Aortic Aneurysm and DissectionNCT07649330
Effects of Myofascial Release on Cardiac Patients After Median Sternotomy
A study testing myofascial release+Routine Physical Therapy and Routine Physical therapy in people with Aortic Aneurysm and Dissection and Coronary Artery Disease (CAD), run by Siou-Pin Huang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD), Valve Heart Disease
- What is being tested?
- myofascial release+Routine Physical Therapy and Routine Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Siou Pin Huang, PT (Physical Therapist), +886 988 366 335, qaz9650921@gmail.com
About this study
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.
Read more
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.
- Being tested
- myofascial release+Routine Physical Therapy, Routine Physical therapy
- Keywords
- Median Sternotomy, Cardiac Surgery, Coronary Artery Disease, Aortic Aneurysm, Aortic Dissection, Valvular Heart Disease
- Medical subject headings
- Aortic Dissection, Coronary Artery Disease, Heart Valve Diseases, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial release+Routine Physical TherapyBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| (Control Group) Arm Title: Control Group - Routine Physical Therapy | Active comparator | Routine Physical Therapy Receives: 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 Receives: Behavioral: myofascial release+Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
- Maximum Inspiratory Pressure (MIP): Unit : cmH₂O
- Maximum Expiratory Pressure (MEP): Unit : cmH₂O
Measured: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Secondary outcomes (7)
1. Forced Vital Capacity (FVC)
- Forced Vital Capacity (FVC) Unit of Measure: liters (L)
Measured: 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)
Measured: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
FEV1/FVC ratio
FEV1/FVC Ratio Unit of Measure: percentage (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start25 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm and DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siou-Pin Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Siou-Pin Huang, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649330
- Sponsor's protocol ID
- AF02-008/15.1
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No