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

Primary Purpose

Post Covid-19 Elderly

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
photobiomodulation
placebo intervention by photobiomodulation device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Covid-19 Elderly

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 )

Sites / Locations

  • Al Agouza Outpatient ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

the participant will received photobiomodulation session.

the participant will received placebo photobiomodulation session.

Outcomes

Primary Outcome Measures

effect of photobiomodulation on fatigability level
fatigability level will be assessed using fatigability assesment scale
effect of photobiomodulation on functional capacity level
functional capacity state will be assessed using submaximal exercise test (time up and go test)

Secondary Outcome Measures

Full Information

First Posted
October 23, 2021
Last Updated
October 23, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05094726
Brief Title
Effect of PBM on Functional Capacity and Fatigability in Post Covid-19 Elderly
Official Title
A Comparative Study Between Photobiomodulation and Placebo on Functional Capacity and Fatigability in Post Covid-19 Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (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

5. Study Description

Brief Summary
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
group (A): Each participant will sign a consent form after receiving a detailed explanation about the procedure. submaximal exercise capacity using time up and go test will be assessed. fatigability will be assessed using fatigue assessment scale. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed. After one month all the assessment procedure will be repeated again. r group (B): Each participant will sign a consent form after receiving a detailed explanation about the procedure. submaximal exercise capacity using time up and go test will be assessed. fatigability will be assessed using fatigue assessment scale. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed. After one month all the assessment procedure will be repeated again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Covid-19 Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
Masking
Participant
Masking Description
participants
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
the participant will received photobiomodulation session.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
the participant will received placebo photobiomodulation session.
Intervention Type
Radiation
Intervention Name(s)
photobiomodulation
Intervention Description
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
Other
Intervention Name(s)
placebo intervention by photobiomodulation device
Intervention Description
placebo intervention while the photobiomodulation device is on the off mode
Primary Outcome Measure Information:
Title
effect of photobiomodulation on fatigability level
Description
fatigability level will be assessed using fatigability assesment scale
Time Frame
after one month of the trial application
Title
effect of photobiomodulation on functional capacity level
Description
functional capacity state will be assessed using submaximal exercise test (time up and go test)
Time Frame
after one month of the trial application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana H El Banna, PHD
Phone
00201062070686
Email
rana.elbanna@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif O Elabd, master
Phone
002001067227404
Email
shiref.osama@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana H El Banna, PHD
Organizational Affiliation
Faculty of physical therapy at Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Agouza Outpatient Clinic
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sherif O osama, PHD
Phone
00201067227404
Email
shiref.elabd@yahoo.com

12. IPD Sharing Statement

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

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