Effects of Myofascial Release on Cardiac Patients After Median Sternotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiou-Pin Huang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: (Control Group) Arm Title: Control Group - Routine Physical TherapyActive comparator 1 intervention
Group B: Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical TherapyExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

1. Forced Vital Capacity (FVC)

1\. Forced Vital Capacity (FVC) Unit of Measure: liters (L)

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

Forced Expiratory Volume in 1 second (FEV1)

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

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

FEV1/FVC ratio

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

Time frame
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
4

Maximal Voluntary Ventilation (MVV)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Siou-Pin Huang

Lead sponsor

Kaohsiung Veterans General Hospital.

Sponsor institution