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

Study Overview
=================
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.

Official Title
-----------------
A Comparative Study Between Photobiomodulation and Placebo on Functional Capacity and Fatigability in Post Covid-19 Elderly

Conditions
-----------------
Post Covid-19 Elderly

Intervention / Treatment
-----------------
* Radiation: photobiomodulation
* Other: placebo intervention by photobiomodulation device


Participation Criteria
=================
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 )

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>the participant will received photobiomodulation session. | Radiation: photobiomodulation<br>* 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.<br>|
| Placebo Comparator: Group B<br>the participant will received placebo photobiomodulation session. | Other: placebo intervention by photobiomodulation device<br>* placebo intervention while the photobiomodulation device is on the off mode<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of photobiomodulation on fatigability level | fatigability level will be assessed using fatigability assesment scale | after one month of the trial application | 
| effect of photobiomodulation on functional capacity level | functional capacity state will be assessed using submaximal exercise test (time up and go test) | after one month of the trial application |