End Stage Renal DiseaseNCT06313892
The Effect of Home-Based Tele-Exercise on Dialysis Patients
A study testing Home-based Exercise in people with End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial summary
The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele-exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Complication
- What is being tested?
- Home-based Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIran
- Study dates
- 15 Mar 2024to 2 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being Aged 18 years and over
- Regular in-center HD 3 times a week
- Completed at least 1 year of stable HD history
- Without myocardial infarction within past 3 months
- Permission from their doctors
- Have decision making capacity to enable them to give informed consent to take part in the study
- Have access to a smart device (e.g. smart phone, laptop or tablet), and have internet access
Who cannot join
- Unstable cardiac status (angina, decompensated congestive heart failure, severe vascular stenosis, uncontrolled arrhythmias, etc.).
- Active infection or acute medical illness.
- Hemodynamic instability.
- Labile glycemic control.
- Unstable HD treatment or an ongoing change or titration in the medication regimen.
- Inability to exercise due to severe mobility limitations, although modifications will be permitted for amputations with prosthesis or seated exercise.
Show all 10Show fewer
- Severe musculoskeletal pain at rest or with minimal activity.
- Inability to sit, stand, or walk unassisted (walking aids such as a cane or walker will be allowed).
- Shortness of breath at rest or during activities of daily living (NYHA Class IV).
- Participation in exercise ≥3 times per week addressing ≥2 exercise domains
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Synchronous Home-Based Tele-Exercise on Physical Function, Daily Physical Activity and Frailty in Dialysis Patients: A Randomized Pilot Trial
The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele-exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy.
Read the detailed description
Patients with renal failure undergoing maintenance dialysis (HD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality.
According to studies, regular exercise is beneficial for patients at all stages, and the current recommendations for the prevention and management of side effects in HD patients, especially in the elderly, is regular exercise because it improves physical performance and PA . Currently, due to the unfamiliarity of dialysis center staff and nephrologists with the benefits of exercise, only 10% of the world's clinics have a plan to exercise during HD. Therefore, home-based exercise programs are a suitable option for patients to reduce their costs and make it easy to adhere to.
Home-based exercise has the potential to utilize higher volume and higher intensity training if activity is monitored. However, many of these programs are unsupervised and this is one of the major disadvantages of home-based exercise programs. Lack of prior knowledge about the safety and benefits of exercise programs, fear of injury, and lack of interest or motivation are barriers to exercise at home.
Tele-rehabilitation is rehabilitation services provided to patients from distant locations using information and communication technologies.Several studies have reported the use of e health-based self-management interventions in chronic kidney disease patients.
However, further research is needed to better understand the extent to which these techniques are acceptable, safe and potentially effective for supporting individuals undergoing HD treatment, given their unique needs and risk profile, is unknown. Our study seeks to address this gap by conducting a pilot evaluation of synchronous home-based tele-exercise intervention designed for HD patient.
Participants were recruited and clinically assessed at Khorshid Dialysis Center in Isfahan, Iran. Eligibility screening and baseline and post-intervention clinical assessments were conducted at Khorshid Dialysis Center. The Pardis Specialized Wellness Institute served as the study sponsor and coordinated the study procedures and the design of the home-based tele-exercise intervention. The synchronous tele-exercise intervention was prescribed, coordinated, and delivered online by the Pardis Specialized Wellness Institute.
- Conditions
- End Stage Renal Disease, Hemodialysis Complication
- Being tested
- Home-based Exercise
- Keywords
- Inactivity, Tele-exercise, Home-based exercise, Hemodialysis, Frailty, Physical function
- Medical subject headings
- Kidney Failure, Chronic, Sedentary Behavior, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based ExerciseBehavioural
The participants in the study group will be given an online personalized exercise program at home in non dialysis days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of tele-exercises will be private and the professional will send the link for each training session and will control the access of the participants. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The participants in the study group will be given an online personalized exercise program at home in non dialysis days. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total. Receives: Behavioral: Home-based Exercise |
| Control group | No intervention | Participants allocated to the control group will serve as a wait-list usual-care comparator. They will receive their usual nephrological care and will be instructed to maintain their usual treatment regimen and customary dietary and physical activity patterns without structured exercise during the 12-week control period. After study completion, they will be offered access to the same tele-exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Determining recruitment as the number of randomized participants divided by the number of patients assessed for eligibility.
