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临床试验/CTRI/2025/02/081211
CTRI/2025/02/081211尚未招募不适用

An Experimental study for Assessment of effects of Short-term 6 degree Head-Down Tilt with/without superimposed Isometric handgrip on Cardiovascular Variabilities in Physically Active and Sedentary Young Adults

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年3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
102
试验地点
1
主要终点
Change in heart rate and blood pressure during 6 degree Head-down tilt.

研究概览

简要总结

This study is a non-randomized, parallel group experimental trial comparing the autonomic and cardiovascular responses between sedentary and physically active individuals during a 46-minute protocol. The primary objective is to assess heart rate variability (HRV), blood pressure variability (BPV), and baroreflex sensitivity (BRS) in both groups under different conditions: supine rest, 6-degree head-down tilt, isometric handgrip, and isometric handgrip superimposed with head-down tilt. The study will involve 102 participants, with 51 sedentary individuals and 51 physically active individuals. The secondary outcomes will include the comparison of HRV, BPV, and BRS between both groups under each experimental condition, as well as analysis of the interaction between isometric grip and head-down tilt in modifying autonomic and cardiovascular responses.

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
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Male

入选标准

  • Healthy individuals willing to participate in study.

排除标准

  • Systolic BP more than 140mmHg and Diastolic BP more than 90 mm Hg. Complaints of syncope.
  • Symptoms of Autonomic function disorder(Screening through questionnaire) Structural heart disease or any other CVS disorder (Myocardial infarction, Congestive Heart Failure).
  • Chronic illness (Diabetes Mellitus, Chronic kidney disease, Chronic liver disease) Major surgeries in past 6 months.
  • History of increased intraocular pressure/ocular surgery in past 6 months.
  • Intake of drugs that have effect on autonomic nervous system.
  • Professional athletes (vigorous exercise more than 1 hour in a day).

结局指标

主要结局

Change in heart rate and blood pressure during 6 degree Head-down tilt.

时间窗: At baseline

次要结局

  • Change in Heart Rate Variability (HRV), Blood Pressure Variability (BPV), & Baroreceptor Sensitivity (BRS) during a 6° Head-down Tilt.(Effect of isometric handgrip on HRV, BPV, & BRS during 6° HDT)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ashutosh Kashyap

AIIMS Rishikesh

研究点 (1)

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