Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
調査の概要
状態
条件
詳細な説明
Burn injuries may lead to physical limitations, functional loss, and respiratory problems. In individuals with upper extremity burns, pain, scar tissue, and reduced mobility of the shoulder girdle and chest wall may affect breathing mechanics and respiratory muscle performance. These changes may reduce ventilatory capacity and functional capacity during daily activities.
This randomized controlled clinical study will investigate the effects of a pulmonary rehabilitation program in adults with upper extremity burns. The study will be conducted at the Burn Center of Kartal Dr. Lütfi Kırdar City Hospital. Adults aged 18 to 65 years who had an upper extremity burn injury 3 to 12 months before enrollment and who meet the eligibility criteria will be included.
A total of 64 participants will be randomly assigned to two groups: a pulmonary rehabilitation group and a control group. The pulmonary rehabilitation group will receive respiratory muscle training combined with upper extremity aerobic exercises. The control group will receive a conventional exercise program. The intervention period will last 6 weeks.
Participants will be assessed at three time points: before the intervention, at week 3, and after the 6-week intervention. Respiratory function will be assessed using spirometry, including forced vital capacity, forced expiratory volume in one second, and maximum voluntary ventilation. Respiratory muscle activity will be evaluated using surface electromyography. Respiratory muscle thickness and diaphragm excursion will be assessed using ultrasonography. Functional capacity will be measured with the 6-minute walk test.
The study aims to determine whether pulmonary rehabilitation can improve respiratory function, respiratory muscle activity, respiratory muscle morphology, and functional capacity in individuals with upper extremity burns.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Kartal
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Istanbul、Kartal、トルコ（Türkiye）、34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 to 65 years
- History of upper extremity burn injury 3 to 12 months before enrollment
- Clinically stable condition, including oxygen saturation greater than 92% and cardiac stability
- Ability to communicate and follow instructions, with no hearing, cognitive, or motor communication impairment
- Voluntary agreement to participate in the study and signing the informed consent form
Exclusion Criteria:
- Burns involving the lower extremity, trunk, or head and neck regions
- History of chronic pulmonary, cardiac, neurological, or musculoskeletal disease
- Dependence on mechanical ventilation or respiratory support
- Severe psychiatric disorder or cognitive impairment
- Pregnancy
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
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Participants in the experimental group will receive a 6-week pulmonary rehabilitation program in addition to the conventional exercise program.
The pulmonary rehabilitation program will include respiratory muscle training and upper extremity aerobic exercises.
Respiratory muscle training will be performed to improve inspiratory and expiratory muscle performance.
Upper extremity aerobic exercises will be planned according to the participant's clinical status and tolerance, with the aim of improving respiratory function, chest wall mobility, exercise tolerance, and functional capacity.
Exercises will be progressed gradually during the intervention period, and participants will be monitored for dyspnea, fatigue, oxygen desaturation, and pain during the sessions.
Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
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アクティブコンパレータ：Conventional Exercise Group
Participants in this group will receive a 6-week conventional exercise program.
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Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
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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 |
|---|---|---|
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Change in Forced Vital Capacity
時間枠：Baseline, week 3, and week 6
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Pulmonary function will be assessed using forced vital capacity measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced vital capacity will be reported in liters.
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Baseline, week 3, and week 6
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Change in Forced Expiratory Volume in One Second
時間枠：Baseline, week 3, and week 6
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Pulmonary function will be assessed using forced expiratory volume in one second measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced expiratory volume in one second will be reported in liters.
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Baseline, week 3, and week 6
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Change in Maximum Voluntary Ventilation
時間枠：Baseline, week 3, and week 6
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Pulmonary function will be assessed using maximum voluntary ventilation measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Maximum voluntary ventilation will be reported in liters per minute.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Inspiration
時間枠：Baseline, week 3, and week 6
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Diaphragm thickness during inspiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during inspiration will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Expiration
時間枠：Baseline, week 3, and week 6
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Diaphragm thickness during expiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during expiration will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in Diaphragm Excursion
時間枠：Baseline, week 3, and week 6
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Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time.
Diaphragm excursion will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in 6-Minute Walk Distance
時間枠：Baseline, week 3, and week 6
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Functional capacity will be assessed using the 6-minute walk test.
The distance walked during the test will be recorded in meters.
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Baseline, week 3, and week 6
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sümeyye Akçay、Fenerbahçe University
研究記録日
主要日程の研究
研究開始 (推定)
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
- KartalH
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?
IPD プランの説明
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。
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