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NCT Number: NCT07645027

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

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.

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Key information

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagonosed cervical spine injury C4-C7
  • Age 18-38 years
  • Undergoing in-patient rehabilitation
  • No previous history of severe pulmonary disease
  • Disease duration <1 year
  • Ability to give informed consent
  • Road Accident

Exclusion criteria

  • Uncontrolled hypertension
  • Other Neuromuscular disease
  • Stage 3-4 pressure wound
  • Clinical instability
  • Traumatic Brain injury

Treatment and study plan

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

Primary outcomes

  1. Pulmonary Function Tests (FVC, FEV1),

    Time frame: 5 weeks

    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.

  2. Modified Borg Dyspnea Scale

    Time frame: 5 weeks

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

Secondary outcomes

  1. Cough Frequency Scale

    Time frame: 5 weeks

    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.

  2. Sputum Grading Scale.

    Time frame: 5 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Misdaq Batool, MS PT

CONTACT

[email protected]

03496166611

Muhammad Iqbal Tariq, Phd

CONTACT

[email protected]

333826752

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Low Volume Nose Resistance Breathing Exercise With Incentive Spirometer on Pulmonary Function Test, Dyspnea, Cough and Sputum in Patient With Cervical Spinal Cord Injuries

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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