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

8. juni 2026 oppdatert av: Riphah International University

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

42

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 40100

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Low Volume Nose Resistance Breathing Exercises (LVNRBE)
Receives LVNRBE using an Acapella device plus IS for 20 minutes, three times daily, five days a week for four weeks
Enhet: 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
Aktiv komparator: conventional respiratory physiotherapy
(Control): Receives conventional respiratory physiotherapy with the same frequency and duration.
Atferdsmessig: conventional respiratory physiotherapy
exercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pulmonary Function Tests (FVC, FEV1),
Tidsramme: 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.
5 weeks
Modified Borg Dyspnea Scale
Tidsramme: 5 weeks
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
5 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cough Frequency Scale
Tidsramme: 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.
5 weeks
Sputum Grading Scale.
Tidsramme: 5 weeks
This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.
5 weeks

Samarbeidspartnere og etterforskere

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Sponsor

Riphah International University

Etterforskere

  • Hovedetterforsker: Arjumand Bano, MS, Riphah International University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REC/RCR & AHS/25/0305

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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