COVID-19 Hyper Coagulability Care by LLLT

NCT ID: NCT05271461

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-06-04

Brief Summary

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COVID-19 clotting Safety

Detailed Description

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

Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
circulatory exercise only, circulatory exercises and LLLT.

Study Groups

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Circulatory exercises group .

Circulatory exercises.

Group Type ACTIVE_COMPARATOR

Circulatory exercises

Intervention Type OTHER

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.

LLLT group .

Low level laser Therapy + circulatory exercises.

Group Type EXPERIMENTAL

Low level laser Therapy

Intervention Type RADIATION

Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.

Circulatory exercises

Intervention Type OTHER

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.

Interventions

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Low level laser Therapy

Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.

Intervention Type RADIATION

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Enas Wagdy Elsaid Ahmed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enas Dr Ahmed, BSC

Role: PRINCIPAL_INVESTIGATOR

Physical therapy faculty CairoU.

Locations

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Physical therapy faculty

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Enas Dr Ahmed, BSC

Role: CONTACT

01028406164 ext. Therapist

Facility Contacts

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Enas Dr Ahmed, Bsc

Role: primary

01028406164 ext. Therapist

Bsc

Role: backup

01028406164 ext. Therapist

References

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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.

Reference Type BACKGROUND
PMID: 10805940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32232218 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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COVID-19 LLLT.

Identifier Type: -

Identifier Source: org_study_id

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