COVID-19ATHLOSNCT04368845
Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study
A study testing Telerehabilitation in people with COVID-19 and Comorbidities and Coexisting Conditions, run by University of Thessaly at 1 site in Greece.
Trial summary
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals, in order to offer telehealth services at home in patients with COVID-19, after hospital discharge. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- COVID-19, Comorbidities and Coexisting Conditions
- What is being tested?
- Telerehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2020to 31 Jul 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults with age from 20 to 65 years hospitalized due COVID-19 infection. Able to give consent
Who cannot join
- the presence of mental illness, any physical disability that makes difficult to mobilize patients, severe heart disease, severe musculoskeletal pain, vascular aneurysms, severe neurological condition, pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site
Clinical exercise Physiology and rehabilitation research laboratory
Lamia, 35100
About this study
Official title: A Telerehabilitation Approach to Improve Long-term Physical Ability and Quality of Life in Patients With Severe Acute Respiratory Syndrome Coronavirus (SARSCoV-2, COVID-19) Immediately After Hospitalization. The ATHLOS Study
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals, in order to offer telehealth services at home in patients with COVID-19, after hospital discharge.
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc).
At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults (aged 20-65 years) diagnosed with COVID-19, who completed the first phase of this study. At this phase, the study will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care. The intervention program includes individualized prescribed endurance exercises, low intensity aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.
Read the detailed description
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals in order to offer home telehealth services in patients with COVID-19, after hospital discharge.
At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc).
We aim to support 200 patients with age 20-65 years, between a 1-8 week period after hospital discharge, providing an e-book with body exercises, breathing exercises and nutritional support, additionally to four telehealth consultation sessions.
At the second phase, a single blinded randomized control trial study will evaluate a 6-month home telerehabilitation program for 100 diagnosed with COVID-19 adults (aged 20-65 years), who completed the first phase of this study. The second phase will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care.
The intervention includes individualized prescribed upper and lower extremity endurance exercises, aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.
The usual care group will be advised to follow the instructions of the e-book for any possible exercise training. Three times per month with 1:1 video conferencing, an expert physiotherapist will record any possible exercise with no further recommendations or support.
Changes from baseline in physical activity levels, cardiorespiratory fitness, physical performance, lower limb strength, anxiety and depression and health-related quality of life will be assessed at 3 and 6 months for both groups. All functional tests in the second phase of the study will be performed via supervision teleconference for all the participants with an expert physiotherapist. Findings from this project will contribute to the field of telerehabilitation in patients with COVID-19 after hospital discharge and will provide critical preliminary data for the design and implementation of a larger, randomized control trial assessing the impact of telerehabilitation on long-term clinical outcomes following infection or re-infection from coronaviruses.
- Conditions
- COVID-19, Comorbidities and Coexisting Conditions
- Being tested
- Telerehabilitation
- Keywords
- covid-19, telerehabilitation, physiotherapy, home rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
The treatment arm will be given up to 1-hour breathing exercises, aerobic and resistive training exercises administered by a physiotherapist via a telerehabilitation device every 10 days for a six-month period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention Arm: Telerehabilitation | Active comparator | The treatment arm will be given up to 1-hour resistive training exercises, breathing exercises and aerobic exercises administered by an expert physiotherapist via teleconference (telerehabilitation). Every ten days one physiotherapist will record the individualized exercise program, will reevaluate the magnitude of exercise for each patient and reinforce to continue or increase exercise magnitude. Receives: Device: Telerehabilitation |
| No Intervention: Conventional teleconference | No intervention | The usual care arm will receive standard communication via teleconference every ten days for a six-month period without any specific recommendations and exercise prescription for home training. The control arm will be subject to the same assessments as the experimental arm at the start, and at the 3 and 6 months period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Measured: Change From Baseline in SPPB Scores at 3 and 6 months
Cardiorespiratory fitness
The 3 minute step test (3MST) is a field test designed to measure aerobic (cardiovascular) fitness. Participants step up and down a 30-cm high step for 3 minutes at a pace of 24 steps per minute. Oxygen saturation, heart rate and fatigue (using the Borg 0-10 scale) will be assessed at the beginning, at the end and every minute after full recovery in order to evaluate the heart's, fatigue and saturation recovery rates. Because it is a submaximal test it can easily be completed at home and administrated via video conferencing.
