Effects of Myofascial Release on Cardiac Patients After Median Sternotomy

NCT07649330 | Recruiting

• 1 other identifier: AF02-008/15.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Aneurysm and Dissection; Coronary Artery Disease (CAD); Valve Heart Disease

Keywords

Median Sternotomy; Cardiac Surgery; Coronary Artery Disease; Aortic Aneurysm; Aortic Dissection; Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

  1. Maximum Inspiratory Pressure (MIP): Unit : cmH₂O 2. Maximum Expiratory Pressure (MEP): Unit : cmH₂O

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

Secondary Outcomes (7)

• 1. Forced Vital Capacity (FVC)

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

• Forced Expiratory Volume in 1 second (FEV1)

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

• FEV1/FVC ratio

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

• Maximal Voluntary Ventilation (MVV)

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

• Middle and Lower chest wall mobility

  1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

Study Arms (2)

(Control Group) Arm Title: Control Group - Routine Physical Therapy

ACTIVE COMPARATOR

Routine Physical Therapy

Behavioral: Routine Physical therapy

Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy

EXPERIMENTAL

Experimental: (Intervention Group) Arm Title: Intervention Group - Myofascial Release+Routine Physical Therapy

Behavioral: myofascial release+Routine Physical Therapy

Interventions

myofascial release+Routine Physical Therapy BEHAVIORAL

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.

Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy

Routine Physical therapy BEHAVIORAL

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.

(Control Group) Arm Title: Control Group - Routine Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siou-Pin Huang: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Coronary Artery Disease; Heart Valve Diseases; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Siou Pin Huang, PT (Physical Therapist)

CONTACT

+886 988 366 335; qaz9650921@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist, Department of Physical Therapy, Kaohsiung Veterans General Hospital

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: June 16, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)