NCT05094726

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 23, 2021

Last Update Submit

October 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

the participant will received photobiomodulation session.

Radiation: photobiomodulation

Group B

PLACEBO COMPARATOR

the participant will received placebo photobiomodulation session.

Other: placebo intervention by photobiomodulation device

Interventions

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 A

placebo intervention while the photobiomodulation device is on the off mode

Group B

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Agouza Outpatient Clinic

Giza, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Rana H El Banna, PHD

    Faculty of physical therapy at Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana H El Banna, PHD

CONTACT

Sherif O Elabd, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at faculty of physical therapy at Cairo University

Study Record Dates

First Submitted

October 23, 2021

First Posted

October 26, 2021

Study Start

September 8, 2021

Primary Completion

October 30, 2021

Study Completion

November 15, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations