跳至主要内容
临床试验/CTRI/2024/06/068372
CTRI/2024/06/068372招募中Phase 3 4

Integrated Yoga-Based Cardiac Rehabilitation Program in Myocardial Infarction

Shreyansh Chauhan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月16日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
1. Effects of Yoga-Care Rehabilitation program on Cardiac Profile -LVEF, BNP, and 6-MWT in MI patients

研究概览

简要总结

This study, conducted at Sir Sunderlal Hospital, Banaras Hindu University, Varanasi, aims to assess the efficacy of an Integrated Yoga-Based Cardiac Rehabilitation Program for patients recovering from Myocardial Infarction (MI). Patients will be randomly assigned to two groups: a study group receiving Integrated Yogic approach with standard pharmacotherapy, and a control group receiving exercise-based standard medical care. The study will evaluate the program’s effects on cardiac profile parameters such as LVEF, BNP, and 6-MWT, as well as its impact on inflammatory markers IL-6 and hsCRP, and overall quality of life. The duration of the main protocol, from screening to last follow-up, is estimated to be 12 months. Initial study will involve 10 randomized patients in each arm, with the main study to be conducted with total 60 patients in both the groups. Inclusion criteria include patients above 18 years of age experiencing first-time MI, while exclusion criteria involve severe musculoskeletal diseases and other associated physiological conditions. Statistical analysis will include assessment of cardiac performance using LVEF, BNP, and 6-minute walking test, as well as evaluation of mental, social, and emotional health using inflammatory markers IL-6 and WHO-QoL

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 Male and female patients aged above 18 years.
  • 3 Consent and compliance with all aspects of the study, protocol, and methods, providing data during follow-up contact.

排除标准

  • 1 Patients who have undergone Coronary artery bypass graft will not be included.
  • 2 The patient encountered recurrent Myocardial Infarction in his life will not be considered.
  • 3 Reporting history of concurrent pulmonary diseases like chronic obstructive pulmonary disease and severe musculoskeletal diseases like osteoarthritis restraining the patient from performing yoga.
  • 4 Patients with valvular heart disease for whom practicing yoga will not be easy.
  • 5 Cognitive or severe psychopathology that could prevent participation.
  • Involvement with any other ongoing studies.

结局指标

主要结局

1. Effects of Yoga-Care Rehabilitation program on Cardiac Profile -LVEF, BNP, and 6-MWT in MI patients

时间窗: Three Months

次要结局

  • 1. To assess the potential of yoga in improving serum inflammation markers and enhancing overall quality of life.(2. Effectiveness of physiotherapeutic intervention in MI and comparative analysis with yoga therapy.)

研究者

发起方
Shreyansh Chauhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreyansh Chauhan

Banaras Hindu University

研究点 (1)

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