Measured: 1 Month
Retention rate
Determining retention rate by the number of randomized participants completing the 12-week follow-up divided by the total number of randomized participants
Measured: 12 Weeks
Adherence rate
Adherence will be quantified using two metrics. Overall session persistence will be calculated as the total number of sessions attended, including partially attended sessions, across all intervention participants divided by the total number of scheduled sessions across all intervention participants. Within-session completeness will be calculated as the percentage of prescribed exercises completed per session, excluding preparation time and skipped items.
Measured: 12 Weeks
Secondary outcomes (3)
Change in daily physical activity level
To examine the effect of home-based synchronous tele-exercise on daily activity level by using Low Physical activity questionnaire.
The questionnaire consists of 11 items that assess various parameters of physical activity within the past 7 days. These parameters include the amount of time spent walking around the neighborhood, for fitness or pleasure, and for transportation purposes, as well as the average duration of sedentary and sitting activities. The questionnaire also calculates the kilocalories expended during light, moderate, vigorous, and total physical activities.
Measured: Baseline and 12 Weeks
Change in Fried frailty phenotype score
To examine the effect of home-based synchronous tele-exercise on change in Fried frailty phenotype score.
Frailty will be assessed using the Fried frailty phenotype, based on five criteria: unintentional weight loss of 10 pounds or more in the prior year by self-report; exhaustion based on responses to two questions about energy; low physical activity based on self-reported frequency of mildly, moderately, and very energetic activity, with low physical activity considered present when both moderately and very energetic activities were reported as occurring hardly ever or never; slow gait speed based on gender- and height-stratified cutoffs; and weak grip strength based on gender- and BMI-stratified cutoffs.
Measured: Baseline and 12 Weeks
Change in physical function level
To examine the effect of home-based synchronous tele-exercise on physical function level by 6 minute walk test and short physical performance battery test
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024
- Primary completion12 Jun 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Tabibi, Dr, Study director, Pardis Specialized Wellness InstituteBobby Cheema, Dr, Principal investigator, School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, AustraliaThomas Wilkinson, Dr, Principal investigator, Diabetes Research Centre, University of Leicester, Leicester, UKKenneth Wilund, Dr, Principal investigator, School of Nutritional Sciences and Wellness, Arizona UniversityFabio Manferedini, Dr, Principal investigator, Dept of Neuroscience and Rehabilitation, University of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313892
- Sponsor's protocol ID
- PA24HD-2-05
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Publications
Painter PL, Nelson-Worel JN, Hill MM, Thornbery DR, Shelp WR, Harrington AR, Weinstein AB. Effects of exercise training during hemodialysis. Nephron. 1986;43(2):87-92. doi: 10.1159/000183805.
PubMed 3713951Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.
PubMed 30342464Hiraki K, Shibagaki Y, Izawa KP, Hotta C, Wakamiya A, Sakurada T, Yasuda T, Kimura K. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial. BMC Nephrol. 2017 Jun 17;18(1):198. doi: 10.1186/s12882-017-0613-7.
PubMed 28623895Darawad MW, Khalil AA. Jordanian dialysis patients' perceived exercise benefits and barriers: a correlation study. Rehabil Nurs. 2013 Nov-Dec;38(6):315-22. doi: 10.1002/rnj.98. Epub 2013 May 23.
