Photobiomodulation TherapyNCT06252467
Photobiomodulation Therapy on Performance in Successive Cycling Tests
A study testing Photobiomodulation Therapy in people with Photobiomodulation Therapy and Cyclists, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
Trial summary
The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. This was a double blind, randomized, crossover, placebo-controlled trial study. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Photobiomodulation Therapy, Cyclists, Performance
- What is being tested?
- Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jul 2014to 11 Oct 2023
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cyclists aged 18-30 years;
- Competitive history;
- No history of musculoskeletal injuries in the lower limbs in the last two years.
Who cannot join
- Chronic disease;
- Smoking;
- Metabolic disorders;
- Use of steroids in the last six months;
- Physical disabilities;
- Use of antibiotic drugs in the previous week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photobiomodulation Therapy on Performance in Successive Time-to-Exhaustion Cycling Tests: A Randomized Double-Blinded Placebo Controlled Trial
The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. This was a double blind, randomized, crossover, placebo-controlled trial study. Sixteen cyclists (~23 years old), with a cycling training volume of ~460 km/week, volunteered for this study. In the first session, cyclists performed a maximal incremental test to determine maximal oxygen uptake and maximal power output (POMAX). In the following sessions, cyclists performed three consecutive TTEs at POMAX. Before each test, PBMT (135 J/thigh) or a placebo (PLA) PBMT was applied to both thighs. VO2 amplitude, O2 deficit, time delay, oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and total hemoglobin (tHb) were measured during tests on the right vastus lateralis. The PBMT, applied before three successive TTE, increased performance of the first and second TTE (~10-12%) tests, speed of VO2 and HHb kinetics during the first test, and increased peripheral muscle oxygenation (increase in HHb and tHb) in the first and second exhaustion tests. However, the PBMT effects were attenuated in the third TTE, as performance and all the other outcomes were similar to the ones from the PLA intervention. In summary, PBMT application increased the first and second successive TTEs, speed of VO2, and muscle oxygenation.
Read the detailed description
The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. Our study was characterized as a crossover, randomized, double-blind trial (blinding of the cyclists and the researcher responsible for evaluations). All protocols were explained to the participants, who voluntarily provided their consent to participate in the investigation through an informed consent document. This study received approval from the Research Ethics Committee for Human Subjects Studies at the institution where the research was conducted (number 708.362). Inclusion criteria involved cyclists aged 18-30 years, with a competitive history and no history of musculoskeletal injuries in the lower limbs in the last two years. Exclusion criteria included chronic disease, smoking, metabolic disorders, use of steroids in the last six months, chronic disease, physical disabilities, and use of antibiotic drugs in the previous week. The cyclists participating in the present study had ~6.5 years of regular training/competition and no history of lower limb muscular and/or skeletal injuries. Each cyclist visited the laboratory on three occasions. At the first visit, cyclists performed a maximum incremental test and familiarization to three successive TTEs. At the two subsequent visits, participants performed a standard protocol of three successive TTEs at maximal power output (POMAX) with preferred cadence, and PBMT or placebo (PLA) treatments were applied before each trial. The three testing days were performed with a 72h interval apart. A single therapist was involved with the random allocation of the PBMT and PLA interventions. This therapist received instructions not to disclose the treatment modality employed during each assessment session to either the cyclists or other researchers involved with data collection and data analysis. Furthermore, cyclists utilized opaque eyewear to shield their eyes and obstruct their visual access (visual blinding) during the PBMT or PLA intervention. The therapist was explicitly advised against revealing the treatment modality to both the cyclists and the other researchers. PBMT did not elicit any thermal or tactile sensations, thereby ensuring that athletes remained unaware of the specific application on their thigh area. The random assignment was determined through a basic drawing of lots during the first testing session, determining the allocation of either active PBMT or inactive PLA.
- Conditions
- Photobiomodulation Therapy, Cyclists, Performance
- Being tested
- Photobiomodulation Therapy, Placebo Photobiomodulation
- Keywords
- Phototherapy, VO2 response, muscle oxygenation, cyclists, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyDevice
Phototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle
. A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study.
Placebo PhotobiomodulationDevice
The placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Device: Active Photobiomodulation Therapy Phototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle
. A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study. Receives: Device: Photobiomodulation Therapy |
| Placebo Comparator | Placebo comparator | Device: Placebo Photobiomodulation The placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test. Receives: Device: Placebo Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycling performance
Cyclists performed the three successive time-to-exhaustion at maximal power output at their preferred cadence. Exhaustion was defined as the time when the cyclist was unable to maintain a cadence above 70 rotations per minute. During the successive time-to-exhaustion, cadence and power output were measured using the cycle ergometer software (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands). The cyclists' evaluation was conducted utilizing a cycle ergometer (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands) configured to match their bike's handlebar and seat settings.
