Effects Of A Multimodal Prehabilitation Program On Orthopedic Implant Surgery Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the effects of a multimodal prehabilitation program (psychological support, breathing exercises, and HRV monitoring) versus standard care on postoperative complications and functional recovery in orthopedic implant surgery patients
研究概览
简要总结
This randomized controlled trial will evaluate a multimodal prehabilitation program combining psychological counselling, slow breathing exercises, and heart rate variability (HRV) monitoring in patients undergoing orthopedic implant surgery. One hundred participants will be randomized into two groups: study (comprehensive prehabilitation plus standard care) and control (standard care alone). The intervention is delivered for one week prior to surgery.
Primary outcomes are postoperative complication rate and functional recovery. Secondary measures include stress (PSS-10), anxiety (HAM-A), quality of life (Flanagan QoL), pain scores, HRV indices, body composition, and biochemical markers (IL-6, IgG, MDA). Assessments are taken at admission, after the intervention, and one week post-surgery, with one-year telephonic follow-up for recovery and complications.
This study seeks to create a low-cost, structured prehabilitation protocol to optimize perioperative readiness and outcomes in orthopedic implant surgery patients.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for orthopedic implant surgery at SSSMCRI.
排除标准
- •Patients who are unwilling to participate.
结局指标
主要结局
To compare the effects of a multimodal prehabilitation program (psychological support, breathing exercises, and HRV monitoring) versus standard care on postoperative complications and functional recovery in orthopedic implant surgery patients
时间窗: At Baseline, 1 Week And 2 Weeks
次要结局
- To analyze the link of perceived stress score, Hamilton anxiety scale (HAM A)(rating, Flanagan quality of life (QoL) score, immunological parameter, visual)
研究者
Auroprakash Pal
Shri Sathya Sai Medical College and Research Institute