned physical exercise outside the project, more than 2 times a week.
- •Pregnancy or breastfeeding
- •> 1 episode of severe hypoglycemia in the last 6 months
- •Eligibility criteria:
- •If the patient meets the inclusion criteria and does not present exclusion criteria, he/she may proceed to carry out physical evaluations to determine if has the conditions to perform the intervention. The patient may be ineligible for investigation in case of:
- •Upon completing the Cafra test, His/her heart rate is> or equal to 160 (20, 23)
- •If he/she shows blood pressure compatible with arterial hypertension before or after the initial physical evaluation.
- •Definition of arterial hypertension according to the recommendations of the American Academy of Pediatrics (30):
- •Blood pressure> or equal to the 95th percentile or> 130/80 mm Hg in adolescents greater than or equal to 13 years.
- •If he/she develops any signs of post-exercise musculoskeletal injury (functional impotence, pain or swelling joint)
- •In case they present a score ≥11 in the PHQ-9 questionnaire without mental health evaluation.
结局指标
主要结局
Time change in range
时间窗: Three months after finishing training
Time in Range (TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180)
次要结局
- Change in heart rate(Three months after finishing training)
- Change in resistance strength(Three months after finishing training)
- Change in total insulin dose(Three months after finishing training)
- Change in hemoglobin A1c(Three months after finishing training)
- Change in triglycerides(Three months after finishing training)
- Changes in waist circumference(Three months after finishing training)
- Changes in aerobic capacity(Three months after finishing training)
- Changes in body composition(Three months after finishing training)
- Changes in systolic blood pressure(Three months after finishing training)
- Change in mood of adolescents(Three months after finishing training)
- Change in cholesterol(Three months after finishing training)
- Frequency of hypoglycemia episodes during the training(Three months after finishing training)
研究者
JULIO SOTO BARROS
Pediatric endocrinologist
Hospital Las Higueras