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临床试验/CTRI/2023/11/060077
CTRI/2023/11/060077尚未招募4 期

Effect of exercise training on cardiac autonomic function and left ventricular mass index in type 2 diabetes mellitus with cardiac autonomic neuropathy

Human Resource Development Group- Council of Scientific Research1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Cardiac autonomic function and left ventricular mass index

研究概览

简要总结

The study is randomized controlled trial in individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy, between ages 40 to 65 years of any gender. Participants with type 2 diabetes mellitus will be screened for cardiac autonomic neuropathy (CAN) using Cardiac Autonomic Reflex Tests (Ewing’s battery of 5 tests). Participants falling in the inclusion will be informed about the study and written informed consent will be taken. Baseline assessments of cardiac autonomic function (using cardiac autonomic reflex tests) left ventricular mass index (2D Echocardiography), heart rate variability, glycemic parameters, functional capacity (6-minute walk test) and quality of life (WHO QOL-BREF Questionnaire).  Participants will be randomized into intervention group (Standard care, routine physical activity education, exercise training) and control group (Standard care and routine physical activity education). The intervention will be for the duration of 12 weeks- consisting of aerobic, resistance and flexibility exercises. First 2 weeks of intervention will be supervised followed by a virtually supervised exercise program (using a validated digital application). After 12 weeks, cardiac autonomic function, heart rate variability, functional capacity and quality of life will be assessed in all participants. At 24th week (maintenance phase), all outcomes assessed at baseline will be reassessed in all participants.

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
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy.

排除标准

  • Type 1 diabetes mellitus, gestational diabetes mellitus and other genetic forms.
  • Presence of underlying conditions- Rheumatic heart disease, recent myocardial infarction, coronary artery bypass graft, heart failure, abdominal surgery in past 3 months, end stage renal disease, acute kidney injury, diabetic foot ulcers, severe systemic disease, any systemic neuromuscular disorder, any orthopedic surgery in past 6 months or injury limiting participation in exercise.

结局指标

主要结局

Cardiac autonomic function and left ventricular mass index

时间窗: Cardiac autonomic function at 3 time points- baseline, 12th week and 24th week | left ventricular mass index at 2 time points- baseline and 24th week

次要结局

  • Heart rate variability, glycemic parameters, functional capacity, quality of life(Heart rate variability, functional capacity, quality of life at 3 timepoints- baseline, 12th week and 24th week)

研究者

发起方
Human Resource Development Group- Council of Scientific Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Sohini Shailesh Raje

Manipal Academy of Higher Education

研究点 (1)

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