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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muhammad Iqbal Tariq, pHD
- 電話番号：333826752
- メール：iqbal.tariq@riphah.edu.pk
研究連絡先のバックアップ
- 名前：Misdaq Batool, MS PT
- 電話番号：03496166611
- メール：misdaaqbatool@yahoo.com.ph
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、40100
- 募集
- Jinnah hoapital
-
コンタクト：
- Misdaq Batool, MS PT
- 電話番号：03466584498
- メール：misdaaqbatool@yahoo.com.ph
-
コンタクト：
- Haney Arif, MS PT
- 電話番号：03334572500
- メール：Haneyarif67@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary Function Tests (FVC, FEV1),
時間枠：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
時間枠：5 weeks
|
The Modified Borg Scale is a validated tool used to measure perceived breathlessness.
|
5 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cough Frequency Scale
時間枠：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.
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Arjumand Bano, MS、Riphah International University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- REC/RCR & AHS/25/0305
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。