Low Volume Nose Resistance Breathing Exercise With Incentive Spirometer in Patient With Cervical Spinal Cord Injuries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-38
SponsorRiphah International University

About this trial

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.

* Group A (Intervention): Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks. * Group B (Control): Receives conventional respiratory physiotherapy with the same frequency and duration.

Outcomes will be assessed pre- and post-intervention using:

* Pulmonary Function Tests (FVC, FEV1), * Modified Borg Dyspnea Scale, * Cough Frequency Scale, * Sputum Grading Scale.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagonosed cervical spine injury C4-C7

Age 18-38 years

Undergoing in-patient rehabilitation

No previous history of severe pulmonary disease

Disqualifiers

Uncontrolled hypertension

Other Neuromuscular disease

Stage 3-4 pressure wound

Clinical instability

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Low Volume Nose Resistance Breathing Exercises (LVNRBE)Experimental treatment 1 intervention
Group B: conventional respiratory physiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 weeks
2

Modified Borg Dyspnea Scale

The Modified Borg Scale is a validated tool used to measure perceived breathlessness.

Time frame
5 weeks

Secondary outcomes

1

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.

Time frame
5 weeks
2

Sputum Grading Scale.

This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.

Time frame
5 weeks

Other outcomes

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