Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With Moderate COVID 19 Inside Intensive Care Unit, With a Complementary Home Telerehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Lab Investigations
研究概览
简要总结
Objective: To compare low-level laser therapy and myofascial release in reducing inflammation and functional recovery in critically ill COVID-19 patients with 3-month home-based telerehabilitation assessment.
Participants: One hundred two COVID-19 patients aged 45-60 years randomized into three groups: low-level laser therapy (n=34), myofascial release (n=34), and control (n=34).
Intervention: Intensive care unit-based low-level laser therapy, myofascial release, or standard physiotherapy with medical treatment. Following discharge, all participants received 12 weeks of multidimensional home-based telerehabilitation incorporating patient education, breathing exercises, inspiratory muscle training, limb strengthening, aerobic training, and trunk control.
Outcomes: Primary outcomes were ferritin and D-dimer levels. Secondary outcomes included C-reactive protein, interleukin-6, white blood cell counts, maximum inspiratory pressure, six-minute walk test, bilateral knee strength, dyspnea perception, fatigue severity, and oxygen saturation. All measured at baseline, discharge, and 3 months. Intensive care unit length of stay and physiotherapy sessions measured at discharge.
详细描述
One hundred-two COVID 19 patients (56 men and 46 women) aged 45-60 years were recruited from the Al Kasr Al Ainy teaching hospitals ICUs. All patients were informed of the study, risks, and expected benefits before signing the informed consent form. The low-level laser therapy group (LLLT) consisted of 34 patients, who received low-level laser therapy, traditional physiotherapy, medical treatment and the myofascial release group (MR) consisted of 34 patients, who received myofascial release techniques, traditional physiotherapy, and medical treatment; and the control group (C) consisted of 34 patients, who received traditional physiotherapy and medical treatment only. After discharge all patients received home multidimension telerehabilitation program.
The eligibility criteria were as follows: (I) Patients aged from 45 to 60 years old, (II) Diagnosed by CT or PCR as positive COVID 19, (III) Moderate cases of COVID-19 (According to CO-RA DS Scale).22 (IV) on low flow rate oxygen supply Exclusion criteria were (I) patients on Invasive Mechanical Ventilation, (II) Hemodynamically Unstable with inotropic support; (III) Septic Shock; (IV) ICU admission less than 24 h.
(V) physician termination of physiotherapy; and (VI) fever with causes other than chest infection, (VII) severe electrolyte imbalance, acute venous thromboembolism without therapeutic anticoagulation for over 48 h, (VIII) Unstable Atrial fibrillation, or severe tachycardia compared to baseline.
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 (Outcomes Assessor)
盲法说明
Data analyzer
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The eligibility criteria were as follows:
- •Patients aged from 45 to 60 years old.
- •Diagnosed by CT or PCR as positive COVID
- •Moderate cases of COVID-19(According to CO-RADS Scale).
- •On low flow rate oxygen supply
排除标准
- •Patients on Invasive Mechanical Ventilation
- •Hemodynamically Unstable with inotropic support
- •Septic Shock
- •ICU admission less than 24 h
- •physician termination of physiotherapy;
- •Fever with causes other than chest infection.
- •Severe electrolyte imbalance
- •Acute Venous Thromboembolism (VTE) without therapeutic anticoagulation for over 48 hours,
- •Unstable Atrial fibrillation , or Severe Tachycardia compared to baseline.
研究组 & 干预措施
Photobiomodulation therapy
Photobiomodulation therapy :Red laser wavelength (630-660 nm), Average power: 50-100 Mw, Dose: 6-10 J/cm2• Area 2-3 minutes/cm2, Sessions: twice -daily, acupuncture Laser Positions: transcutaneous laser therapy
干预措施: Photobiomodulation (Radiation)
Photobiomodulation therapy
Photobiomodulation therapy :Red laser wavelength (630-660 nm), Average power: 50-100 Mw, Dose: 6-10 J/cm2• Area 2-3 minutes/cm2, Sessions: twice -daily, acupuncture Laser Positions: transcutaneous laser therapy
干预措施: telerehabilitation (Other)
Myofascial release therapy
Myofascial release therapy A- Suboccipital release technique B- anterior cervical myofascial release C- Anterior thoracic and sternal myofascial release D- diaphragmatic dome release technique in addition to traditional physical therapy program
干预措施: Myofascial release therapy (Procedure)
Myofascial release therapy
Myofascial release therapy A- Suboccipital release technique B- anterior cervical myofascial release C- Anterior thoracic and sternal myofascial release D- diaphragmatic dome release technique in addition to traditional physical therapy program
干预措施: telerehabilitation (Other)
traditional physical therapy program
included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles )
干预措施: traditional chest physiotherapy (Device)
traditional physical therapy program
included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles )
干预措施: telerehabilitation (Other)
结局指标
主要结局
Lab Investigations
时间窗: at baseline and at discharge from ICU up to 14 days and at 3 month of discharge
(1) ferritin
lab investigation
时间窗: at baseline and at icu discharge up to 14 days and at 3 months of discharge
2\. D-dimer
次要结局
- lab analysis(at baseline and at ICU discharge up to 14 days and at 3 months of discharge)
- lab analysis(at baseline and at icu discharge up to 14 days and at 3 months of discharge)
- Maximum inspiratory pressure(at baseline and at icu discharge upto 14 days and at 3 months of discharge)
- Six-minute walk test(at baseline and at ICU discharge up to 14 days and at 3 months of discharge)
- Ease of breathing(at baseline and at ICU discharge up to 14 days and at 3 months of discharge)
- Dyspnea perception(at baseline and at ICU discharge, up to 14 days and at 3 months of discharge)
- Percentage of oxygen saturation(at baseline and at ICU discharge up to 14 days and at 3 months of discharge)
- Icu length of stay(at ICU discharge up to 2weeks)
- fatigue(at baseline and at ICU discharge up to 14 days and at 3 months of discharge)
- Lower limbs strength(at baseline and at ICU discharge upto 14 days and at 3 months of discharge)
研究者
Sherin Hassan Mohammed Mehani
Professor at Faculty of Physical Therapy - Beni-Suef University
Beni-Suef University