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临床试验/NCT07649330
NCT07649330招募中不适用

Effects of Myofascial Release on Cardiac Patients After Median Sternotomy

Siou-Pin Huang1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

(Control Group) Arm Title: Control Group - Routine Physical Therapy

Active Comparator

Routine Physical Therapy

干预措施: Routine Physical therapy (Behavioral)

Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy

Experimental

Experimental: (Intervention Group) Arm Title: Intervention Group - Myofascial Release+Routine Physical Therapy

干预措施: myofascial release+Routine Physical Therapy (Behavioral)

结局指标

主要结局

Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

时间窗: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1

1. Maximum Inspiratory Pressure (MIP): Unit : cmH₂O 2. Maximum Expiratory Pressure (MEP): Unit : cmH₂O

次要结局

  • 1. Forced Vital Capacity (FVC)(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • Forced Expiratory Volume in 1 second (FEV1)(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • FEV1/FVC ratio(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • Maximal Voluntary Ventilation (MVV)(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • Middle and Lower chest wall mobility(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • Diaphragm and sternocleidomastoid surface electromyography (sEMG)(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)
  • Pain intensity(1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1)

研究者

发起方
Siou-Pin Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Siou-Pin Huang

Physical Therapist, Department of Physical Therapy, Kaohsiung Veterans General Hospital

Kaohsiung Veterans General Hospital.

研究点 (1)

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