- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627009
Upper Extremity Exercises With and Without Deep Breathing After Cardiac Surgery (ROM-DB)
Evaluation of the Effects of Upper Extremity Range of Motion Exercises Performed With and Without Deep Breathing on Respiratory Parameters After Cardiac Surgery: A Randomized Trials
연구 개요
상태
정황
상세 설명
Postoperative pulmonary complications are common after cardiac surgery and may include atelectasis, pulmonary edema, hypoxemia, reduced lung volumes, impaired thoracic mobility, and respiratory muscle dysfunction. Median sternotomy, postoperative pain, fear of movement, prolonged immobilization, and changes in respiratory mechanics may contribute to impaired pulmonary function during the early postoperative period.
Postoperative physiotherapy, early mobilization, breathing exercises, and range of motion exercises are commonly included in standard postoperative care after cardiac surgery. Deep breathing exercises are recommended to support lung expansion and improve pulmonary function, while upper extremity range of motion exercises may contribute to thoracic mobility, postural drainage, secretion clearance, and functional recovery. However, evidence regarding the immediate effects of standardized upper extremity exercises on respiratory parameters after open cardiac surgery remains limited.
Previous studies have examined respiratory physiotherapy, mobilization, and exercise-based interventions after cardiac surgery, and some evidence suggests potential benefits on lung function and inspiratory capacity. Nevertheless, the specific contribution of upper extremity range of motion exercises performed with versus without deep breathing has not been sufficiently clarified. This study is designed to compare the immediate effects of these two standardized exercise protocols on oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea in patients after cardiac surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kocaeli
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İzmit, Kocaeli, 터키 (Türkiye), 41100
- 모병
- Kocaeli University
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연락하다:
- Yasemin Özhanlı
- 전화번호: 05393094695
- 이메일: yasemin.ozhanli@kocaeli.edu.tr
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연락하다:
- MUSTAFA CANİKOĞLU, Assist. Prof.
- 전화번호: 05424257817
- 이메일: mustafa.canikoglu@kocaeli.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- underwent elective open-heart surgery,
- stayed in the cardiovascular ICU for at least 2 nights post-operatively,
- had FiO2 below 40% (Spo2 will be kept above 92),
- were conscious,
- could speak Turkish,
- were willing to participate in the study.
Exclusion Criteria:
underwent another thoracic surgery or repeat surgery simultaneously,
- had any limb loss,
- underwent prolonged immobilization and intubation,
- developed serious complications such as infection or respiratory failure after surgery,
- had problems such as paresthesia, plegia, etc. after stroke, or had diseases such as Parkinson's that affect the level of relaxa
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Deep Breathing followed by ROM with Deep Breathing
Participants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing.
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Participants will perform slow and deep breathing exercises in a sitting position.
Measurements will be recorded before and immediately after the intervention.
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering.
The exercise will be repeated five times in a sitting position.
Measurements will be recorded before and immediately after the intervention.
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활성 비교기: ROM with Deep Breathing followed by Deep Breathing
Participants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone.
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Participants will perform slow and deep breathing exercises in a sitting position.
Measurements will be recorded before and immediately after the intervention.
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering.
The exercise will be repeated five times in a sitting position.
Measurements will be recorded before and immediately after the intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Oxygen Saturation SpO₂
기간: Baseline and immediately after each intervention.
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Oxygen saturation will be measured using a bedside clinical monitor or pulse oximeter.
SpO₂ represents the percentage of hemoglobin saturated with oxygen in the blood and will be recorded as a percentage.
Higher values indicate better oxygenation.
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Baseline and immediately after each intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Respiratory Rate
기간: Baseline and immediately after each intervention.
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Respiratory rate will be assessed as the number of breaths taken per minute and recorded as breaths per minute
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Baseline and immediately after each intervention.
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Change in Heart Rate
기간: Baseline and immediately after each intervention.
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Heart rate will be measured using a bedside clinical monitor and recorded as beats per minute.
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Baseline and immediately after each intervention.
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Change in Pain Intensity Assessed by the Numeric Rating Scale
기간: Baseline and immediately after each intervention.
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Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10. Higher scores indicate greater pain intensity.
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Baseline and immediately after each intervention.
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공동 작업자 및 조사자
수사관
- 수석 연구원: MUSTAFA CANİKOĞLU, Assist. Prof, Kocaeli University
- 연구 의자: Yasemin Özhanlı, Assist. Prof, Kocaeli University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
기타 연구 ID 번호
- KOU-CVS-ROM-DB-2026
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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