Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Weight and height scales: To measure body weight and height to calculate BMI.
Visual Analog Scale (VAS): To assess pain severity.
Pressure biofeedback instrument: To measure endurance of deep cervical flexors (DCF).
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).
Pittsburgh Sleep Quality Index. To measure sleep quality (Arabic version)
pulse oximetry. To measure HR, and SPO2 (Pulse Oximeter GRANZIA Model No: AS-304).
Sphygmomanometer: To measure ABP (Model Number: GT001-110/111 aneroid sphygmomanometer, Zhejiang, China)
Stopwatch. To measure six-minute walk test time.
Short Form 36 (SF-36) Health Survey Questionnaire: To measure quality of life.
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:
Respiratory muscles training: They will be asked to perform respiratory training through The Breather device beginning with the easiest setting. They will be 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.
Traditional physical therapy program in the form of:
Traditional (control) group: Patients will receive the traditional physical therapy program.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory training (study) group. | Experimental | Thirty patients (n=30) receiving respiratory muscles training and traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes. |
|
| Traditional (control) group | Active Comparator | Thirty patients (n=30) receiving the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Muscle Training by (The Breather) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 (%) | 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 | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Ali | Contact | +201004580951 | mostafaaly.atia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zeinab Helmy, Professor | Professor of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University | Study Chair |
| El-Sayed Felaya, Lecturer | Lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Recruiting | Giza | Giza Governorate | 11432 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Traditional physical therapy program | Other | Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise ) |
|
|
| 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 | 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). | 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. | 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) | Baseline (assessment) |
| Study Director |
| Ahmed Elsisi, Assistant Professor | Assistant Professor of Critical Care Medicine. Faculty of Medicine. Beni suef University | Study Director |
| ID | Term |
|---|---|
| C537866 | Oculocerebral hypopigmentation syndrome type Preus |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided