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

NCT07645027 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0305
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spinal Cord Injury; Cervical Cord Injuries Spinal

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  5 weeks

• Modified Borg Dyspnea Scale

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

  5 weeks

Secondary Outcomes (2)

• Cough Frequency Scale

  5 weeks

• Sputum Grading Scale.

  5 weeks

Study Arms (2)

Low Volume Nose Resistance Breathing Exercises (LVNRBE)

EXPERIMENTAL

Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks

Device: Acapella device plus Incentive Spirometry

conventional respiratory physiotherapy

ACTIVE COMPARATOR

(Control): Receives conventional respiratory physiotherapy with the same frequency and duration.

Behavioral: conventional respiratory physiotherapy

Interventions

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

conventional respiratory physiotherapy

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

Low Volume Nose Resistance Breathing Exercises (LVNRBE)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah hoapital

Lahore, Punjab Province, 40100, Pakistan

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arjumand Bano, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq, Phd

CONTACT

333826752; iqbal.tariq@riphah.edu.pk

Misdaq Batool, MS PT

CONTACT

03496166611; misdaaqbatool@yahoo.com.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)