Stroke SequelaeSEDMA_StrokeNCT04576598
Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program
A study testing Self-management program to increase physical activity levels and Education information in people with Stroke Sequelae, run by University of Valencia at 2 sites in Spain.
Trial summary
Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Self-management program to increase physical activity levels and Education information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Jan 2020to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having sequelae after stroke of at least 6 months of evolution
- being community-dwelling (minimum 2 months since the last stroke)
- having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2)
- having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed
Who cannot join
- not having a strength deficit in the lower limbs or walking difficulties
- having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Department of Physiotherapy. University of Valencia
Valencia, 46010
M.Luz Sánchez-Sánchez, PhD, 0034963983853, M.Luz.Sanchez@uv.es
M.Arantzazu Ruescas-Nicolau, PhD
- Recruiting
University of Valencia
Valencia, 46010
Sánchez-Sánchez ML, 0034-963 98 38 55, M.Luz.Sanchez@uv.es
Ruescas-Nicolau A, 0034-963 98 38 55, Arancha.Ruescas@uv.es
About this study
Official title: Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program
Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account.
Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty.
To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.
- Conditions
- Stroke Sequelae
- Being tested
- Self-management program to increase physical activity levels, Education information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management program to increase physical activity levelsOther
Also called Physiotherapy, Physical therapy, Physical exercise program
Information and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program.
Education informationOther
Education on the importance of active lifestyle habits post-stroke.
| Study group | Role | What they receive |
|---|---|---|
| Self-management group to increase physical activity levels | Experimental | This group will perform a self-management program along 6 months. This program will aim to increase the level of physical activity and adherence to healthier lifestyle habits and will be carried out through several sessions that will incorporate: education, goal setting, identification of barriers, self-control and feedback. Receives: Other: Self-management program to increase physical activity levels |
| Control group | Active comparator | This group will participate in the initial educational session and will be given a leaflet with recommendations for physical activity to follow throughout the six months. Receives: Other: Education information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Physical activity level at a year
International Physical Activity Questionnaire (IPAQ)
Measured: 1 year
Change from Baseline Sedentary time at a year
ActiGraph wGT3X-BT accelerometers
Measured: 1 year
Secondary outcomes (7)
Change from Baseline Functional Mobility at a year
Timed Up and Go Test
Measured: 1 year
Change from Baseline Lower extremity functioning at a year
Short Physical Performance Battery (SPPB)
Measured: 1 year
Change from Baseline Postural stability in standing at a year
Posturography with the Wii Balance Board
Measured: 1 year
Change from Baseline Frailty at a year
Fried's frailty phenotype
Measured: 1 year
Change from Baseline Sarcopenia at a year
Bioimpedance with Tanita BC-418MA
Measured: 1 year
Change from Baseline Bone mineral density at a year
Ultrasound bone densitometry with Sonost3000
Measured: 1 year
Change from Baseline Motion analysis at a year
Inertial sensors based motion capture system Xsens-DOT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start10 Jan 2020
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- M.Luz Sánchez Sánchez, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576598
- Sponsor's protocol ID
- GV/2019/161
- Acronym
- SEDMA_Stroke
- Status last verified
- Dec 2022
- First submitted
- 10 Sep 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PubMed 24352519Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2.
PubMed 30051462Howe MD, McCullough LD. Prevention and management of stroke in women. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):403-15. doi: 10.1586/14779072.2015.1020300. Epub 2015 Mar 6.
PubMed 25747877Bushnell CD, Reeves MJ, Zhao X, Pan W, Prvu-Bettger J, Zimmer L, Olson D, Peterson E. Sex differences in quality of life after ischemic stroke. Neurology. 2014 Mar 18;82(11):922-31. doi: 10.1212/WNL.0000000000000208. Epub 2014 Feb 7.
PubMed 24510493Mackie P, Weerasekara I, Crowfoot G, Janssen H, Holliday E, Dunstan D, English C. What is the effect of interrupting prolonged sitting with frequent bouts of physical activity or standing on first or recurrent stroke risk factors? A scoping review. PLoS One. 2019 Jun 13;14(6):e0217981. doi: 10.1371/journal.pone.0217981. eCollection 2019.
PubMed 31194799Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Stroke. 2004 May;35(5):1230-40. doi: 10.1161/01.STR.0000127303.19261.19. No abstract available.
PubMed 15105522Prior PL, Suskin N. Exercise for stroke prevention. Stroke Vasc Neurol. 2018 Jun 26;3(2):59-68. doi: 10.1136/svn-2018-000155. eCollection 2018 Jun.
PubMed 30191075Jones F, Riazi A. Self-efficacy and self-management after stroke: a systematic review. Disabil Rehabil. 2011;33(10):797-810. doi: 10.3109/09638288.2010.511415. Epub 2010 Aug 27.
