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NCT Number: NCT07649330

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Location contact

Siou Pin Huang, PT (Physical Therapist)

CONTACT

[email protected]

+886 988 366 335

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

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

    • Maximum Inspiratory Pressure (MIP): Unit : cmH₂O
    • Maximum Expiratory Pressure (MEP): Unit : cmH₂O

Secondary outcomes

  1. 1. Forced Vital Capacity (FVC)

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

    • Forced Vital Capacity (FVC) Unit of Measure: liters (L)
  2. Forced Expiratory Volume in 1 second (FEV1)

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

    Forced Expiratory Volume in 1 Second (FEV1) Unit of Measure: liters (L)

  3. FEV1/FVC ratio

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

    FEV1/FVC Ratio Unit of Measure: percentage (%)

  4. Maximal Voluntary Ventilation (MVV)

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

    Maximal Voluntary Ventilation (MVV) Unit of Measure: liters/minute (L/min)

  5. Middle and Lower chest wall mobility

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

    Chest Wall Mobility Unit of Measure: centimeters (cm)

  6. Diaphragm and sternocleidomastoid surface electromyography (sEMG)

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

    Diaphragm Surface Electromyography Activity Sternocleidomastoid Surface Electromyography Activity Unit of Measure: microvolts (µV)

  7. Pain intensity

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

    Pain intensity measured using the Numeric Rating Scale (NRS). (0-10)

Study contacts

Contact information is provided by the study sponsor or research team.

Siou Pin Huang, PT (Physical Therapist)

CONTACT

[email protected]

+886 988 366 335

Sponsors and collaborators

Lead sponsor

Siou-Pin Huang

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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