Cardiac SurgeryRESP-PMRNCT07542691
Respiratory Physiotherapy and PMR After Cardiac Surgery
A study testing Respiratory Physiotherapy, Progressive Muscle Relaxation and Routine Care in people with Cardiac Surgery and Dyspnea, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Dyspnea, Anxiety
- What is being tested?
- Respiratory Physiotherapy, Progressive Muscle Relaxation and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years who have undergone cardiac surgery
- Hemodynamically stable patients
- Patients able to cooperate and follow instructions
- Patients with postoperative dyspnea
- Patients who provide written informed consent
Who cannot join
- Patients with severe cognitive impairment or inability to cooperate
- Patients with neurological or psychiatric disorders affecting participation
- Patients requiring mechanical ventilation for prolonged periods
- Patients with unstable hemodynamic status
- Patients with contraindications to respiratory physiotherapy or exercise
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University
Istanbul, Istanbul, 34295
About this study
Official title: Effect of Respiratory Physiotherapy and Progressive Muscle Relaxation Exercises on Dyspnea, Anxiety, Hemodynamic Status and Delirium Symptoms After Cardiac Surgery: A Randomized Controlled Trial
This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over eleven days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.
Read the detailed description
This study is designed as a randomized controlled trial to investigate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients following cardiac surgery. A total of 116 adult patients who have undergone cardiac surgery will be recruited and randomly allocated into two groups: an intervention group and a control group.
The intervention group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, together with progressive muscle relaxation exercises, in addition to routine postoperative care. These interventions will be applied for 30 minutes per day over eleven consecutive days in the postoperative period. The control group will receive only routine postoperative care and standard cardiac rehabilitation procedures.
Outcome measures will include dyspnea assessed using the Modified Borg Scale, anxiety assessed using the State-Trait Anxiety Inventory, hemodynamic parameters including blood pressure, heart rate, respiratory rate, and oxygen saturation obtained from routine vital sign monitoring, and delirium symptoms assessed using the Nursing Delirium Screening Scale. Data will be collected at baseline and after the intervention period.
Inclusion criteria include patients aged 18 years and older who have undergone cardiac surgery and are able to participate in the interventions. Patients with severe orthopedic limitations, communication barriers, or medical contraindications to the interventions will be excluded. Participants may withdraw from the study at any time, and all procedures will be conducted in accordance with ethical standards and patient safety principles.
Randomization will be performed using a computer-based randomization method, and participants will be assigned to groups in a 1:1 ratio. Statistical analysis will be conducted using appropriate parametric and non-parametric tests, with a significance level set at p < 0.05.
- Conditions
- Cardiac Surgery, Dyspnea, Anxiety, Delirium
- Being tested
- Respiratory Physiotherapy, Progressive Muscle Relaxation, Routine Care
- Keywords
- Respiratory Physiotherapy, Progressive Muscle Relaxation, Cardiac Rehabilitation, Postoperative Care, Intensive Care Unit, Hemodynamic Parameters
- Medical subject headings
- Dyspnea, Anxiety Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory PhysiotherapyOther
Respiratory physiotherapy includes breathing exercises, postural drainage, percussion, and vibration techniques aimed at improving pulmonary function, facilitating secretion clearance, and enhancing oxygenation in postoperative cardiac surgery patients.
Progressive Muscle RelaxationOther
Progressive muscle relaxation is a systematic technique involving sequential contraction and relaxation of muscle groups combined with controlled breathing, aimed at reducing anxiety, improving psychological well-being, and promoting physiological relaxation.
Routine CareOther
Standard postoperative care and routine cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Active comparator | Participants in this group will receive routine postoperative care and standard cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises. Receives: Other: Routine Care |
| Respiratory Physiotherapy + PMR | Experimental | Participants in this group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, combined with progressive muscle relaxation exercises in addition to routine postoperative care. The intervention will be applied for 30 minutes per day over three consecutive days following cardiac surgery. Receives: Other: Respiratory Physiotherapy; Other: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea (Modified Borg Scale)
Dyspnea severity will be assessed using the Modified Borg Scale (MBS). The scale ranges from 0 (no dyspnea) to 10 (maximal dyspnea). Higher scores indicate greater perceived breathlessness. Measurements will be performed by a trained assessor under standardized conditions.
