- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-post: qaz9650921@gmail.com
Studiesteder
-
-
-
Kaohsiung City, Taiwan
- Rekruttering
- Kaohsiung Veterans General Hospital
-
Ta kontakt med:
- Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-post: qaz9650921@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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.
|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
1. Forced Vital Capacity (FVC) Unit of Measure: liters (L)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
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
|
|
FEV1/FVC ratio
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
FEV1/FVC Ratio Unit of Measure: percentage (%)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
Maximal Voluntary Ventilation (MVV)
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Maximal Voluntary Ventilation (MVV) Unit of Measure: liters/minute (L/min)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
Middle and Lower chest wall mobility
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Chest Wall Mobility Unit of Measure: centimeters (cm)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
Diaphragm and sternocleidomastoid surface electromyography (sEMG)
Tidsramme: 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)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
Pain intensity
Tidsramme: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Pain intensity measured using the Numeric Rating Scale (NRS).
(0-10)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AF02-008/15.1
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