Measured: Change From Baseline in 3MST Scores at 3 and 6 months
Lower limb Strength
The 30 sec sit-to-stand test (STST) is a feasible alternative for measuring lower limb muscle strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 seconds.
Measured: Change From Baseline in STST Scores at 3 and 6 months
Health Related Quality of Life
The Short Form Health Survey (SF-36) consists of 36 questions spanning 8 health (physical and mental) domains. The eight domains are: vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Converging the individual scores into z-score, a standardized score (mean 50) is provided for each domain allowing comparisons between populations. The lower the score the more disability. It is a valid patient-reported survey of health-related quality of life in patient populations and it is responsive to change following therapeutic interventions.
Measured: Change From Baseline in SF-36 Scores at 3 and 6 months
Anxiety and Depression
Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale
Measured: Change From Baseline in HADS Scores at 3 and 6 months
Physical Activity
The International Physical Activity Questionnaire (IPAQ) is a frequently used instrument for the evaluation of physical activity (PA). It was developed in order to assess physical activity in adults aged 18-65 years. The greek version of IPAQ, (IPAQ-Gr) sums up moderate, vigorous, walking physical activities over the previous seven-day period and generate a total physical activity score (PAscore), expressed in MET-minutes per week (MET.min.wk-1 ).
Based on the IPAQ scoring procedure, physical activity status is classified into three categories (PAclasses): (1) low PAclass, insufficiently active subjects (total PAscore < 600 MET.min.wk-1); (2) moderate PAclass (total PAscore ≥ 600 MET.min.wk-1 or vigorous PAscore ≥ 480 MET.min.wk-1) and (3) high PAclass (total PAscore ≥ 3000 MET.min.wk-1 or vigorous PAscore ≥ 1500 MET.min.wk-1).
Measured: Change From Baseline in IPAQ Scores at 3 and 6 months
Secondary outcomes (2)
Fatigue
The Borg CR-10 (CR= scale range) scale is a rating scale for self-reported dyspnea. 0 represents no symptoms and 10 the worst previously experienced symptoms.
Measured: Change From Baseline in Borg CR-10 Scores at 3 and 6 months
Dyspnea
The modified Medical Research Council Dyspnea Scale (MMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.
Measured: Change From Baseline in MMRC Scores at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Two arm single blinded randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens, University of Ioannina
- Responsible party
- Principal investigator, Eleni Kortianou, University of Thessaly
- Investigators
- ELENI KORTIANOU, PhD, PT, Study director, Clinical Exercise Physiology and Rehabilitation Research LaboratoryELENI KAPRELI, PhD, PT, Study chair, Clinical Exercise Physiology and Rehabilitation Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368845
- Sponsor's protocol ID
- 1
- Acronym
- ATHLOS
- Status last verified
- Jan 2022
- First submitted
- 20 Apr 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papathanasiou G, Georgoudis G, Papandreou M, Spyropoulos P, Georgakopoulos D, Kalfakakou V, Evangelou A. Reliability measures of the short International Physical Activity Questionnaire (IPAQ) in Greek young adults. Hellenic J Cardiol. 2009 Jul-Aug;50(4):283-94.
PubMed 19622498Bergland A, Strand BH. Norwegian reference values for the Short Physical Performance Battery (SPPB): the Tromso Study. BMC Geriatr. 2019 Aug 8;19(1):216. doi: 10.1186/s12877-019-1234-8.
PubMed 31395008Wassenberg MW, Severs D, Bonten MJ. Psychological impact of short-term isolation measures in hospitalised patients. J Hosp Infect. 2010 Jun;75(2):124-7. doi: 10.1016/j.jhin.2010.01.023. Epub 2010 Apr 10.
