- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-mail: qaz9650921@gmail.com
Studiesteder
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Kaohsiung City, Taiwan
- Rekruttering
- Kaohsiung Veterans General Hospital
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Kontakt:
- Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-mail: qaz9650921@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: (Control Group) Arm Title: Control Group - Routine Physical Therapy
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.
|
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Eksperimentel: Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy
Experimental: (Intervention Group) Arm Title: Intervention Group - 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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1. Forced Vital Capacity (FVC) Unit of Measure: liters (L)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Forced Expiratory Volume in 1 second (FEV1)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Forced Expiratory Volume in 1 Second (FEV1) Unit of Measure: liters (L)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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FEV1/FVC ratio
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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FEV1/FVC Ratio Unit of Measure: percentage (%)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Maximal Voluntary Ventilation (MVV)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Maximal Voluntary Ventilation (MVV) Unit of Measure: liters/minute (L/min)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Middle and Lower chest wall mobility
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Chest Wall Mobility Unit of Measure: centimeters (cm)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Diaphragm and sternocleidomastoid surface electromyography (sEMG)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Diaphragm Surface Electromyography Activity Sternocleidomastoid Surface Electromyography Activity Unit of Measure: microvolts (µV)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Pain intensity
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Pain intensity measured using the Numeric Rating Scale (NRS).
(0-10)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AF02-008/15.1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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