Post Covid-19 ElderlyNCT05094726
Effect of PBM on Functional Capacity and Fatigability in Post Covid-19 Elderly
A study testing photobiomodulation in people with Post Covid-19 Elderly, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Covid-19 Elderly
- What is being tested?
- photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2021to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 to 75 years of age
- past history of covid 19 in the last year
Who cannot join
- ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Agouza Outpatient Clinic
Giza, 12613
sherif O osama, PHD, 00201067227404, shiref.elabd@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Covid-19 Elderly
- Being tested
- photobiomodulation, placebo intervention by photobiomodulation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationRadiation
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 intervention by photobiomodulation deviceOther
placebo intervention while the photobiomodulation device is on the off mode
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | the participant will received photobiomodulation session. Receives: Radiation: photobiomodulation |
| Group B | Placebo comparator | the participant will received placebo photobiomodulation session. Receives: Other: placebo intervention by photobiomodulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of photobiomodulation on fatigability level
fatigability level will be assessed using fatigability assesment scale
Measured: 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)
Measured: after one month of the trial application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start8 Sep 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Covid-19 ElderlyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
- Investigators
- Rana H El Banna, PHD, Principal investigator, Faculty of physical therapy at Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094726
- Sponsor's protocol ID
- Rana H Elbanna
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Photobiomodulation and Placebo on Functional Capacity and Fatigability in Post Covid-19 Elderly
- ClinicalTrials.gov ID
- NCT05094726
- Acronym / sponsor ID
- Rana H Elbanna
- Conditions
- Post Covid-19 Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Radiation: photobiomodulationthe participant will received photobiomodulation session. |
| Group B | Placebo comparator | Other: placebo intervention by photobiomodulation devicethe participant will received placebo photobiomodulation session. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 to 75 years of age
- past history of covid 19 in the last year
Key exclusion criteria (1 listed)
- ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photobiomodulationPhotobiomodulation (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. | Radiation | Group A |
| placebo intervention by photobiomodulation deviceplacebo intervention while the photobiomodulation device is on the off mode | Other | Group B |
Primary outcome
effect of photobiomodulation on fatigability level
Time frame: after one month of the trial application
fatigability level will be assessed using fatigability assesment scale
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Related trials for Post Covid-19 Elderly
Active, not recruitingObservational study
Long COVID and Its Associations With Health Outcomes in Older Adults
Long COVID, COVID-19 Pandemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana H El Banna, PHD principal investigator
Faculty of physical therapy at Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation in people with Post Covid-19 Elderly, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana H El Banna, PHD (00201062070686, rana.elbanna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of photobiomodulation on fatigability level (time frame: after one month of the trial application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.