PubMed 23703743Rosa CS, Bueno DR, Souza GD, Gobbo LA, Freitas IF Jr, Sakkas GK, Monteiro HL. Factors associated with leisure-time physical activity among patients undergoing hemodialysis. BMC Nephrol. 2015 Nov 27;16:192. doi: 10.1186/s12882-015-0183-5.
PubMed 26613791Ortega-Perez de Villar L, Martinez-Olmos FJ, Perez-Dominguez FB, Benavent-Caballer V, Montanez-Aguilera FJ, Mercer T, Segura-Orti E. Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study. Sci Rep. 2020 May 19;10(1):8302. doi: 10.1038/s41598-020-64372-y.
PubMed 32427935Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.
PubMed 27909047Knott S, Hollis A, Jimenez D, Dawson N, Mabbagu E, Beato M. Efficacy of Traditional Physical Therapy Versus Otago-Based Exercise in Fall Prevention for ALF-Residing Older Adults. J Geriatr Phys Ther. 2021 Oct-Dec 01;44(4):210-218. doi: 10.1519/JPT.0000000000000285.
PubMed 33534336
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Synchronous Home-Based Tele-Exercise on Physical Function, Daily Physical Activity and Frailty in Dialysis Patients: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06313892
- Acronym / sponsor ID
- PA24HD-2-05
- Conditions
- End Stage Renal Disease, Hemodialysis Complication
- Keywords
- Inactivity, Tele-exercise, Home-based exercise, Hemodialysis, Frailty, Physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 15 Mar 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 objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele-exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy.
Detailed description
Patients with renal failure undergoing maintenance dialysis (HD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality.
According to studies, regular exercise is beneficial for patients at all stages, and the current recommendations for the prevention and management of side effects in HD patients, especially in the elderly, is regular exercise because it improves physical performance and PA . Currently, due to the unfamiliarity of dialysis center staff and nephrologists with the benefits of exercise, only 10% of the world's clinics have a plan to exercise during HD. Therefore, home-based exercise programs are a suitable option for patients to reduce their costs and make it easy to adhere to.
Home-based exercise has the potential to utilize higher volume and higher intensity training if activity is monitored. However, many of these programs are unsupervised and this is one of the major disadvantages of home-based exercise programs. Lack of prior knowledge about the safety and benefits of exercise programs, fear of injury, and lack of interest or motivation are barriers to exercise at home.
Tele-rehabilitation is rehabilitation services provided to patients from distant locations using information and communication technologies.Several studies have reported the use of e health-based self-management interventions in chronic kidney disease patients.
However, further research is needed to better understand the extent to which these techniques are acceptable, safe and potentially effective for supporting individuals undergoing HD treatment, given their unique needs and risk profile, is unknown. Our study seeks to address this gap by conducting a pilot evaluation of synchronous home-based tele-exercise intervention designed for HD patient.
Participants were recruited and clinically assessed at Khorshid Dialysis Center in Isfahan, Iran. Eligibility screening and baseline and post-intervention clinical assessments were conducted at Khorshid Dialysis Center. The Pardis Specialized Wellness Institute served as the study sponsor and coordinated the study procedures and the design of the home-based tele-exercise intervention. The synchronous tele-exercise intervention was prescribed, coordinated, and delivered online by the Pardis Specialized Wellness Institute.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Home-based ExerciseThe participants in the study group will be given an online personalized exercise program at home in non dialysis days. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total. |
| Control group | No intervention | –Participants allocated to the control group will serve as a wait-list usual-care comparator. They will receive their usual nephrological care and will be instructed to maintain their usual treatment regimen and customary dietary and physical activity patterns without structured exercise during the 12-week control period. After study completion, they will be offered access to the same tele-exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being Aged 18 years and over
- Regular in-center HD 3 times a week
- Completed at least 1 year of stable HD history
- Without myocardial infarction within past 3 months
- Permission from their doctors
Key exclusion criteria (10 listed)
- Unstable cardiac status (angina, decompensated congestive heart failure, severe vascular stenosis, uncontrolled arrhythmias, etc.).