PubMed 20795919Preston E, Dean CM, Ada L, Stanton R, Brauer S, Kuys S, Waddington G. Promoting physical activity after stroke via self-management: a feasibility study. Top Stroke Rehabil. 2017 Jul;24(5):353-360. doi: 10.1080/10749357.2017.1304876. Epub 2017 Mar 23.
PubMed 28335690
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program
- ClinicalTrials.gov ID
- NCT04576598
- Acronym / sponsor ID
- SEDMA_Stroke / GV/2019/161
- Conditions
- Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 6 Oct 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.
Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account.
Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty.
To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Self-management group to increase physical activity levels | Experimental | Other: Self-management program to increase physical activity levelsThis group will perform a self-management program along 6 months. This program will aim to increase the level of physical activity and adherence to healthier lifestyle habits and will be carried out through several sessions that will incorporate: education, goal setting, identification of barriers, self-control and feedback. |
| Control group | Active comparator | Other: Education informationThis group will participate in the initial educational session and will be given a leaflet with recommendations for physical activity to follow throughout the six months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having sequelae after stroke of at least 6 months of evolution
- being community-dwelling (minimum 2 months since the last stroke)
- having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2)
- having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed
Key exclusion criteria (2 listed)
- not having a strength deficit in the lower limbs or walking difficulties
- having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)
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 |
|---|---|---|
| Self-management program to increase physical activity levelsAlso: Physiotherapy, Physical therapy, Physical exercise programInformation and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program. | Other | Self-management group to increase physical activity levels |
| Education informationEducation on the importance of active lifestyle habits post-stroke. | Other | Control group |
Primary outcome
Change from Baseline Physical activity level at a year
Time frame: 1 year
International Physical Activity Questionnaire (IPAQ)
Change from Baseline Sedentary time at a year
Time frame: 1 year
ActiGraph wGT3X-BT accelerometers
7 secondary outcomes
Change from Baseline Functional Mobility at a year
Time frame: 1 year
Change from Baseline Lower extremity functioning at a year
Time frame: 1 year
Change from Baseline Postural stability in standing at a year
Time frame: 1 year
Change from Baseline Frailty at a year
Time frame: 1 year
Change from Baseline Sarcopenia at a year
Time frame: 1 year
Change from Baseline Bone mineral density at a year
Time frame: 1 year
Change from Baseline Motion analysis at a year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 24352519Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
- Background: PubMed 30051462Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2.
- Background: PubMed 25747877Howe MD, McCullough LD. Prevention and management of stroke in women. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):403-15. doi: 10.1586/14779072.2015.1020300. Epub 2015 Mar 6.
- Background: PubMed 24510493Bushnell CD, Reeves MJ, Zhao X, Pan W, Prvu-Bettger J, Zimmer L, Olson D, Peterson E. Sex differences in quality of life after ischemic stroke. Neurology. 2014 Mar 18;82(11):922-31. doi: 10.1212/WNL.0000000000000208. Epub 2014 Feb 7.
- Background: PubMed 31194799Mackie P, Weerasekara I, Crowfoot G, Janssen H, Holliday E, Dunstan D, English C. What is the effect of interrupting prolonged sitting with frequent bouts of physical activity or standing on first or recurrent stroke risk factors? A scoping review. PLoS One. 2019 Jun 13;14(6):e0217981. doi: 10.1371/journal.pone.0217981. eCollection 2019.
- Background: PubMed 15105522Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Stroke. 2004 May;35(5):1230-40. doi: 10.1161/01.STR.0000127303.19261.19. No abstract available.
- Background: PubMed 30191075Prior PL, Suskin N. Exercise for stroke prevention. Stroke Vasc Neurol. 2018 Jun 26;3(2):59-68. doi: 10.1136/svn-2018-000155. eCollection 2018 Jun.
- Background: PubMed 20795919Jones F, Riazi A. Self-efficacy and self-management after stroke: a systematic review. Disabil Rehabil. 2011;33(10):797-810. doi: 10.3109/09638288.2010.511415. Epub 2010 Aug 27.
- Background: PubMed 28335690Preston E, Dean CM, Ada L, Stanton R, Brauer S, Kuys S, Waddington G. Promoting physical activity after stroke via self-management: a feasibility study. Top Stroke Rehabil. 2017 Jul;24(5):353-360. doi: 10.1080/10749357.2017.1304876. Epub 2017 Mar 23.
- 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.
M.Luz Sánchez Sánchez, PhD principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management program to increase physical activity levels and Education information in people with Stroke Sequelae, run by University of Valencia at 2 sites in Spain.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M.Luz Sánchez Sánchez, PhD (0034963983853, M.Luz.Sanchez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Physical activity level at a year (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04576598, which also lists 10 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 2022.