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Effect of PBM on Functional Capacity and Fatigability in Post Covid-19 Elderly

NCT ID: NCT05094726

Last Updated: 2021-10-26

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2021-11-15

Brief Summary

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Participants had randomly divided into two equal groups. Group (A) which is the study group will receive photobiomodulation session two times per week for four weeks. Group (B) will be the control group that will receive placebo photobiomodulation two times per week for four weeks.

Detailed Description

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group (A):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

r group (B):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

Conditions

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Post Covid-19 Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
participants

Study Groups

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Group A

the participant will received photobiomodulation session.

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type RADIATION

Photobiomodulation (PBM) describes the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying.

Group B

the participant will received placebo photobiomodulation session.

Group Type PLACEBO_COMPARATOR

placebo intervention by photobiomodulation device

Intervention Type OTHER

placebo intervention while the photobiomodulation device is on the off mode

Interventions

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photobiomodulation

Photobiomodulation (PBM) describes the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying.

Intervention Type RADIATION

placebo intervention by photobiomodulation device

placebo intervention while the photobiomodulation device is on the off mode

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 to 75 years of age
* past history of covid 19 in the last year

Exclusion Criteria

* ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 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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Rana Elbanna

lecturer at faculty of physical therapy at Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rana H El Banna, PHD

Role: PRINCIPAL_INVESTIGATOR

Faculty of physical therapy at Cairo University

Locations

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Al Agouza Outpatient Clinic

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rana H El Banna, PHD

Role: CONTACT

Phone: 00201062070686

Email: [email protected]

Sherif O Elabd, master

Role: CONTACT

Phone: 002001067227404

Email: [email protected]

Facility Contacts

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sherif O osama, PHD

Role: primary

Other Identifiers

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Rana H Elbanna

Identifier Type: -

Identifier Source: org_study_id