Post Coronary Artery Bypass GraftingNCT06673953
Effect of Respiratory Trainer on Cardiopulmonary Functions in Patients with Upper Cross Syndrome Post-Cardiac Surgery
A study testing Respiratory Muscle Training by (The Breather) and Traditional physical therapy program in people with Post Coronary Artery Bypass Grafting and Post-Cardiac Surgery Patients, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, men only
- Conditions the study is for
- Post Coronary Artery Bypass Grafting, Post-Cardiac Surgery Patients, Upper Cross Syndrome
- What is being tested?
- Respiratory Muscle Training by (The Breather) and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2024to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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 3-7.
- Their body mass index ranges from (25 -29.9) kg/m2.
- Values of FEV1 and FVC lower than 80%
Who cannot join
- 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/m2.
- Smokers.
- Values of FEV1 and FVC higher than 80%
- Patients with chronic obstructive pulmonary disease or asthma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 11432
Faculty of Physical Therapy, Cairo University, 02 37617691, Info@pt.cu.edu.eg
About this study
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.
Read the detailed description
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:
- 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.
- Treatment equipment:
- Respiratory muscle trainer device (The Breather device).
- DCF muscles training device: Pressure biofeedback (Stabilizer TM, Chattanooga Group, Inc., Chattanooga, TN)
- Gymna electrotherapy device.
- EME ultrasound-therapy device.
- A 650-W infrared halogen lamp (Philips Electronics Industries)
Procedure:
- Evaluation Procedures: All patients will follow the same evaluative procedures before (baseline) and after 12 weeks of treatment. (illustrated in the Outcome Measures section)
- 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:
- TENS: Conventional TENS will be applied at high frequency (from 50 Hz to 130 Hz), low intensity (comfortable, not painful) and small pulse duration (50 μs to 200 μs). By applying small surface electrodes on the neck paraspinal muscles for 20 minutes.
- Low-intensity continuous ultrasonic waves will be applied on the neck paraspinal muscles (trigger points of the trapezius muscles) for 10 minutes.
- Infrared radiation application will be used for 10 minutes: The lamp should cover the area over the upper back and neck regions.
- Cervical Stabilization exercise will be performed after three repetitions of stretching exercises for neck muscles as warm-up and cool-down exercises. Then, the exercise will be executed in supine position; the cuff will be put suboccipital. They will reach a 5mm Hg pressure target with increments of 2 mm Hg from a baseline of 20mm Hg to the ultimate level of 30mm Hg with hold for 10 seconds. The duration of contraction will gradually increase up to 10 seconds for each target level. Subjects will perform ten repetitions before progressing to the next target level.
Traditional (control) group: Patients will receive the traditional physical therapy program.
- Conditions
- Post Coronary Artery Bypass Grafting, Post-Cardiac Surgery Patients, Upper Cross Syndrome, Respiratory Muscle Weakness, Respiratory Muscle Training
- Being tested
- Respiratory Muscle Training by (The Breather), Traditional physical therapy program
- Keywords
- Post-CABG / Upper Cross Syndrome / Respiratory Muscle Training
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle Training by (The Breather)Other
Also called Respiratory Muscle Training
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.
Traditional physical therapy programOther
Also called Conventional physical therapy program
Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise )
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Respiratory Muscle Training by (The Breather); Other: Traditional physical therapy program |
| 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. Receives: Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (%)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Baseline (assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start28 Aug 2024
- Primary completion20 Jan 2025 (estimated)
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa ali, Cairo University
- Investigators
- Zeinab Helmy, Professor, Study chair, Professor of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo UniversityEl-Sayed Felaya, Lecturer, Study director, Lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo UniversityAhmed Elsisi, Assistant Professor, Study director, Assistant Professor of Critical Care Medicine. Faculty of Medicine. Beni suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673953
- Sponsor's protocol ID
- P.T.REC/012/005197
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Trainer on Cardiopulmonary Functions in Patients with Upper Cross Syndrome Post-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06673953
- Acronym / sponsor ID
- P.T.REC/012/005197
- Conditions
- Post Coronary Artery Bypass Grafting, Post-Cardiac Surgery Patients, Upper Cross Syndrome, Respiratory Muscle Weakness, Respiratory Muscle Training
- Keywords
- Post-CABG / Upper Cross Syndrome / Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- Treatment equipment:
- Respiratory muscle trainer device (The Breather device).
- DCF muscles training device: Pressure biofeedback (Stabilizer TM, Chattanooga Group, Inc., Chattanooga, TN)
- Gymna electrotherapy device.
- EME ultrasound-therapy device.
- A 650-W infrared halogen lamp (Philips Electronics Industries)
Procedure:
- Evaluation Procedures: All patients will follow the same evaluative procedures before (baseline) and after 12 weeks of treatment. (illustrated in the Outcome Measures section)
- 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:
- TENS: Conventional TENS will be applied at high frequency (from 50 Hz to 130 Hz), low intensity (comfortable, not painful) and small pulse duration (50 μs to 200 μs). By applying small surface electrodes on the neck paraspinal muscles for 20 minutes.
- Low-intensity continuous ultrasonic waves will be applied on the neck paraspinal muscles (trigger points of the trapezius muscles) for 10 minutes.
- Infrared radiation application will be used for 10 minutes: The lamp should cover the area over the upper back and neck regions.
- Cervical Stabilization exercise will be performed after three repetitions of stretching exercises for neck muscles as warm-up and cool-down exercises. Then, the exercise will be executed in supine position; the cuff will be put suboccipital. They will reach a 5mm Hg pressure target with increments of 2 mm Hg from a baseline of 20mm Hg to the ultimate level of 30mm Hg with hold for 10 seconds. The duration of contraction will gradually increase up to 10 seconds for each target level. Subjects will perform ten repetitions before progressing to the next target level.
Traditional (control) group: Patients will receive the traditional physical therapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory training (study) group. | Experimental | Other: Respiratory Muscle Training by (The Breather), Other: Traditional physical therapy programThirty 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 | Other: Traditional physical therapy programThirty patients (n=30) receiving the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 3-7.
- Their body mass index ranges from (25 -29.9) kg/m2.
Key exclusion criteria (7 listed)
- 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/m2.
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Muscle Training by (The Breather)Also: Respiratory Muscle TrainingPatients 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. | Other | Respiratory training (study) group. |
| Traditional physical therapy programAlso: Conventional physical therapy programTraditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise ) | Other | Respiratory training (study) group., Traditional (control) group |
Primary outcome
Pulmonary functions:
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (assessment)
Weight and height are recorded, and BMI will be calculated according to the formula: BMI = Weight (Kg) / Height (m2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeinab Helmy, Professor study chair
Professor of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University
El-Sayed Felaya, Lecturer study director
Lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University
Ahmed Elsisi, Assistant Professor study director
Assistant Professor of Critical Care Medicine. Faculty of Medicine. Beni suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Training by (The Breather) and Traditional physical therapy program in people with Post Coronary Artery Bypass Grafting and Post-Cardiac Surgery Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Ali (+201004580951, mostafaaly.atia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary functions: (time frame: Baseline (assessment), and at 12 weeks post-intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.