- Active infection or acute medical illness.
- Hemodynamic instability.
- Labile glycemic control.
- Unstable HD treatment or an ongoing change or titration in the medication regimen.
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 |
|---|---|---|
| Home-based ExerciseThe participants in the study group will be given an online personalized exercise program at home in non dialysis days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of tele-exercises will be private and the professional will send the link for each training session and will control the access of the participants. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total. | Behavioural | Exercise group |
Primary outcome
Recruitment rate
Time frame: 1 Month
Determining recruitment as the number of randomized participants divided by the number of patients assessed for eligibility.
Retention rate
Time frame: 12 Weeks
Determining retention rate by the number of randomized participants completing the 12-week follow-up divided by the total number of randomized participants
Adherence rate
Time frame: 12 Weeks
Adherence will be quantified using two metrics. Overall session persistence will be calculated as the total number of sessions attended, including partially attended sessions, across all intervention participants divided by the total number of scheduled sessions across all intervention participants. Within-session completeness will be calculated as the percentage of prescribed exercises completed per session, excluding preparation time and skipped items.
3 secondary outcomes
Change in daily physical activity level
Time frame: Baseline and 12 Weeks
Change in Fried frailty phenotype score
Time frame: Baseline and 12 Weeks
Change in physical function level
Time frame: Baseline and 12 Weeks
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 31 Aug 2026.
- Background: PubMed 3713951Painter PL, Nelson-Worel JN, Hill MM, Thornbery DR, Shelp WR, Harrington AR, Weinstein AB. Effects of exercise training during hemodialysis. Nephron. 1986;43(2):87-92. doi: 10.1159/000183805.
- Background: PubMed 30342464Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.
- Background: PubMed 28623895Hiraki K, Shibagaki Y, Izawa KP, Hotta C, Wakamiya A, Sakurada T, Yasuda T, Kimura K. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial. BMC Nephrol. 2017 Jun 17;18(1):198. doi: 10.1186/s12882-017-0613-7.
- Background: PubMed 23703743Darawad MW, Khalil AA. Jordanian dialysis patients' perceived exercise benefits and barriers: a correlation study. Rehabil Nurs. 2013 Nov-Dec;38(6):315-22. doi: 10.1002/rnj.98. Epub 2013 May 23.
- Background: PubMed 26613791Rosa CS, Bueno DR, Souza GD, Gobbo LA, Freitas IF Jr, Sakkas GK, Monteiro HL. Factors associated with leisure-time physical activity among patients undergoing hemodialysis. BMC Nephrol. 2015 Nov 27;16:192. doi: 10.1186/s12882-015-0183-5.
- Background: PubMed 32427935Ortega-Perez de Villar L, Martinez-Olmos FJ, Perez-Dominguez FB, Benavent-Caballer V, Montanez-Aguilera FJ, Mercer T, Segura-Orti E. Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study. Sci Rep. 2020 May 19;10(1):8302. doi: 10.1038/s41598-020-64372-y.
- Background: PubMed 27909047Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.
- Background: PubMed 33534336Knott S, Hollis A, Jimenez D, Dawson N, Mabbagu E, Beato M. Efficacy of Traditional Physical Therapy Versus Otago-Based Exercise in Fall Prevention for ALF-Residing Older Adults. J Geriatr Phys Ther. 2021 Oct-Dec 01;44(4):210-218. doi: 10.1519/JPT.0000000000000285.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
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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.
Mohammad Ali Tabibi, Dr study director
Pardis Specialized Wellness Institute
Bobby Cheema, Dr principal investigator
School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
Thomas Wilkinson, Dr principal investigator
Diabetes Research Centre, University of Leicester, Leicester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise in people with End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
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 7 inclusion and 10 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 31 Aug 2026. 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 Iran. 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?
Recruitment rate (time frame: 1 Month). The study lists 3 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 NCT06313892, which also lists 8 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 31 Aug 2026.