- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-post: qaz9650921@gmail.com
Studieorter
-
-
-
Kaohsiung City, Taiwan
- Rekrytering
- Kaohsiung Veterans General Hospital
-
Kontakt:
- Siou Pin Huang, PT (Physical Therapist)
- Telefonnummer: +886 988 366 335
- E-post: qaz9650921@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Tidsram: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AF02-008/15.1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .