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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07645027
Enrollment
42
Registered
2026-06-12
Start date
2026-05-01
Completion date
2026-08-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cord Injuries Spinal, Cervical Spinal Cord Injury

Keywords

Cervical cord injury, Dyspnea, Incentive spirometer, Low volume nose resistance breathing exercise

Brief summary

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.

Detailed description

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.

Interventions

DEVICEAcapella device plus Incentive Spirometry

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

exercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Function Tests (FVC, FEV1),5 weeksPFTs 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.
Modified Borg Dyspnea Scale5 weeksThe Modified Borg Scale is a validated tool used to measure perceived breathlessness.

Secondary

MeasureTime frameDescription
Cough Frequency Scale5 weeksThe 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.
Sputum Grading Scale.5 weeksThis scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.

Countries

Pakistan

Contacts

CONTACTMuhammad Iqbal Tariq, Phd
iqbal.tariq@riphah.edu.pk333826752
CONTACTMisdaq Batool, MS PT
misdaaqbatool@yahoo.com.ph03496166611
PRINCIPAL_INVESTIGATORArjumand Bano, MS

Riphah International University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026