跳至主要内容
临床试验/CTRI/2025/10/095841
CTRI/2025/10/095841尚未招募不适用

Enhancing Cognitive functionality in Elderly Population Undergoing Major Surgery under General Anaesthesia: A comparative study of Yoga and Physical Prehabilitation Methods

Dr. Puneet Khanna1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
1. To compare the effect of yoga-based prehabilitation and traditional physical prehabilitation in reducing the occurrence of POD in patients undergoing general major surgery.

研究概览

简要总结

Surgery is essential for treating various diseases but often leads to cognitive complications such as delirium and Postoperative Cognitive Dysfunction (POCD), particularly in older adults. These complications can negatively impact recovery, quality of life, and healthcare costs. While physical prehabilitation is widely recognized for improving surgical outcomes, the role of cognitive prehabilitation remains underexplored. This study compares the effectiveness of yoga-based prehabilitation and physical prehabilitation in enhancing cognitive function before surgery. It will assess key cognitive measures, including attention, processing speed, and memory, in elderly patients undergoing major surgery under general anesthesia.

A total of 200 patients aged 60ys and above will be recruited and randomized into two groups: Group A (Physical Prehabilitation) and Group B (Yoga). Group A will undergo supervised aerobic and resistance exercises, while Group B will participate in guided yoga sessions focusing on breathing techniques and relaxation. Both groups will follow Enhanced Recovery After Surgery (ERAS) guidelines, and cognitive function will be assessed using Depression, Anxiety, and Stress Scale (DASS-21) to evaluate mental states and the Montreal Cognitive Assessment (MoCA) to assess cognitive functions across six domains: memory, executive functioning, attention, language, visuospatial skills, and orientation. Additionally, blood biomarkers (BDNF, MDA, CRP, TNF-Alpha, Dopamine, and Noradrenaline) will be analyzed at multiple time points to evaluate physiological responses to each intervention.

By comparing these two approaches, this study aims to identify the most effective prehabilitation strategy for preserving cognitive health and improving surgical recovery in elderly patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients Age above 60 years.
  • Undergoing major surgery under General Anaesthesia
  • ASA I and ASA II.
  • Fried Frailty Index more than 1
  • There is no minimum cognitive performance required to participate
  • Can give informed consent.

排除标准

  • 未提供

结局指标

主要结局

1. To compare the effect of yoga-based prehabilitation and traditional physical prehabilitation in reducing the occurrence of POD in patients undergoing general major surgery.

时间窗: 1. Before Intervention | 2. 24 hours before surgery | 3. 24 hours after surgery | 4. 8 weeks after surgery

2. To evaluate and compare the impact of yoga-based prehabilitation and physical prehabilitation on the incidence and severity of POCD in patients undergoing general major surgery.

时间窗: 1. Before Intervention | 2. 24 hours before surgery | 3. 24 hours after surgery | 4. 8 weeks after surgery

次要结局

  • 1. To evaluate the association between specific biomarkers (BDNF, MDA, CRP, TNF-alpha, dopamine, and noradrenaline) and the incidence of POCD and POD in patients participating in yoga-based prehabilitation versus traditional physical prehabilitation.(1. Before Intervention)

研究者

发起方
Dr. Puneet Khanna
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Puneet Khanna

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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