PubMed 20381912
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telerehabilitation Approach to Improve Long-term Physical Ability and Quality of Life in Patients With Severe Acute Respiratory Syndrome Coronavirus (SARSCoV-2, COVID-19) Immediately After Hospitalization. The ATHLOS Study
- ClinicalTrials.gov ID
- NCT04368845
- Acronym / sponsor ID
- ATHLOS / 1
- Conditions
- COVID-19, Comorbidities and Coexisting Conditions
- Keywords
- covid-19, telerehabilitation, physiotherapy, home rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Athens, University of Ioannina
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 30 Apr 2020 (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.
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals, in order to offer telehealth services at home in patients with COVID-19, after hospital discharge.
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc).
At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults (aged 20-65 years) diagnosed with COVID-19, who completed the first phase of this study. At this phase, the study will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care. The intervention program includes individualized prescribed endurance exercises, low intensity aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.
Detailed description
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals in order to offer home telehealth services in patients with COVID-19, after hospital discharge.
At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc).
We aim to support 200 patients with age 20-65 years, between a 1-8 week period after hospital discharge, providing an e-book with body exercises, breathing exercises and nutritional support, additionally to four telehealth consultation sessions.
At the second phase, a single blinded randomized control trial study will evaluate a 6-month home telerehabilitation program for 100 diagnosed with COVID-19 adults (aged 20-65 years), who completed the first phase of this study. The second phase will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care.
The intervention includes individualized prescribed upper and lower extremity endurance exercises, aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.
The usual care group will be advised to follow the instructions of the e-book for any possible exercise training. Three times per month with 1:1 video conferencing, an expert physiotherapist will record any possible exercise with no further recommendations or support.
Changes from baseline in physical activity levels, cardiorespiratory fitness, physical performance, lower limb strength, anxiety and depression and health-related quality of life will be assessed at 3 and 6 months for both groups. All functional tests in the second phase of the study will be performed via supervision teleconference for all the participants with an expert physiotherapist. Findings from this project will contribute to the field of telerehabilitation in patients with COVID-19 after hospital discharge and will provide critical preliminary data for the design and implementation of a larger, randomized control trial assessing the impact of telerehabilitation on long-term clinical outcomes following infection or re-infection from coronaviruses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm single blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention Arm: Telerehabilitation | Active comparator | Device: TelerehabilitationThe treatment arm will be given up to 1-hour resistive training exercises, breathing exercises and aerobic exercises administered by an expert physiotherapist via teleconference (telerehabilitation). Every ten days one physiotherapist will record the individualized exercise program, will reevaluate the magnitude of exercise for each patient and reinforce to continue or increase exercise magnitude. |
| No Intervention: Conventional teleconference | No intervention | –The usual care arm will receive standard communication via teleconference every ten days for a six-month period without any specific recommendations and exercise prescription for home training. The control arm will be subject to the same assessments as the experimental arm at the start, and at the 3 and 6 months period. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female adults with age from 20 to 65 years hospitalized due COVID-19 infection. Able to give consent
Key exclusion criteria (1 listed)
- the presence of mental illness, any physical disability that makes difficult to mobilize patients, severe heart disease, severe musculoskeletal pain, vascular aneurysms, severe neurological condition, pregnancy
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 |
|---|---|---|
| TelerehabilitationThe treatment arm will be given up to 1-hour breathing exercises, aerobic and resistive training exercises administered by a physiotherapist via a telerehabilitation device every 10 days for a six-month period. | Device | Experimental Intervention Arm: Telerehabilitation |
Primary outcome
Physical Performance
Time frame: Change From Baseline in SPPB Scores at 3 and 6 months
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Cardiorespiratory fitness
Time frame: Change From Baseline in 3MST Scores at 3 and 6 months
The 3 minute step test (3MST) is a field test designed to measure aerobic (cardiovascular) fitness. Participants step up and down a 30-cm high step for 3 minutes at a pace of 24 steps per minute. Oxygen saturation, heart rate and fatigue (using the Borg 0-10 scale) will be assessed at the beginning, at the end and every minute after full recovery in order to evaluate the heart's, fatigue and saturation recovery rates. Because it is a submaximal test it can easily be completed at home and administrated via video conferencing.
