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This randomized clinical trial aims to evaluate the effectiveness of combining Low Volume Nose Resistance Breathing Exercises (LVNRBE) with Incentive Spirometry (IS) on respiratory outcomes in patients with cervical spinal cord injury (SCI). Respiratory complications are a major concern in cervical SCI due to impaired respiratory muscle function, leading to reduced lung volumes, dyspnea, ineffective cough, and sputum retention. The study will recruit 42 inpatients aged 18-38 years with cervical SCI (C4-C7), randomly divided into two groups: Data Analysis: Statistical tests (paired and independent t-tests) will determine intra- and intergroup differences using SPSS v25, with significance set at p < 0.05.
Outcomes will be assessed pre- and post-intervention using:
Spinal cord injuries (SCI), particularly at the cervical level, often lead to compromised respiratory function due to partial or complete paralysis of respiratory muscles. This impairment significantly affects pulmonary function, increases dyspnea, and reduces overall quality of life. Respiratory complications remain one of the leading causes of morbidity in individuals with cervical SCI.
Various therapeutic approaches, including breathing exercises and assistive devices, have been used to enhance pulmonary rehabilitation. Pulmonary rehabilitation strategies, including breathing exercises and incentive spirometry, are essential in improving respiratory function in this population.
These techniques help enhance lung expansion, improve airway clearance, and reduce the risk of pulmonary complications, thereby supporting better respiratory health and functional outcomes The primary objective of this study is to evaluate the effect of LVNRBE combined with IS on pulmonary function test (PFT) parameters, dyspnea levels, cough effectiveness, and sputum characteristics in patients with cervical SCI undergoing inpatient rehabilitation. The study also aims to compare outcomes between an intervention group receiving incentive spirometry and a control group receiving conventional physiotherapy. This randomized controlled trial will include patients aged 18 to 65 years with cervical SCI (C4-C7), disease duration less than one year, and the ability to give informed consent. Participants will be randomly divided into two groups. Group A (intervention group) will perform nasal resistance breathing exercises with incentive spirometer for 20 minutes daily 3 time, five times per week, over a period of four weeks. Group B (control group) will receive conventional respiratory physiotherapy three time per week over a period of four weeks without the device. Baseline and post-intervention (week 4) data will be collected using pulmonary function tests (PFTs), a dyspnea scale (modified Borg), cough (Cough frequency scale) and sputum grading questionnaire. Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p < 0.05. The data will be analyzed using SPSS v 25.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Volume Nose Resistance Breathing Exercises (LVNRBE) | Experimental | Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks |
|
| conventional respiratory physiotherapy | Active Comparator | (Control): Receives conventional respiratory physiotherapy with the same frequency and duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acapella device plus Incentive Spirometry | Device | PFTs will be performed with Spirobank, a handheld digital spirometer, to measure respiratory parameters such as forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV ). These values help assess lung volumes, airflow, and respiratory muscle strength in spinal cord injured patients. They are highly valid and accepted internationally for assessing lung function. Test-retest reliability is strong, with correlation coefficients often exceeding 0.90 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function Tests (FVC, FEV1), | PFTs will be performed with Spirobank, a handheld digital spirometer, to measure respiratory parameters such as forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV ). These values help assess lung volumes, airflow, and respiratory muscle strength in spinal cord injured patients. They are highly valid and accepted internationally for assessing lung function. Test-retest reliability is strong, with correlation coefficients often exceeding 0.90. | 5 weeks |
| Modified Borg Dyspnea Scale | The Modified Borg Scale is a validated tool used to measure perceived breathlessness. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cough Frequency Scale | The Cough Frequency Scale (CFS) was used to assess the frequency of coughing episodes in patients with cervical spinal cord injury (SCI). It is a simple, subjective scale that grades cough occurrence based on patient report, typically ranging from no cough (0) to frequent coughing episodes interfering with daily activities. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Iqbal Tariq, Phd | Contact | 333826752 | iqbal.tariq@riphah.edu.pk | |
| Misdaq Batool, MS PT | Contact | 03496166611 | misdaaqbatool@yahoo.com.ph |
| Name | Affiliation | Role |
|---|---|---|
| Arjumand Bano, MS | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah hoapital | Recruiting | Lahore | Punjab Province | 40100 | Pakistan |
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| conventional respiratory physiotherapy | Behavioral | exercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision |
|
| Sputum Grading Scale. | This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function. | 5 weeks |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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