- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Siou Pin Huang, PT (Physical Therapist)
- Numero di telefono: +886 988 366 335
- Email: qaz9650921@gmail.com
Luoghi di studio
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Kaohsiung City, Taiwan
- Reclutamento
- Kaohsiung Veterans General Hospital
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Contatto:
- Siou Pin Huang, PT (Physical Therapist)
- Numero di telefono: +886 988 366 335
- Email: qaz9650921@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: (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.
|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Lasso di tempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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)
Lasso di tempo: 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
Lasso di tempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
FEV1/FVC Ratio Unit of Measure: percentage (%)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
Maximal Voluntary Ventilation (MVV)
Lasso di tempo: 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
Lasso di tempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dissezione, vaso sanguigno
- Sindrome aortica acuta
- Malattie vascolari
- Malattia cardiovascolare
- Malattie cardiache
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattia coronarica
- Ischemia miocardica
- Malattie dell'aorta
- Aneurisma
- Disfunsione dell'arteria coronaria
- Aneurisma aortico
- Dissezione aortica
- Malattie delle valvole cardiache
Altri numeri di identificazione dello studio
- AF02-008/15.1
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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