Lower limb Strength
Time frame: Change From Baseline in STST Scores at 3 and 6 months
The 30 sec sit-to-stand test (STST) is a feasible alternative for measuring lower limb muscle strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 seconds.
Health Related Quality of Life
Time frame: Change From Baseline in SF-36 Scores at 3 and 6 months
The Short Form Health Survey (SF-36) consists of 36 questions spanning 8 health (physical and mental) domains. The eight domains are: vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Converging the individual scores into z-score, a standardized score (mean 50) is provided for each domain allowing comparisons between populations. The lower the score the more disability. It is a valid patient-reported survey of health-related quality of life in patient populations and it is responsive to change following therapeutic interventions.
Anxiety and Depression
Time frame: Change From Baseline in HADS Scores at 3 and 6 months
Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale
Physical Activity
Time frame: Change From Baseline in IPAQ Scores at 3 and 6 months
The International Physical Activity Questionnaire (IPAQ) is a frequently used instrument for the evaluation of physical activity (PA). It was developed in order to assess physical activity in adults aged 18-65 years. The greek version of IPAQ, (IPAQ-Gr) sums up moderate, vigorous, walking physical activities over the previous seven-day period and generate a total physical activity score (PAscore), expressed in MET-minutes per week (MET.min.wk-1 ). Based on the IPAQ scoring procedure, physical activity status is classified into three categories (PAclasses): (1) low PAclass, insufficiently active subjects (total PAscore < 600 MET.min.wk-1); (2) moderate PAclass (total PAscore ≥ 600 MET.min.wk-1 or vigorous PAscore ≥ 480 MET.min.wk-1) and (3) high PAclass (total PAscore ≥ 3000 MET.min.wk-1 or vigorous PAscore ≥ 1500 MET.min.wk-1).
2 secondary outcomes
Fatigue
Time frame: Change From Baseline in Borg CR-10 Scores at 3 and 6 months
Dyspnea
Time frame: Change From Baseline in MMRC Scores at 3 and 6 months
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 28 Dec 2023.
- Background: PubMed 19622498Papathanasiou G, Georgoudis G, Papandreou M, Spyropoulos P, Georgakopoulos D, Kalfakakou V, Evangelou A. Reliability measures of the short International Physical Activity Questionnaire (IPAQ) in Greek young adults. Hellenic J Cardiol. 2009 Jul-Aug;50(4):283-94.
- Background: PubMed 31395008Bergland A, Strand BH. Norwegian reference values for the Short Physical Performance Battery (SPPB): the Tromso Study. BMC Geriatr. 2019 Aug 8;19(1):216. doi: 10.1186/s12877-019-1234-8.
- Background: PubMed 20381912Wassenberg MW, Severs D, Bonten MJ. Psychological impact of short-term isolation measures in hospitalised patients. J Hosp Infect. 2010 Jun;75(2):124-7. doi: 10.1016/j.jhin.2010.01.023. Epub 2010 Apr 10.
- 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.
ELENI KORTIANOU, PhD, PT study director
Clinical Exercise Physiology and Rehabilitation Research Laboratory
ELENI KAPRELI, PhD, PT study chair
Clinical Exercise Physiology and Rehabilitation Research Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with COVID-19 and Comorbidities and Coexisting Conditions, run by University of Thessaly at 1 site in Greece.
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 1 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: finished, as of the sponsor's last update on 28 Dec 2023. 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 Greece. 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. 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?
Physical Performance (time frame: Change From Baseline in SPPB Scores at 3 and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368845, which also lists 3 linked publications.
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 28 Dec 2023.