- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey (Türkiye), 41100
- Recruiting
- Kocaeli University
-
Contact:
- Yasemin Özhanlı
- Phone Number: 05393094695
- Email: yasemin.ozhanli@kocaeli.edu.tr
-
Contact:
- MUSTAFA CANİKOĞLU, Assist. Prof.
- Phone Number: 05424257817
- Email: mustafa.canikoglu@kocaeli.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Saturation SpO₂
Time Frame: Baseline and immediately after each intervention.
|
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.
|
Baseline and immediately after each intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Respiratory Rate
Time Frame: Baseline and immediately after each intervention.
|
Respiratory rate will be assessed as the number of breaths taken per minute and recorded as breaths per minute
|
Baseline and immediately after each intervention.
|
|
Change in Heart Rate
Time Frame: Baseline and immediately after each intervention.
|
Heart rate will be measured using a bedside clinical monitor and recorded as beats per minute.
|
Baseline and immediately after each intervention.
|
|
Change in Pain Intensity Assessed by the Numeric Rating Scale
Time Frame: Baseline and immediately after each intervention.
|
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10. Higher scores indicate greater pain intensity.
|
Baseline and immediately after each intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MUSTAFA CANİKOĞLU, Assist. Prof, Kocaeli University
- Study Chair: Yasemin Özhanlı, Assist. Prof, Kocaeli University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KOU-CVS-ROM-DB-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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