Respiratory Physiotherapy and PMR After Cardiac Surgery (RESP-PMR)

April 17, 2026 updated by: FATMA ÇAVDARCI, Istanbul Aydın University

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 three consecutive 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 three 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 Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fatma Cavdarcı, PhD Candidate
  • Phone Number: +905374590918
  • Email: cvdrcftm@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine Care
Participants in this group will receive routine postoperative care and standard cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.
Other: Routine Care
Standard postoperative care and routine cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.
Experimental: Respiratory Physiotherapy + PMR
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.
Other: Respiratory Physiotherapy
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.
Other: Progressive Muscle Relaxation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Aydın University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYU-PT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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