COVID-19 Hyper Coagulability Care by LLLT (LLLT)

Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19

COVID-19 clotting Safety

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Other: Circulatory exercises; Radiation: Low level laser Therapy

Detailed Description

Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enas Dr Ahmed, Bsc; Phone Number: Therapist 01028406164; Email: enaswagdydaib@gmail.com

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12611
      • Recruiting
      • Physical therapy faculty
      • Contact: Enas Dr Ahmed, Bsc; Phone Number: Therapist 01028406164; Email: enaswagdydaib@gmail.com
      • Contact: Bsc; Phone Number: Therapist 01028406164; Email: enaswagdydaib@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI from 18.5 to 29.9 kg/m2
• Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:
• Nasopharyngeal swab
• Sepsis induced coagulopathy score>4
• D_dimer≥0,5mg/L
• Fibrinogen>2,5gm/L
• C_reactive protein≥10mg/L
• Lymphocyte count<1,500mm3
• Platelet count<150,000mm3
• Prothrombin time increase>3sec
• Activated partial thromboplastin time increase>5sec
• Same level of physical activity
• Patients can swallow tablets
• CT scan screening method for COVID-19 Diagnosis
• Physical examination

Exclusion Criteria:

• hyper tension
• Cognitive impairment e.g (delirium)
• Diabetes mellitus both types dependant or non
• Disabled musculoskeletal Disorders e.g hemi paresis
• Coronary artery diseases and heart failure
• DVT
• Stroke, bone disease, renal failure, pulmonary embolism
• Vitamins deficiency
• 6 months post large surgeries
• Alcohol intake and smokers
• Thyroid diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Circulatory exercises group .; Circulatory exercises.	Other: Circulatory exercises; Active assisted or against mild resistance. Supine with leg up position 18degrees measured by the bed water balance in side rails. If patient is not comfortable according to the modified Borg scale or contra indicated for the position then assume the supine position. The subject will have A 3 min rest period to acclimatize themselves to each position. The ankle pumping exercises consisted of simple repetitions of dorsiflexion 1 sec and planter- flexion for 1 sec with three different exercise intervals: repeated dorsiflexion and planter-flexion with no rest (no rest exercise).; repeated dorsiflexion and planter-flexion with a 2 sec rest period (2 sec rest exercise).; repeated dorsiflexion and planter-flexion with 4sec rest period (4sec rest exercise). Subjects will have practiced ankle pumps before the exercise to get familiar and be educated about the procedure.
EXPERIMENTAL: LLLT group .; Low level laser Therapy + circulatory exercises.	Other: Circulatory exercises; Active assisted or against mild resistance. Supine with leg up position 18degrees measured by the bed water balance in side rails. If patient is not comfortable according to the modified Borg scale or contra indicated for the position then assume the supine position. The subject will have A 3 min rest period to acclimatize themselves to each position. The ankle pumping exercises consisted of simple repetitions of dorsiflexion 1 sec and planter- flexion for 1 sec with three different exercise intervals: repeated dorsiflexion and planter-flexion with no rest (no rest exercise).; repeated dorsiflexion and planter-flexion with a 2 sec rest period (2 sec rest exercise).; repeated dorsiflexion and planter-flexion with 4sec rest period (4sec rest exercise). Subjects will have practiced ankle pumps before the exercise to get familiar and be educated about the procedure.; Radiation: Low level laser Therapy; Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulatory group laboratory investigation.	D-dimer≥.5mg/dL, fibrinogen>2.5mg/dL To examine COVID-19 recovery.	Monthly (an average of two months)
Circulatory group: CBC analysis.	Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.	Daily (an average of two months)
Circulatory group (PT, PTT).	Prothrombin time>3 sec, activated partial thromboplastin time>5 sec to examine COVID-19 recovery.	Bi weekly (an average of two months)
Circulatory group physical examination.	by visual analog scale is horizontal line 100mm length the ends defined as extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) the right (the best) 3 times per week to detect DVT.	Every two days (an average of two months)
Circulatory group. BMI.	weight kg on height m2 to detect liability for DVT.	Day one
Especially Lab investigation.	C-reactive protein ≥10mg/l for diagnosis of the recovery.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LLLT group laboratory investigation.	D-dimer≥,5mg/dl, fibrinogen>2.5mg/dl, c-reactive protein≥10mg/dl to examine COVID-19 recovery. Fibrinogen	Monthly (an average of two months)
LLLT group CBC analysis.	lymphocyte count<1,500mm3, platelet count<150,000mm3, for examine COVID-19 recovery.	Daily (an average of two months)
LLLT group. {PTT, PT}.	Prothrombin time>3 sec, activated partial thromboplastin time>5sec to examine COVID-19 recovery.	Bi weekly (an average of two months)
LLLT group physical examination.	by visual analog scale is a straight horizontal line of fixed length 100mm the end is extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) to the right (the best) 3times per week to detect DVT.	Every two days (an average of two months)
LLLT group. BMI.	Weight kg/height m2 to detect liability for DVT.	Day one
Specifically Lab investigation.	C_reactive protein≥10mg/l.help diagnosis of the recovery.	Baseline

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Enas Dr Ahmed, BSC, Physical therapy faculty CairoU.

Publications and helpful links

General Publications

• Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of Underlying Diseases in Hospitalized Patients with COVID-19: a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.
• Agaiby AD, Ghali LR, Wilson R, Dyson M. Laser modulation of angiogenic factor production by T-lymphocytes. Lasers Surg Med. 2000;26(4):357-63. doi: 10.1002/(sici)1096-9101(2000)26:43.0.co;2-o.
• ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): April 4, 2022
• Study Completion (ANTICIPATED): June 4, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (ACTUAL): March 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; COVID-19; Thrombophilia
• Other Study ID Numbers: COVID-19 LLLT.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No