Effect of high intensity interval training versus moderate intensity continuous training on cardiac autonomic modulation in Type-2 Diabetes mellitus patients with cardiac autonomic neuropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
This prospective pre-test-post-test study will evaluate the effect of high intensity interval training versus moderate intensity continuous training on cardiac autonomic modulation in type 2 diabetes mellitus patients (35-55 years) with cardiac autonomic neuropathy. Fifty participant will be recruited and allocated into an two experimental group (HIIT and MICT) or control group. The HIIT group will perform supervised aerobic exercise three times per week for six weeks. The intensity of intervention will range from 85–95% HRmax and MICT group will perform supervised aerobic exercise three times per week for six weeks. The intensity of intervention will range from 60-70% HRmax. The control group will continue as usual activities. Baseline data including resting heart rate variability (HRV), heart rate recovery (HRR),glycemic control, lipid profile, body composition, sleep quality, functional capacity, and health related quality of life (HrQoL) will be collected one day before intervention and post intervention measurements will be taken one day after completion of 18 sessions of training using standardized protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 35-55 years Subjects with HbA1c greater than 6.5 percent Confirmed positive for Cardiovascular Autonomic Neuropathy (CAN) Duration of Type 2 Diabetes Mellitus (T2DM) between 1-10 years in the identified subjects Subjects with Pittsburgh Sleep Quality Index (PSQI) global score greater than 5 Patients using oral hypoglycemic agents only.
排除标准
- •Patients with any severe cardiovascular disease.
- •Patients with stage 2 hypertension Patients with any clinical orthopaedic problems that could limit his/her ability to participate in exercise training without inducing pain.
- •Patients involved in any structured exercise training from last 6 months will be excluded.
- •Patients who could not walk independently or have vision or hearing impairment will be excluded from the study.
结局指标
主要结局
Heart rate variability
时间窗: baseline and after 6 weeks intervention
• Heart rate recovery
时间窗: baseline and after 6 weeks intervention
• Glycemic control
时间窗: baseline and after 6 weeks intervention
次要结局
- Sleep quality(• Functional capacity)
研究者
AISHA MD AZIZ
Jamia Millia Islamia