Effectiveness of Concurrent Resistance and Aerobic Exercise on Glycaemic Control and Quality of Life in Juvenile Diabetes Children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
Juvenile diabetes is a chronic metabolic disorder characterized by high plasma levels of glucose resulting from defect in insulin secretion, insulin action, or both. In juvenile DM autoantibodies of oneself attack Beta cells of pancreas which inhibits the synthesis of insulin from pancreas. Type 1 / Juvenile DM is a insulin dependent DM where there is absolute or no insulin production caused by autoimmune beta cell destruction in the pancreas. It usually occurs in children or adolescents therefore it is named as Juvenile DM When the glycemia is not under control children experience severe complication like Diabetic ketoacidosis, diabetic neuropathy, nephropathy, retinopathy, heart and blood vessel diseases.
Exercise has a direct positive effect on glycaemic control by promoting insulin secretion from beta pancreatic cells and by increasing skeletal muscle glucose uptake. Exercise promotes glucose uptake both acutely and overtime through the contraction mediated and insulin stimulated pathways therefore moderate to vigorous daily exercises can improve blood glucose management in patients with Juvenile DM Many families do not follow the recommendations that children and adolescents should spend in 60min or more of physical activity daily. Majority of young adults do not achieve physical fitness goals, especially in juvenile diabetes children there are many contributing factors like maintaining stable blood glucose levels before during and after exercise and also the fear of hypoglycaemia, therapist can play an important role in assisting families with these challenges as physical activity benefits with managing diabetes by improving glycaemic control, general health management and psychological well being.
Previous clinical trials have been conducted which provide evidence regarding the effectiveness of concurrent training for duration ranging from 12 weeks up to 32 weeks and these studies did not encourage overall body training. As there are no supporting studies which have intervened exercise prescription for children with juvenile diabetes in Karnataka and India, hence the purpose of the study arises to study the effectiveness of concurrent resistance and aerobics training using Peds QL Diabetes Module for a period of 8 weeks in children aged between 8 to 16 years with Juvenile diabetes while monitoring their glucose throughout the intervention under the supervision of a registered medical practitioner and to see the improvement in quality of life of juvenile diabetic population. This study can encourage physical activity in children with T1DM and improve the quality of living with the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Confirmed Juvenile diabetes mellitus in paediatric population Patients falling in the age group of 8 years to 16 years of either gender Duration of diabetes for at least one year or over Glycated haemoglobin (HbA1c) more than 7 percentile Patients on insulin therapy (on Multiple dose injections Basal Bolus regimen) Patients willing to participate.
排除标准
- •Non-willing parent not given consent Patients with cardiovascular risk uncontrolled diabetes Severe hypoglycaemia Other systemic disorders like Cushings disease and on steroid usage Diabetic Retinopathy Neuropathy Nephropathy Morbid obesity.
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: At baseline and after 8 weeks of intervention
Fasting blood sugar
时间窗: At baseline and after 8 weeks of intervention
Post prandial blood sugar
时间窗: At baseline and after 8 weeks of intervention
Random blood sugar
时间窗: At baseline and after 8 weeks of intervention
Daily total insulin dose
时间窗: At baseline and after 8 weeks of intervention
Number of hypoglycaemic events
时间窗: At baseline and after 8 weeks of intervention
次要结局
- Peds QL (Diabetes Module) scale(Peds QL (Generic core) scale)
研究者
Lavanya D
SDM COLLEGE OF PHYSIOTHERAPY
