Effect of Respiratory Trainer on Cardiopulmonary Functions in Patients with Upper Cross Syndrome Post-Cardiac Surgery

NCT ID: NCT06673953

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2025-02-25

Brief 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.

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:

A. Evaluative equipment:

1. Weight and height scales: To measure body weight and height to calculate BMI.

2. Visual Analog Scale (VAS): To assess pain severity.

3. Pressure biofeedback instrument: To measure endurance of deep cervical flexors (DCF).

4. 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).

5. Pittsburgh Sleep Quality Index. To measure sleep quality (Arabic version)

6. pulse oximetry. To measure HR, and SPO2 (Pulse Oximeter GRANZIA Model No: AS-304).

7. Sphygmomanometer: To measure ABP (Model Number: GT001-110/111 aneroid sphygmomanometer, Zhejiang, China)

8. Stopwatch. To measure six-minute walk test time.

9. Short Form 36 (SF-36) Health Survey Questionnaire: To measure quality of life.

B. Treatment equipment:

1. Respiratory muscle trainer device (The Breather device).

2. DCF muscles training device: Pressure biofeedback (Stabilizer TM, Chattanooga Group, Inc., Chattanooga, TN)

3. Gymna electrotherapy device.

4. EME ultrasound-therapy device.

5. A 650-W infrared halogen lamp (Philips Electronics Industries)

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:

1. 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.

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Respiratory Muscle Training by (The Breather)

Intervention Type: 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.

Traditional physical therapy program

Intervention Type: OTHER

Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise )

Traditional (control) group

Thirty patients (n=30) receiving the traditional physical therapy program for six weeks (three sessions/ week) for 40-60 minutes.

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy program

Intervention Type: OTHER

Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise )

Interventions

Respiratory Muscle Training by (The Breather)

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.

Intervention Type: OTHER

Traditional physical therapy program

Traditional physical therapy program in form of: (TENS / Low-intensity continuous ultrasonic / Infrared radiation application / Cervical Stabilization exercise )

Intervention Type: OTHER

Other Intervention Names

Respiratory Muscle Training; Conventional physical therapy program

Eligibility Criteria

Inclusion Criteria

• 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%

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa ali

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeinab Helmy, Professor

Role: STUDY_CHAIR

Professor of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University

El-Sayed Felaya, Lecturer

Role: STUDY_DIRECTOR

Lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics. Faculty of Physical Therapy. Cairo University

Ahmed Elsisi, Assistant Professor

Role: STUDY_DIRECTOR

Assistant Professor of Critical Care Medicine. Faculty of Medicine. Beni suef University

Locations

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa Ali

Role: CONTACT

mostafaaly.atia@gmail.com

+201004580951

Facility Contacts

Faculty of Physical Therapy, Cairo University

Role: primary

Info@pt.cu.edu.eg

02 37617691

Other Identifiers

P.T.REC/012/005197

Identifier Type: -

Identifier Source: org_study_id