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

NCT07645027 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Cervical Spinal Cord Injury
  • Cervical Cord Injuries Spinal

Interventions

DEVICE

Acapella 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

BEHAVIORAL

conventional respiratory physiotherapy

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

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Arjumand Bano, MS · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645027 on ClinicalTrials.gov