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

October 23, 2021 updated by: Rana Elbanna, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Recruiting
        • Al Agouza Outpatient Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Rana H El Banna, PHD, Faculty of physical therapy at Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

November 15, 2021

Study Registration Dates

First Submitted

October 23, 2021

First Submitted That Met QC Criteria

October 23, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 23, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rana H Elbanna

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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