Effect of Supra-abdominal Versus Infra-abdominal Muscles Training Combined With LASER on Sternal Instability After Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- sternal instability
研究概览
简要总结
the aim of this study is to find out the differences between the effect of supra- abdomen exercises and the effect of infra-abdomen exercise combined with LASER And the effect of LOW LEVEL LASER only on sternal instability. Methods: 120 patients of both sexes who had acute sternal instability post-open heart surgery will be recruited in this study at Assiout University Hospitals; their ages will be > 18 years. They will be randomly assigned into 4 equal groups:
- Study group (A): patients will receive supra-abdominal resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
- Study group (B): patients will do infra-abdominal resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
- Study group (c): patients will receive a traditional cardiac rehabilitation pro-gram of phase one with LLL
- Control group: patients will receive the traditional cardiac rehabilitation pro-gram of phase one only
详细描述
Type of study: Randomized controlled trial This study is a prospective interventional study one that will be conducted on 120 patients of both sexes who had acute sternal instability post-open heart surgery; their ages will be < 18 years. They will be recruited from Assiut University Hospitals and will randomly be divided into 4 equal groups
- Study group (A): patients will receive supra-abdomen resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
- Study group (B): patients will do infra-abdomen resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
- Study group (c): patients will receive a traditional cardiac rehabilitation pro-gram of phase one with LLL
- Control group: patients will receive Traditional cardiac rehabilitation pro-gram of phase one only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IInclusion criteria :
- •All included patients will be:
- •Their age 18<.
- •Both sexes.
- •Hemodynamic stable.
- •Acute sternal instability.
- •Able to provide informed consent.
排除标准
- •Patient will be excluded if:
- •Emergency or urgent operation.
- •Revision sternotomy.
- •Manifesting hypoxemia.
- •Partial oxygen pressure in arterial blood < 60 mmHg.
- •Renal insufficiency with serum creatinine ≥
- •8 mg/dl after surgery.
- •Low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads.
- •Cardiac arrhythmias or hypotension.
- •Other medical conditions, such as diabetes, uncontrolled hypertension and obesity.
- •Previous medical history including conditions that may have influenced the provision of physiotherapy interventions, such as severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse.
- •Impaired cognition.
研究组 & 干预措施
Group A: Supra-abdominal + LLL
Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I
干预措施: supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one (Behavioral)
Group A: Supra-abdominal + LLL
Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I
干预措施: patients will receive Traditional cardiac rehabilitation program of phase one only (Other)
Group B: Infra-abdominal + LLL
Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I.
干预措施: ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one. (Behavioral)
Group B: Infra-abdominal + LLL
Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I.
干预措施: patients will receive Traditional cardiac rehabilitation program of phase one only (Other)
Group C: LLL Only
Participants in this group receive low-level laser therapy in addition to the standard cardiac rehabilitation program during phase I.
干预措施: patients will receive Traditional cardiac rehabilitation program of phase one only (Other)
Group D: Control
Participants in this group receive the standard cardiac rehabilitation program during phase I.
干预措施: patients will receive Traditional cardiac rehabilitation program of phase one with LLL (Behavioral)
Group D: Control
Participants in this group receive the standard cardiac rehabilitation program during phase I.
干预措施: patients will receive Traditional cardiac rehabilitation program of phase one only (Other)
结局指标
主要结局
sternal instability
时间窗: at baseline and after finishing program (up to one month)
1. Sternal separation measurement: The ultrasound unit head was adapted by fixing it to a microphone stand to facilitate contact with the chest of a seated subject. The amount of sternal separation at different vertical points on the sternum could now be measured from the projected image using the proprietary software for the unit 2. Sternal instability scale: * Grade 0: * Clinically stable sternum, no detectable motion (normal). * Grade 1: * Minimally separated sternum with a slight increase in motion upon special testing (upper limbs, trunk). * Grade 2: * Partially separated sternum, regional with moderate increase in motion upon special testing. * Grade 3: * Completely separated sternum along the entire length with marked increase in motion upon special testing.
次要结局
- Functional Impairment Scale:(at baseline and after finishing program (up to one month))
- pain assessment(at baseline and after finishing program (up to one month))
- The Activity Status Index for Duke(at baseline and after finishing program (up to one month))
研究者
Mayar Mohammed Khalifa Ahmed
Physiotherapist
Beni-Suef University