- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07645027
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
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhammad Iqbal Tariq, pHD
- 전화번호: 333826752
- 이메일: iqbal.tariq@riphah.edu.pk
연구 연락처 백업
- 이름: Misdaq Batool, MS PT
- 전화번호: 03496166611
- 이메일: misdaaqbatool@yahoo.com.ph
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 40100
- 모병
- Jinnah hoapital
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연락하다:
- Misdaq Batool, MS PT
- 전화번호: 03466584498
- 이메일: misdaaqbatool@yahoo.com.ph
-
연락하다:
- Haney Arif, MS PT
- 전화번호: 03334572500
- 이메일: Haneyarif67@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
|
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
|
|
활성 비교기: conventional respiratory physiotherapy
(Control): Receives conventional respiratory physiotherapy with the same frequency and duration.
|
exercises were performed for 20 minutes three times daily, five times a week, over a period of four weeks under supervision
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pulmonary Function Tests (FVC, FEV1),
기간: 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
기간: 5 weeks
|
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
|
5 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cough Frequency Scale
기간: 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
|
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Sputum Grading Scale.
기간: 5 weeks
|
This scale is particularly relevant in cervical SCI patients who are at risk for mucus retention due to impaired expiratory function.
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5 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Arjumand Bano, MS, Riphah International University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- REC/RCR & AHS/25/0305
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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