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

NCT06673953 | Recruiting

• 1 other identifier: P.T.REC/012/005197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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 Arms (2)

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.

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.

Other: Traditional physical therapy program

Interventions

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.

Also known as: Respiratory Muscle Training

Respiratory training (study) group.

Traditional physical therapy program OTHER

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

Respiratory training (study) group.; Traditional (control) group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Oculocerebral hypopigmentation syndrome type Preus

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• 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

  STUDY DIRECTOR

• Ahmed Elsisi, Assistant Professor

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

  STUDY DIRECTOR

Central Study Contacts

Mostafa Ali

CONTACT

+201004580951; mostafaaly.atia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 5, 2024
• Study Start: August 28, 2024
• Primary Completion: January 20, 2025
• Study Completion: February 25, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

EG (1)