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COVID-19 Hyper Coagulability Care by LLLT (LLLT)

Primary Purpose

COVID-19 Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low level laser Therapy
Circulatory exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Pneumonia

Eligibility Criteria

35 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physical therapy facultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Circulatory exercises group .

LLLT group .

Arm Description

Circulatory exercises.

Low level laser Therapy + circulatory exercises.

Outcomes

Primary Outcome Measures

Circulatory group laboratory investigation.
D-dimer≥.5mg/dL, fibrinogen>2.5mg/dL To examine COVID-19 recovery.
Circulatory group: CBC analysis.
Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.
Circulatory group (PT, PTT).
Prothrombin time>3 sec, activated partial thromboplastin time>5 sec to examine COVID-19 recovery.
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.
Circulatory group. BMI.
weight kg on height m2 to detect liability for DVT.
Especially Lab investigation.
C-reactive protein ≥10mg/l for diagnosis of the recovery.

Secondary Outcome Measures

LLLT group laboratory investigation.
D-dimer≥,5mg/dl, fibrinogen>2.5mg/dl, c-reactive protein≥10mg/dl to examine COVID-19 recovery. Fibrinogen
LLLT group CBC analysis.
lymphocyte count<1,500mm3, platelet count<150,000mm3, for examine COVID-19 recovery.
LLLT group. {PTT, PT}.
Prothrombin time>3 sec, activated partial thromboplastin time>5sec to examine COVID-19 recovery.
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.
LLLT group. BMI.
Weight kg/height m2 to detect liability for DVT.
Specifically Lab investigation.
C_reactive protein≥10mg/l.help diagnosis of the recovery.

Full Information

First Posted
February 14, 2022
Last Updated
March 8, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05271461
Brief Title
COVID-19 Hyper Coagulability Care by LLLT
Acronym
LLLT
Official Title
Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 4, 2022 (Anticipated)
Study Completion Date
June 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
COVID-19 clotting Safety
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.
Masking
Care Provider
Masking Description
circulatory exercise only, circulatory exercises and LLLT.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circulatory exercises group .
Arm Type
Active Comparator
Arm Description
Circulatory exercises.
Arm Title
LLLT group .
Arm Type
Experimental
Arm Description
Low level laser Therapy + circulatory exercises.
Intervention Type
Radiation
Intervention Name(s)
Low level laser Therapy
Intervention Description
Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.
Intervention Type
Other
Intervention Name(s)
Circulatory exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Circulatory group laboratory investigation.
Description
D-dimer≥.5mg/dL, fibrinogen>2.5mg/dL To examine COVID-19 recovery.
Time Frame
Monthly (an average of two months)
Title
Circulatory group: CBC analysis.
Description
Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.
Time Frame
Daily (an average of two months)
Title
Circulatory group (PT, PTT).
Description
Prothrombin time>3 sec, activated partial thromboplastin time>5 sec to examine COVID-19 recovery.
Time Frame
Bi weekly (an average of two months)
Title
Circulatory group physical examination.
Description
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.
Time Frame
Every two days (an average of two months)
Title
Circulatory group. BMI.
Description
weight kg on height m2 to detect liability for DVT.
Time Frame
Day one
Title
Especially Lab investigation.
Description
C-reactive protein ≥10mg/l for diagnosis of the recovery.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
LLLT group laboratory investigation.
Description
D-dimer≥,5mg/dl, fibrinogen>2.5mg/dl, c-reactive protein≥10mg/dl to examine COVID-19 recovery. Fibrinogen
Time Frame
Monthly (an average of two months)
Title
LLLT group CBC analysis.
Description
lymphocyte count<1,500mm3, platelet count<150,000mm3, for examine COVID-19 recovery.
Time Frame
Daily (an average of two months)
Title
LLLT group. {PTT, PT}.
Description
Prothrombin time>3 sec, activated partial thromboplastin time>5sec to examine COVID-19 recovery.
Time Frame
Bi weekly (an average of two months)
Title
LLLT group physical examination.
Description
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.
Time Frame
Every two days (an average of two months)
Title
LLLT group. BMI.
Description
Weight kg/height m2 to detect liability for DVT.
Time Frame
Day one
Title
Specifically Lab investigation.
Description
C_reactive protein≥10mg/l.help diagnosis of the recovery.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enas Dr Ahmed, BSC
Phone
01028406164
Ext
Therapist
Email
enaswagdydaib@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas Dr Ahmed, BSC
Organizational Affiliation
Physical therapy faculty CairoU.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical therapy faculty
City
Dokki
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enas Dr Ahmed, Bsc
Phone
01028406164
Ext
Therapist
Email
enaswagdydaib@gmail.com
First Name & Middle Initial & Last Name & Degree
Bsc
Phone
01028406164
Ext
Therapist
Email
enaswagdydaib@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10805940
Citation
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.
Results Reference
background
PubMed Identifier
32232218
Citation
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.
Results Reference
background
Citation
ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.
Results Reference
background

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COVID-19 Hyper Coagulability Care by LLLT

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