Cardiac SurgeryROM-DBNCT07627009
Upper Extremity Exercises With and Without Deep Breathing After Cardiac Surgery
A study testing Deep Breathing Exercise and Upper Extremity ROM Exercise Combined with Deep Breathing in people with Cardiac Surgery, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This randomized 2×2 crossover trial aims to evaluate the effects of upper extremity range of motion exercises performed with and without deep breathing on respiratory parameters in patients after open cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Deep Breathing Exercise and Upper Extremity ROM Exercise Combined with Deep Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
İzmit, Kocaeli, 41100
Yasemin Özhanlı, 05393094695, yasemin.ozhanli@kocaeli.edu.tr
MUSTAFA CANİKOĞLU, Assist. Prof., 05424257817, mustafa.canikoglu@kocaeli.edu.tr
About this study
Official title: 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
This randomized 2×2 crossover trial aims to evaluate the effects of upper extremity range of motion exercises performed with and without deep breathing on respiratory parameters in patients after open cardiac surgery. The study will include adult patients who underwent elective open cardiac surgery and are receiving postoperative care in the cardiovascular surgery intensive care unit. Each participant will perform both exercise protocols: upper extremity range of motion exercises alone and upper extremity range of motion exercises combined with deep breathing. The order of the two interventions will be randomized. Respiratory and clinical outcomes, including oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea, will be assessed before and after each intervention.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Deep Breathing Exercise, Upper Extremity ROM Exercise Combined with Deep Breathing
- Keywords
- Cardiac surgery, Range of motion exercise, Deep breathing exercise, Postoperative respiratory function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Breathing ExerciseBehavioural
Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.
Upper Extremity ROM Exercise Combined with Deep BreathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Breathing followed by ROM with Deep Breathing | Experimental | Participants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing. Receives: Behavioral: Deep Breathing Exercise; Behavioral: Upper Extremity ROM Exercise Combined with Deep Breathing |
| ROM with Deep Breathing followed by Deep Breathing | Active comparator | Participants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone. Receives: Behavioral: Deep Breathing Exercise; Behavioral: Upper Extremity ROM Exercise Combined with Deep Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Saturation SpO₂
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.
Measured: Baseline and immediately after each intervention.
Secondary outcomes (3)
Change in Respiratory Rate
Respiratory rate will be assessed as the number of breaths taken per minute and recorded as breaths per minute
Measured: Baseline and immediately after each intervention.
Change in Heart Rate
Heart rate will be measured using a bedside clinical monitor and recorded as beats per minute.
Measured: Baseline and immediately after each intervention.
Change in Pain Intensity Assessed by the Numeric Rating Scale
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10. Higher scores indicate greater pain intensity.
Measured: Baseline and immediately after each intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2025
- Primary completion2 Sep 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to one of two sequences. Each participant will receive both upper extremity exercise protocols, with and without deep breathing, in a 2×2 crossover design.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSTAFA CANIKOGLU, Kocaeli University
- Investigators
- MUSTAFA CANİKOĞLU, Assist. Prof, Principal investigator, Kocaeli UniversityYasemin Özhanlı, Assist. Prof, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627009
- Sponsor's protocol ID
- KOU-CVS-ROM-DB-2026
- Acronym
- ROM-DB
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amin R, Alaparthi GK, Samuel SR, Bairapareddy KC, Raghavan H, Vaishali K. Effects of three pulmonary ventilation regimes in patients undergoing coronary artery bypass graft surgery: a randomized clinical trial. Sci Rep. 2021 Mar 24;11(1):6730. doi: 10.1038/s41598-021-86281-4.
PubMed 33762655
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07627009
- Acronym / sponsor ID
- ROM-DB / KOU-CVS-ROM-DB-2026
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Range of motion exercise, Deep breathing exercise, Postoperative respiratory function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized 2×2 crossover trial aims to evaluate the effects of upper extremity range of motion exercises performed with and without deep breathing on respiratory parameters in patients after open cardiac surgery. The study will include adult patients who underwent elective open cardiac surgery and are receiving postoperative care in the cardiovascular surgery intensive care unit. Each participant will perform both exercise protocols: upper extremity range of motion exercises alone and upper extremity range of motion exercises combined with deep breathing. The order of the two interventions will be randomized. Respiratory and clinical outcomes, including oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea, will be assessed before and after each intervention.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two sequences. Each participant will receive both upper extremity exercise protocols, with and without deep breathing, in a 2×2 crossover design.
| Arm | Type | Receives |
|---|---|---|
| Deep Breathing followed by ROM with Deep Breathing | Experimental | Behavioral: Deep Breathing Exercise, Behavioral: Upper Extremity ROM Exercise Combined with Deep BreathingParticipants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing. |
| ROM with Deep Breathing followed by Deep Breathing | Active comparator | Behavioral: Deep Breathing Exercise, Behavioral: Upper Extremity ROM Exercise Combined with Deep BreathingParticipants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Breathing ExerciseParticipants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention. | Behavioural | Deep Breathing followed by ROM with Deep Breathing, ROM with Deep Breathing followed by Deep Breathing |
| Upper Extremity ROM Exercise Combined with Deep BreathingParticipants 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. | Behavioural | Deep Breathing followed by ROM with Deep Breathing, ROM with Deep Breathing followed by Deep Breathing |
Primary outcome
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.
3 secondary outcomes
Change in Respiratory Rate
Time frame: Baseline and immediately after each intervention.
Change in Heart Rate
Time frame: Baseline and immediately after each intervention.
Change in Pain Intensity Assessed by the Numeric Rating Scale
Time frame: Baseline and immediately after each intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 33762655Amin R, Alaparthi GK, Samuel SR, Bairapareddy KC, Raghavan H, Vaishali K. Effects of three pulmonary ventilation regimes in patients undergoing coronary artery bypass graft surgery: a randomized clinical trial. Sci Rep. 2021 Mar 24;11(1):6730. doi: 10.1038/s41598-021-86281-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MUSTAFA CANİKOĞLU, Assist. Prof principal investigator
Kocaeli University
Yasemin Özhanlı, Assist. Prof study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Breathing Exercise and Upper Extremity ROM Exercise Combined with Deep Breathing in people with Cardiac Surgery, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen Saturation SpO₂ (time frame: Baseline and immediately after each intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.