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CompletedNCT06795841

Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With COVID-19 With Follow-Up Telerehabilitation

Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With Moderate COVID 19 Inside Intensive Care Unit, With a Complementary Home Telerehabilitation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Beni-Suef University · Academic / Other
Sex
All
Age
45 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
RADIATIONPhotobiomodulationIt was applied for upper respiratory tract over tonsils, trachea, and main bronchi (bilaterally parasternal at the level of angle of Lewis), upper and lower lung, and at cubital vein
PROCEDUREMyofascial release therapytechnique was applied from supine position, with both hands cupping both diaphragmatic domes
DEVICEtraditional chest physiotherapyincluded traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise
OTHERtelerehabilitationFollowing ICU discharge, all patients participated in a 12-week structured home multidimensional telerehabilitation program delivered via videoconferencing (Zoom or Microsoft Teams) under the remote supervision of a physiotherapist. Sessions were conducted three times per week and incorporated patient education, breathing exercises, inspiratory muscle training (30 -50% MIP), strengthening of upper and lower limb muscle groups (50- 70 % 1RM), aerobic training (40- 60% HRR), and trunk control activities. Safety monitoring was emphasized throughout, with patients instructed to use a pulse oximeter before, during, and after each session. Adherence was assessed by session attendance, exercise diaries, and weekly therapist follow-up

Timeline

Start date
2020-06-01
Primary completion
2020-12-15
Completion
2020-12-31
First posted
2025-01-28
Last updated
2026-01-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06795841. Inclusion in this directory is not an endorsement.