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临床试验/CTRI/2024/10/075984
CTRI/2024/10/075984尚未招募不适用

Effect of moderate versus high intensity resistance training on cardiac autonomic modulation in type 2 diabetes mellitus patients with cardiac autonomic neuropathy: A randomised controlled trial

Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
43
试验地点
1
主要终点
Cardiac autonomic function

研究概览

简要总结

This study determine the effect of Moderate intensity resistance training (MIRT) versus High intensity resistance training (HIRT) on cardiac autonomic function and recovery as a primary outcome measure and glycemic control, muscle activity, and Health related quality of life as a secondary outcome measure in T2DM patients with Cardiac autonomic neuropathy (CAN). Fourty-three  type 2 diabetes patients with cardiac autonomic neuropathy will be randomly assigned to Moderate-intensity resistance training (MIRT, n=14), High-intensity resistance training (HIRT, n=14) and Control group (CG, n=15). Both the MIRT and HIRT groups will complete moderate-intensity resistance training and high-intensity resistance training 3 times/week for 6 weeks respectively. However, subjects in CG group will recieve only normal day-to-day activities for 6 weeks. Heart rate variability (HRV), heart rate recovery (HRR) and glycemic control (GC), muscle activity, and health related quality of life (HRQoL) will be assessed at baseline and at post intervention. This study provides understanding of cardiac autonomic response changes after MIRT vs. HIRT in T2DM patients with CAN, helping optimize exercise prescriptions.

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
45.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • a)Subjects with Hba1c (greater than 6.5%) b)Type 2 Diabetics positive for cardiac autonomic neuropathy b)Duration of Type 2 diabetes more than 1 year c)Patients using oral hypoglycemic agents only.

排除标准

  • a)Patients with any severe cardiovascular disease.
  • b)Patients with morbid obesity greater than 40 kg/m2 c)Patients with uncontrolled hypertension d)Patients with any clinical orthopedic problems that could limit his/her ability to participate in exercise training without inducing pain.
  • e)Patients involved in any structured exercise training from last 6 months will be excluded.
  • f)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

Cardiac autonomic function

时间窗: Baseline and after completion of 6 weeks of intervention

次要结局

  • 1. Glycemic control(2. Muscle activity)

研究者

申办方类型
Other [Central University]
责任方
Principal Investigator
主要研究者

Dr Shahid Raza

Jamia Millia Islamia

研究点 (1)

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