Measured: Cyclits performed a standard protocol of three successive tests to exhaustion at maximal power output with preferred cadence, and photobiomodulation therapy or placebo treatments were applied before each trial. The three testing days were performed
Oxygen uptake
Oxygen uptake was measured breath-by-breath using an open-circuit gas analyzer (Quark CPET, Cosmed, Rome, Lazio, Italy). Oxygen uptake measurements were plotted to facilitate the exclusion of values lying beyond four standard deviations above or below the average of the dynamic window (three breaths), taken as the reference for the overall curve average. Analysis of oxygen uptake kinetics during successive time-to-exhaustion was converted into 5 seconds windows, and mean values were calculated. The analysis of oxygen uptake kinetics was dependent on the duration of the three time-to-exhaustion for each athlete in each condition (Photobiomodulation therapy or placebo). Oxygen uptake kinetics were calculated with the nonlinear least-squares method implemented in MATLAB (Mathworks, Natick, MA, USA) to adjust the oxygen uptake data.
Measured: Oxygen uptake response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Secondary outcomes (1)
Periphery muscle oxygenation
Peripheral muscle oxygenation data collection was performed using a NIRS (PortaMon, Artinis Medical Systems, Elst, Guéldria, Netherlands) probe (light emitting and photoreceptor), which was positioned in the vastus lateralis muscle belly of the right lower limb, longitudinally located between the femur's lateral epicondyle and trochanter, fixed with adhesive tape (3M Company, Saint Paul, MN, USA), and wrapped by the cyclist's bretelle to prevent light penetration during all time-to-exhaustion. Data from the NIRS system were analyzed from average windows every 20% of the time-to-exhaustion tests and retests. The oxyhemoglobin, deoxyhemoglobin, and total hemoglobin were evaluated. Furthermore, oxyhemoglobin, deoxyhemoglobin, and total hemoglobin values were normalized by their respective mean values obtained at rest before the first time-to-exhaustion in each condition, which were used to compare the experimental situations (Phobiomodulation Therapy or Placebo).
Measured: Periphery muscle oxygenation response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start14 Jul 2014
- Primary completion23 May 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photobiomodulation TherapyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Crossover, randomized, double-blind trial (blinding of the cyclists and the researcher responsible for evaluations)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Aurélio Vaz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252467
- Sponsor's protocol ID
- 708.362
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy on Performance in Successive Time-to-Exhaustion Cycling Tests: A Randomized Double-Blinded Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06252467
- Acronym / sponsor ID
- 708.362
- Conditions
- Photobiomodulation Therapy, Cyclists, Performance
- Keywords
- Phototherapy, VO2 response, muscle oxygenation, cyclists, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Marco Aurélio Vaz, PhDUniversity, hospital or other
- Study start
- 14 Jul 2014 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 9 Feb 2024 (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.
The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. This was a double blind, randomized, crossover, placebo-controlled trial study. Sixteen cyclists (~23 years old), with a cycling training volume of ~460 km/week, volunteered for this study. In the first session, cyclists performed a maximal incremental test to determine maximal oxygen uptake and maximal power output (POMAX). In the following sessions, cyclists performed three consecutive TTEs at POMAX. Before each test, PBMT (135 J/thigh) or a placebo (PLA) PBMT was applied to both thighs. VO2 amplitude, O2 deficit, time delay, oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and total hemoglobin (tHb) were measured during tests on the right vastus lateralis. The PBMT, applied before three successive TTE, increased performance of the first and second TTE (~10-12%) tests, speed of VO2 and HHb kinetics during the first test, and increased peripheral muscle oxygenation (increase in HHb and tHb) in the first and second exhaustion tests. However, the PBMT effects were attenuated in the third TTE, as performance and all the other outcomes were similar to the ones from the PLA intervention. In summary, PBMT application increased the first and second successive TTEs, speed of VO2, and muscle oxygenation.
