COVID-19 Hyper Coagulability Care by LLLT

COVID-19 Pneumonia Clinical Trial

— LLLT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271461
• Other study ID #: COVID-19 LLLT.
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 4, 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Enas Dr Ahmed, BSC
• Phone: 01028406164
• Email: enaswagdydaib[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

COVID-19 clotting Safety

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Thrombophilia

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Physical therapy faculty	Dokki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulatory group laboratory investigation.	D-dimer=.5mg/dL, fibrinogen>2.5mg/dL; To examine COVID-19 recovery.	Monthly (an average of two months)
Primary	Circulatory group: CBC analysis.	Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.	Daily (an average of two months)
Primary	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)
Primary	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)
Primary	Circulatory group. BMI.	weight kg on height m2 to detect liability for DVT.	Day one
Primary	Especially Lab investigation.	C-reactive protein =10mg/l for diagnosis of the recovery.	Baseline
Secondary	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)
Secondary	LLLT group CBC analysis.	lymphocyte count<1,500mm3, platelet count<150,000mm3, for examine COVID-19 recovery.	Daily (an average of two months)
Secondary	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)
Secondary	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)
Secondary	LLLT group. BMI.	Weight kg/height m2 to detect liability for DVT.	Day one
Secondary	Specifically Lab investigation.	C_reactive protein=10mg/l.help diagnosis of the recovery.	Baseline