An interventional study of Respiratory Muscle Training by (The Breather) and Traditional physical therapy program in Post Coronary Artery Bypass Grafting, Post-Cardiac Surgery Patients and Upper Cross Syndrome, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to male participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
In addition, inappropriate posture such as forward head posture caused by the incision leads to upper cross syndrome. This causes an inability to perform activities of daily living, and chronic neck pain which adversely affects the respiratory system due to respiratory muscle imbalance.
Chronic neck pain (CNP), due to upper cross syndrome, is one of the most prevalent and costly musculoskeletal complaints associated with significant functional disability.
Equipment:
A. Evaluative equipment:
Electronic Spirometer: Digital-CONTEC-SP10-Spirometer-Lung-Breathing-Diagnostic-Vitalograph-Spirometry-Model CMS501 (Made in China), to measure ventilatory function test parameters.
Forced expiratory volume in the first second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio. and Peak expiratory flow rate (PEFR).
B. Treatment equipment:
Procedure:
A. Evaluation Procedures: All patients will follow the same evaluative procedures before (baseline) and after 12 weeks of treatment. (illustrated in the Outcome Measures section)
B. Therapeutic procedures:
Respiratory training (study) group: Patients will receive:
Traditional physical therapy program in the form of:
Traditional (control) group: Patients will receive the traditional physical therapy program.
37 studies on the registry are indexed under Oculocerebral hypopigmentation syndrome type Preus; 20 are open to participants now.
This study's planned enrollment of 60 is above the median of 48 across 34 interventional studies indexed under Oculocerebral hypopigmentation syndrome type Preus.
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Exclusion Criteria:
Thirty patients (n=30) receiving respiratory muscles training and traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
Other: Respiratory Muscle Training by (The Breather) · Other: Traditional physical therapy program
Thirty patients (n=30) receiving the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.
Other: Traditional physical therapy program
Patients are instructed to inhale deeply and forcefully (at non fatigable resistance) for 2-3 seconds, slight pause, and then exhale forcefully for 2-3 seconds for 10 repetitions with 2 sets.
Also known as: Respiratory Muscle Training
Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise )
Also known as: Conventional physical therapy program
Pulmonary functions:
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)
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Six-Minute-Walk Test
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 (%)
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
VO2 max (Maximal Oxygen Consumption)
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
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Pittsburgh Sleep Quality Index.
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.
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Short Form 36 (SF-36) Health Survey Questionnaire (Arabic version).
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.
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Pain severity
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
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Endurance of DCF
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).
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Craniovertebral angle measurement
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.
Time frame: Baseline (assessment), and at 12 weeks post-intervention.
Weight and height measurement
Weight and height are recorded, and BMI will be calculated according to the formula: BMI = Weight (Kg) / Height (m2)
Time frame: Baseline (assessment)
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