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

Official 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

Overview

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

• 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

Primary outcome measures

• Pulmonary Function Tests (FVC, FEV1), [Time frame: 5 weeks]
• Modified Borg Dyspnea Scale [Time frame: 5 weeks]

Secondary outcome measures (2)

• Cough Frequency Scale [Time frame: 5 weeks]
• Sputum Grading Scale. [Time frame: 5 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Jinnah hoapital — Lahore

Identifiers

NCT: NCT07645027 · REC/RCR & AHS/25/0305

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