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- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Siou Pin Huang, PT (Physical Therapist)
- Numéro de téléphone: +886 988 366 335
- E-mail: qaz9650921@gmail.com
Lieux d'étude
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Kaohsiung City, Taïwan
- Recrutement
- Kaohsiung Veterans General Hospital
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Contact:
- Siou Pin Huang, PT (Physical Therapist)
- Numéro de téléphone: +886 988 366 335
- E-mail: qaz9650921@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: (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.
|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Délai: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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
|
|
Middle and Lower chest wall mobility
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Dissection, vaisseau sanguin
- Syndrome aortique aigu
- Maladies vasculaires
- Maladies cardiovasculaires
- Maladies cardiaques
- Artériosclérose
- Maladies artérielles occlusives
- Maladie coronarienne
- Ischémie myocardique
- Maladies aortiques
- Anévrisme
- Maladie de l'artère coronaire
- Anévrisme aortique
- Dissection de l'aorte
- Maladies des valves cardiaques
Autres numéros d'identification d'étude
- AF02-008/15.1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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