Effect of Respiratory Trainer on Cardiopulmonary Functions in Patients with Upper Cross Syndrome Post-Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pulmonary functions:
研究概览
简要总结
The purpose of this study is to investigate if there is any effect of the respiratory training on cardiopulmonary functions in patients with upper cross syndrome post-cardiac surgery.
Hypothesis:
Null hypothesis: There is no effect of the respiratory training on pulmonary functions in patients with upper cross syndrome post-cardiac surgery.
详细描述
Sixty post-CABG-male-patients (n=60) with upper cross syndrome, their age ranges from 45 to 55 years old, are selected from Elbank-Elahly hospital (out-patient clinic), Cairo, Egypt. This randomized control study is performed after assessing and randomly assigning patients, (through using a computer program which generates random numbers), into two equal groups (30 patients for each group).
Respiratory training (study) group. Thirty patients (n=30) will receive respiratory muscles training and traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
Traditional (control) group. Thirty patients (n=30) will receive the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
All subjects enrolled in the study are informed about the aim, technique, and experimental protocol of this study before participation. A written informed consent is assigned before participation.
After open-heart surgeries, patients with median sternotomy must restrict upper limbs movements that stretch the sternum, for 8 to 12 weeks after surgery, and avoid raising their arms above the head.
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
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sixty post-CABG-male-patients for at least three months and their age ranges from 45 to 55 years old.
- •Craniovertebral angle < 51°, but not less than 30°.
- •Non-specific chronic neck pain: defined as neck pain without an identifiable pathological cause and attributed to poor posture without radiation to upper limbs.
- •VAS score between 3-
- •Their body mass index ranges from (25 -29.9) kg/m
- •Values of FEV1 and FVC lower than 80%
排除标准
- •Rheumatoid arthritis, cervical disc pathology, and traumatic neck pain.
- •History of respiratory disease and clinical signs of severe cardiac events.
- •Neurological disorders which affect the diaphragm.
- •Patients whose BMI is less than 25, or greater than 30 kg/m
- •Values of FEV1 and FVC higher than 80%
- •Patients with chronic obstructive pulmonary disease or asthma.
研究组 & 干预措施
Respiratory training (study) group.
Thirty patients (n=30) receiving respiratory muscles training and traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
干预措施: Respiratory Muscle Training by (The Breather) (Other)
Respiratory training (study) group.
Thirty patients (n=30) receiving respiratory muscles training and traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
干预措施: Traditional physical therapy program (Other)
Traditional (control) group
Thirty patients (n=30) receiving the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
干预措施: Traditional physical therapy program (Other)
结局指标
主要结局
Pulmonary functions:
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Measurements of ventilatory function are recorded before and after receiving the treatment sessions (FEV1, FVC, FEV1/FVC, MVV). Assessing respiratory improvement. Unit of Measure: Liters (L)
Six-Minute-Walk Test
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Patients are asked to walk for 6 minutes along a flat corridor. Measured in meters, assessing exercise capacity and functional improvement. The SpO2 and heart rate are measured continuously during testing. Heart Rate (HR): Measured in beats per minute (BPM), evaluating cardiovascular response. SpO2 (Peripheral Oxygen Saturation): Assessing: Blood oxygen saturation levels to evaluate respiratory and cardiovascular efficiency. Unit of Measure: Percentage (%)
VO2 max (Maximal Oxygen Consumption)
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Assessing: Maximum oxygen uptake during high-intensity exercise to evaluate aerobic capacity and cardiopulmonary function. Estimated based on an equation which contains: weight is body weight (kg), 6MWD is distance walked in 6 min (m), age (years), BMI is calculated body mass index(kg/m2), height is body height (cm) and HR is heart rate at the end of the walking test. Unit of Measure: mL/kg/min
Pittsburgh Sleep Quality Index.
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Respondents are asked to indicate how frequently they have experienced certain sleep difficulties and rate them. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Short Form 36 (SF-36) Health Survey Questionnaire (Arabic version).
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
A 36-item scale measures eight domains of health status. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Pain severity
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Assessing intensity of perceived pain for monitoring changes in pain severity throughout the intervention. Pain severity is assessed by the self-reported Visual Analog Scale (VAS). By using a 10 cm line where patients mark their pain level, with 0 representing "no pain" and 10 representing "worst imaginable pain." Unit of Measure: Points on a 0-10 scale
Endurance of DCF
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Endurance of DCF muscles is measured by a pressure biofeedback instrument. The patient lays in the crook lying position and the pressure biofeedback instrument is placed under the neutral cervical spine below the occiput and inflated up to 20 mmHg. The subjects perform this movement at 5 different pressure levels, i.e., 22, 24, 26, 28, and 30 mmHg. Each level is supposed to be held for 10 sec, and the test terminated if they are unable to hold the position for 10 sec at any level or if the maximum level is achieved (30 mmHg).
Craniovertebral angle measurement
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Adhesive markers are placed on the tragus of the right ear and the C7 spinous process, and the subjects are instructed to stand by side (lateral view) and to look at a target in front of them with both arms beside the body. Then, a digital camera is fixed at the level of the 7th cervical vertebra. Finally, the Surgi map Spine software is used to analyze the digitalized photographs and measure CVA. It is the angle between 2 imaginary lines: the horizontal line passing through the spinous process of C7 and the line passing from C7 to the tragus of the ear.
Weight and height measurement
时间窗: Baseline (assessment)
Weight and height are recorded, and BMI will be calculated according to the formula: BMI = Weight (Kg) / Height (m2)
次要结局
未报告次要终点
研究者
Mostafa ali
Assistant Lecturer
Cairo University