Measured: Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start5 May 2026
- Primary completion16 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two parallel groups: an intervention group receiving respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine care, and a control group receiving routine postoperative care only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA ÇAVDARCI, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542691
- Sponsor's protocol ID
- AYU-PT-2026-01
- Acronym
- RESP-PMR
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study does not include a plan for sharing de-identified individual-level data due to institutional policies and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Physiotherapy and Progressive Muscle Relaxation Exercises on Dyspnea, Anxiety, Hemodynamic Status and Delirium Symptoms After Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07542691
- Acronym / sponsor ID
- RESP-PMR / AYU-PT-2026-01
- Conditions
- Cardiac Surgery, Dyspnea, Anxiety, Delirium
- Keywords
- Respiratory Physiotherapy, Progressive Muscle Relaxation, Cardiac Rehabilitation, Postoperative Care, Intensive Care Unit, Hemodynamic Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 21 Apr 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 study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over eleven days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.
Detailed description
This study is designed as a randomized controlled trial to investigate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients following cardiac surgery. A total of 116 adult patients who have undergone cardiac surgery will be recruited and randomly allocated into two groups: an intervention group and a control group.
The intervention group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, together with progressive muscle relaxation exercises, in addition to routine postoperative care. These interventions will be applied for 30 minutes per day over eleven consecutive days in the postoperative period. The control group will receive only routine postoperative care and standard cardiac rehabilitation procedures.
Outcome measures will include dyspnea assessed using the Modified Borg Scale, anxiety assessed using the State-Trait Anxiety Inventory, hemodynamic parameters including blood pressure, heart rate, respiratory rate, and oxygen saturation obtained from routine vital sign monitoring, and delirium symptoms assessed using the Nursing Delirium Screening Scale. Data will be collected at baseline and after the intervention period.
Inclusion criteria include patients aged 18 years and older who have undergone cardiac surgery and are able to participate in the interventions. Patients with severe orthopedic limitations, communication barriers, or medical contraindications to the interventions will be excluded. Participants may withdraw from the study at any time, and all procedures will be conducted in accordance with ethical standards and patient safety principles.
Randomization will be performed using a computer-based randomization method, and participants will be assigned to groups in a 1:1 ratio. Statistical analysis will be conducted using appropriate parametric and non-parametric tests, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two parallel groups: an intervention group receiving respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine care, and a control group receiving routine postoperative care only.
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Active comparator | Other: Routine CareParticipants in this group will receive routine postoperative care and standard cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises. |
| Respiratory Physiotherapy + PMR | Experimental | Other: Respiratory Physiotherapy, Other: Progressive Muscle RelaxationParticipants in this group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, combined with progressive muscle relaxation exercises in addition to routine postoperative care. The intervention will be applied for 30 minutes per day over three consecutive days following cardiac surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-80 years who have undergone cardiac surgery
- Hemodynamically stable patients
- Patients able to cooperate and follow instructions
- Patients with postoperative dyspnea
- Patients who provide written informed consent
Key exclusion criteria (6 listed)
- Patients with severe cognitive impairment or inability to cooperate
- Patients with neurological or psychiatric disorders affecting participation
- Patients requiring mechanical ventilation for prolonged periods
- Patients with unstable hemodynamic status
- Patients with contraindications to respiratory physiotherapy or exercise
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 |
|---|---|---|
| Respiratory PhysiotherapyRespiratory physiotherapy includes breathing exercises, postural drainage, percussion, and vibration techniques aimed at improving pulmonary function, facilitating secretion clearance, and enhancing oxygenation in postoperative cardiac surgery patients. | Other | Respiratory Physiotherapy + PMR |
| Progressive Muscle RelaxationProgressive muscle relaxation is a systematic technique involving sequential contraction and relaxation of muscle groups combined with controlled breathing, aimed at reducing anxiety, improving psychological well-being, and promoting physiological relaxation. | Other | Respiratory Physiotherapy + PMR |
| Routine CareStandard postoperative care and routine cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises. | Other | Routine Care |
Primary outcome
Dyspnea (Modified Borg Scale)
Time frame: Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)
Dyspnea severity will be assessed using the Modified Borg Scale (MBS). The scale ranges from 0 (no dyspnea) to 10 (maximal dyspnea). Higher scores indicate greater perceived breathlessness. Measurements will be performed by a trained assessor under standardized conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study does not include a plan for sharing de-identified individual-level data due to institutional policies and ethical considerations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Physiotherapy, Progressive Muscle Relaxation and Routine Care in people with Cardiac Surgery and Dyspnea, run by Istanbul Aydın 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (Modified Borg Scale) (time frame: Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.