Detailed description
The goal of this study was to investigate the effects of Photobiomodulation therapy (PBMT) on performance, oxygen uptake (VO2 kinetics), and lower limb muscle oxygenation during three successive time-to-exhaustion tests (TTEs) in cyclists. Our study was characterized as a crossover, randomized, double-blind trial (blinding of the cyclists and the researcher responsible for evaluations). All protocols were explained to the participants, who voluntarily provided their consent to participate in the investigation through an informed consent document. This study received approval from the Research Ethics Committee for Human Subjects Studies at the institution where the research was conducted (number 708.362). Inclusion criteria involved cyclists aged 18-30 years, with a competitive history and no history of musculoskeletal injuries in the lower limbs in the last two years. Exclusion criteria included chronic disease, smoking, metabolic disorders, use of steroids in the last six months, chronic disease, physical disabilities, and use of antibiotic drugs in the previous week. The cyclists participating in the present study had ~6.5 years of regular training/competition and no history of lower limb muscular and/or skeletal injuries. Each cyclist visited the laboratory on three occasions. At the first visit, cyclists performed a maximum incremental test and familiarization to three successive TTEs. At the two subsequent visits, participants performed a standard protocol of three successive TTEs at maximal power output (POMAX) with preferred cadence, and PBMT or placebo (PLA) treatments were applied before each trial. The three testing days were performed with a 72h interval apart. A single therapist was involved with the random allocation of the PBMT and PLA interventions. This therapist received instructions not to disclose the treatment modality employed during each assessment session to either the cyclists or other researchers involved with data collection and data analysis. Furthermore, cyclists utilized opaque eyewear to shield their eyes and obstruct their visual access (visual blinding) during the PBMT or PLA intervention. The therapist was explicitly advised against revealing the treatment modality to both the cyclists and the other researchers. PBMT did not elicit any thermal or tactile sensations, thereby ensuring that athletes remained unaware of the specific application on their thigh area. The random assignment was determined through a basic drawing of lots during the first testing session, determining the allocation of either active PBMT or inactive PLA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment Crossover, randomized, double-blind trial (blinding of the cyclists and the researcher responsible for evaluations)
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Device: Photobiomodulation TherapyDevice: Active Photobiomodulation Therapy Phototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle . A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study. |
| Placebo Comparator | Placebo comparator | Device: Placebo PhotobiomodulationDevice: Placebo Photobiomodulation The placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cyclists aged 18-30 years;
- Competitive history;
- No history of musculoskeletal injuries in the lower limbs in the last two years.
Key exclusion criteria (6 listed)
- Chronic disease;
- Smoking;
- Metabolic disorders;
- Use of steroids in the last six months;
- Physical disabilities;
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 |
|---|---|---|
| Photobiomodulation TherapyPhototherapy treatment (Photobiomodulation therapy or placebo) was performed using a Photobiomodulation therapy device (Vectra Genisys Systems, Chattanooga Group, Dallas, TX, USA). The cluster probe consisted of five low-level laser therapy diodes (850 nm) and 28 light emitting diodes therapy (670 nm, 880 nm, and 950 nm). Photobiomodulation therapy was applied in nine sites of each quadriceps femoris muscle . A dosage of 15 J per site led to a total energy of 135 J per thigh, effectively increasing cycling performance in a previous study. We chose to apply Photobiomodulation therapy specifically to the quadriceps femoris because this muscle group is of utmost significance in generating torque and propelling the pedaling cycle. Its pivotal role in cycling performance made this muscle a prime target for the Photobiomodulation therapy intervention in our study. | Device | Active Comparator |
| Placebo PhotobiomodulationThe placebo treatment was performed in exactly the same manner as the Photobiomodulation therapy treatment, but with the device switched off, and the cluster was held stationary in contact with the skin at a 90° angle, with light pressure on the skin. The total application time of Photobiomodulation therapy or placebo was ~5 min for both limbs (9 points per thigh = 18 points × 16 s per point) before each time-to-exhaustion test. | Device | Placebo Comparator |
Primary outcome
Cycling performance
Time frame: Cyclits performed a standard protocol of three successive tests to exhaustion at maximal power output with preferred cadence, and photobiomodulation therapy or placebo treatments were applied before each trial. The three testing days were performed
Cyclists performed the three successive time-to-exhaustion at maximal power output at their preferred cadence. Exhaustion was defined as the time when the cyclist was unable to maintain a cadence above 70 rotations per minute. During the successive time-to-exhaustion, cadence and power output were measured using the cycle ergometer software (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands). The cyclists' evaluation was conducted utilizing a cycle ergometer (Excalibur Sport, Lode Medical Technology, Groningen, Groninga, The Netherlands) configured to match their bike's handlebar and seat settings.
Oxygen uptake
Time frame: Oxygen uptake response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Oxygen uptake was measured breath-by-breath using an open-circuit gas analyzer (Quark CPET, Cosmed, Rome, Lazio, Italy). Oxygen uptake measurements were plotted to facilitate the exclusion of values lying beyond four standard deviations above or below the average of the dynamic window (three breaths), taken as the reference for the overall curve average. Analysis of oxygen uptake kinetics during successive time-to-exhaustion was converted into 5 seconds windows, and mean values were calculated. The analysis of oxygen uptake kinetics was dependent on the duration of the three time-to-exhaustion for each athlete in each condition (Photobiomodulation therapy or placebo). Oxygen uptake kinetics were calculated with the nonlinear least-squares method implemented in MATLAB (Mathworks, Natick, MA, USA) to adjust the oxygen uptake data.
1 secondary outcome
Periphery muscle oxygenation
Time frame: Periphery muscle oxygenation response was measured during the three sucessive time-to-exhaustion in two days (Photobiomodulation Therapy or Placebo) with a 72 hours interval apart.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Therapy in people with Photobiomodulation Therapy and Cyclists, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Feb 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycling performance (time frame: Cyclits performed a standard protocol of three successive tests to exhaustion at maximal power output with preferred cadence, and photobiomodulation therapy or placebo treatments were applied before each trial. The three testing days were performed). 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 9 Feb 2024.