Effect of Physiotherapeutic Clavipectoral and Sternoclavicular Fascia Release on Cardiopulmonary Parameters Post Cardiac valve replacement Surgery A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Respiratory Rate in breaths/min,
研究概览
简要总结
The study titled "Effect of Physiotherapeutic Clavipectoral and Sternoclavicular Fascia Release on Cardiopulmonary Parameters in Post Cardiac Valve Replacement Surgery: A Randomized Clinical Trial" will be conducted to assess the impact of fascial release techniques on cardiopulmonary and other functional outcomes in patients undergoing cardiac valve replacement surgery. Subjects will be selected based on defined inclusion and exclusion criteria. Patients aged between 40 to 80 years, of either sex, who will undergo uncomplicated elective cardiac surgery and are medically stable, will be included. Those with unstable angina, uncontrolled heart rhythm abnormalities, serious coexisting illnesses, or a prior history of cardiac or lung disease will be excluded. All participants will provide informed consent after receiving a detailed explanation of the procedure.
A total of 64 patients will initially be assessed, with some expected to be excluded or refuse participation. The remaining subjects will be randomly allocated into two groups. Group A will receive conventional cardiac rehabilitation, while Group B will receive additional physiotherapeutic intervention involving clavipectoral and sternoclavicular fascial release. The study will follow a randomized controlled trial design, and subjects will be selected using convenience sampling followed by random allocation. Data will be collected at three different time points: preoperatively on day zero, and postoperatively on day five and day ten. Variables to be measured will include respiratory parameters such as respiratory rate, oxygen saturation, chest expansion at various thoracic levels, and peak expiratory flow rate; cardiac functions like heart rate and blood pressure; and other outcomes such as craniovertebral angle, balance, functional capacity, pain, and psychological parameters including depression, anxiety, and stress. The study will be carried out over a four-month period at a reputed hospital in Delhi and aims to determine whether fascial release techniques provide additional benefits over standard rehabilitation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •patients aged 40–65 years, medically stable and referred by a cardiac surgeon, of either sex (male or female), undergoing elective surgical cases for cardiac rehabilitation with stable vitals, uncomplicated cases of surgery referred by a cardiothoracic surgeon, classified as NYHA class 1 to 3, with LVEF greater than 30%, and subjects who understand the Hindi language and are willing to participate.
排除标准
- •Unstable angina pectoris, uncontrolled arrhythmias, intermittent mandatory ventilation (IMV) on or after the 0th day, any life-threatening co-morbidities, any locomotor, neurological, or systemic disorder, use of medications apart from valve replacement surgical treatment that can affect the outcome of the study, and a history of prior cardiac surgery, stroke, or pulmonary diseases that can affect the outcome of the study.
结局指标
主要结局
Respiratory Rate in breaths/min,
时间窗: Baseline (before intervention) preoperatively | Post operatively on 5th day | Post operatively on 10th day
SPO2 (oxygen saturation) in %,
时间窗: Baseline (before intervention) preoperatively | Post operatively on 5th day | Post operatively on 10th day
Chest expansion in centimeters,
时间窗: Baseline (before intervention) preoperatively | Post operatively on 5th day | Post operatively on 10th day
Heart rate in beats/min,
时间窗: Baseline (before intervention) preoperatively | Post operatively on 5th day | Post operatively on 10th day
Blood pressure in mm hg.
时间窗: Baseline (before intervention) preoperatively | Post operatively on 5th day | Post operatively on 10th day
次要结局
- CVA (Craniovertebral angle) in degrees(Balance score by berg balance scale)
研究者
Aishwarya Aishwarya
Delhi Pharmaceutical Sciences and Research University
