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Completed

NCT Number: NCT06795841

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

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.

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Key information

Conditions

COVID 19 Disease COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy , Beni-Suef University

Banī Suwayf, 62511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The eligibility criteria were as follows:
  • Patients aged from 45 to 60 years old.
  • Diagnosed by CT or PCR as positive COVID 19.
  • Moderate cases of COVID-19(According to CO-RADS Scale).
  • On low flow rate oxygen supply

Exclusion criteria

  • 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.

Treatment and study plan

Photobiomodulation

Radiation

It 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

Myofascial release therapy

Procedure

technique was applied from supine position, with both hands cupping both diaphragmatic domes

traditional chest physiotherapy

Device

included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise

telerehabilitation

Other

Following 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

Primary outcomes

  1. Lab Investigations

    Time frame: at baseline and at discharge from ICU up to 14 days and at 3 month of discharge

    (1) ferritin

  2. lab investigation

    Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge

    • D-dimer

Secondary outcomes

  1. lab analysis

    Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge

    (3) CRP

  2. lab analysis

    Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge

    (4) Interleukin-6

  3. lab analysis

    Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge

    (5) white blood cell counts.

  4. Maximum inspiratory pressure

    Time frame: at baseline and at icu discharge upto 14 days and at 3 months of discharge

    Maximum inspiratory pressure

  5. Six-minute walk test

    Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge

    The 6-minute walk test (6-MWT) was conducted in the intensive care unit under the supervision

  6. Ease of breathing

    Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge

    It was assessed using visual analogue scale: Zero represented deep, comfortable breathing; 10 represented inability to breathe deeply. Scores were recorded on a graduated ruler

  7. Dyspnea perception

    Time frame: at baseline and at ICU discharge, up to 14 days and at 3 months of discharge

    It was assessed during a six-minute walking test: modified Borg scale (0-10) assessed dyspnea: zero = no dyspnea; 10 = maximum dyspnea ever experienced

  8. Percentage of oxygen saturation

    Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge

    portable intra-hospital patient monitor measured hemoglobin oxygen saturation in arterial blood.

  9. Icu length of stay

    Time frame: at ICU discharge up to 2weeks

  10. fatigue

    Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge

    The Fatigue Severity Scale:Nine-item scale with 7-point Likert responses (1=strongly disagree to 7=strongly agree). Total score represents arithmetic mean of item responses.

  11. Lower limbs strength

    Time frame: at baseline and at ICU discharge upto 14 days and at 3 months of discharge

    Quadriceps strength

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: PBM in COVID19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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