Effects of Myofascial Release on Cardiac Patients After Median Sternotomy

After deciding to join this study and signing the informed consent form, participants will undergo the following interventions:

All participants will receive a preoperative assessment (Tp) before surgery. Within five days after transferring from the ICU to the general ward, participants will receive a baseline assessment (T0). After completing seven sessions of myofascial release (MFR), a post-intervention assessment (T1) will be conducted.

Assessments include maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), pulmonary function tests, mid- and lower-thoracic mobility, surface electromyography (sEMG) to measure diaphragmatic and sternocleidomastoid muscle activity, and pain scores. Pulmonary function tests include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and maximum voluntary ventilation (MVV).

Participants will be randomly assigned to an intervention group or a control group. The intervention group will receive myofascial release therapy in addition to routine physical therapy in the general ward. Routine therapy includes daily physical therapy sessions such as out-of-bed activities, incentive spirometry training (Triflow), and functional exercises. The MFR intervention consists of three steps:

The therapist places both hands on the thoracic outlet, with the index and middle fingers above the clavicle.

One hand is placed on the anterior chest and the other hand parallel on the participant's back.

Both hands are placed on the anterolateral region of the thoracoabdominal diaphragm.

During each step, participants are instructed to take 10 slow, deep breaths and direct airflow toward the therapist's hands. Each session lasts approximately 15 minutes, once daily, for seven sessions.

The control group will receive only routine physical therapy (out-of-bed activities, incentive spirometry, and functional exercises) without additional myofascial release therapy.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease (CAD); Valve Heart Disease; Aortic Aneurysm and Dissection
• Intervention / Treatment: Behavioral: Routine Physical therapy; Behavioral: myofascial release+Routine Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siou Pin Huang, PT (Physical Therapist); Phone Number: +886 988 366 335; Email: qaz9650921@gmail.com

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Recruiting
    • Kaohsiung Veterans General Hospital
    • Contact: Siou Pin Huang, PT (Physical Therapist); Phone Number: +886 988 366 335; Email: qaz9650921@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Able to communicate verbally and follow instructions
• Diagnosed by a physician with coronary artery disease, valvular disease, or aortic disease
• Undergoing median sternotomy
• Able to provide informed consent

Exclusion Criteria:

• Presence of a cardiac pacemaker
• Presence of a ventricular assist device (VAD)
• Existing central nervous system disorders (e.g., hemorrhagic or ischemic stroke, spinal cord injury, traumatic brain injury)
• Cognitive impairment or inability to understand/follow instructions
• Diagnosed with chronic obstructive pulmonary disease (COPD)
• History of previous thoracic surgery
• ICU stay longer than 14 days

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (Control Group) Arm Title: Control Group - Routine Physical Therapy; Routine Physical Therapy	Behavioral: Routine Physical therapy; Participants in the control group will receive routine physical therapy only, including out-of-bed activities, incentive spirometry training (Triflow), and functional exercises. No additional myofascial release therapy will be provided.
Experimental: Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy; Experimental: (Intervention Group) Arm Title: Intervention Group - Myofascial Release+Routine Physical Therapy	Behavioral: myofascial release+Routine Physical Therapy; Participants in the intervention group will receive seven daily sessions of myofascial release (MFR), approximately 15 minutes each, in addition to routine physical therapy. Routine therapy includes out-of-bed activities, incentive spirometry training (Triflow), and functional exercises. The MFR procedure consists of three steps: Therapist places both hands on the thoracic outlet, with index and middle fingers above the clavicle. One hand is placed on the anterior chest and the other parallel on the participant's back. Both hands are placed on the anterolateral thoracoabdominal region. During each step, participants are instructed to take 10 slow, deep breaths, directing airflow toward the therapist's hands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)	Maximum Inspiratory Pressure (MIP): Unit : cmH₂O; Maximum Expiratory Pressure (MEP): Unit : cmH₂O	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Forced Vital Capacity (FVC)	1. Forced Vital Capacity (FVC) Unit of Measure: liters (L)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Forced Expiratory Volume in 1 second (FEV1)	Forced Expiratory Volume in 1 Second (FEV1) Unit of Measure: liters (L)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
FEV1/FVC ratio	FEV1/FVC Ratio Unit of Measure: percentage (%)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Maximal Voluntary Ventilation (MVV)	Maximal Voluntary Ventilation (MVV) Unit of Measure: liters/minute (L/min)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Middle and Lower chest wall mobility	Chest Wall Mobility Unit of Measure: centimeters (cm)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Diaphragm and sternocleidomastoid surface electromyography (sEMG)	Diaphragm Surface Electromyography Activity Sternocleidomastoid Surface Electromyography Activity Unit of Measure: microvolts (µV)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Pain intensity	Pain intensity measured using the Numeric Rating Scale (NRS). (0-10)	1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

Collaborators and Investigators

• Sponsor: Siou-Pin Huang

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiac Surgery; Valvular Heart Disease; Aortic Aneurysm; Aortic Dissection; Median Sternotomy
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Aortic Diseases; Aneurysm; Coronary Artery Disease; Aortic Aneurysm; Aortic Dissection; Heart Valve Diseases
• Other Study ID Numbers: AF02-008/15.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No