End Stage Renal Disease on DialysisVRINCT04046042
Virtual Reality Intradialysis: Last vs. First Part of the Session
A study testing Conventional exercise and Exercise during the last two hours of the hemodialysis session in people with End Stage Renal Disease on Dialysis and Hemodialysis Complication, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Hemodialysis Complication
- What is being tested?
- Conventional exercise and Exercise during the last two hours of the hemodialysis session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2019to 30 Aug 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
- At least 3 months in hemodialysis treatment
- Clinically stable
Who cannot join
- Recent cardiac events (less than 3 months)
- Unable to exercise
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Manises
Manises, Valencia, 46940
EVA SEGURA-ORTÍ, PhD, 00 34 671580094, eva.segura@gmail.com
About this study
Official title: Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session
The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.
The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.
Read the detailed description
Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.
The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.
- Being tested
- Conventional exercise, Exercise during the last two hours of the hemodialysis session
- Keywords
- Exercise, Virtual reality, physical function, health-related quality of life, hemodynamic instability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional exerciseOther
Virtual reality exercise performed during the first two hours of the hemodialysis session
Exercise during the last two hours of the hemodialysis sessionOther
Virtual reality exercise performed during the last two hours of the hemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise time | Active comparator | During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented Receives: Other: Conventional exercise |
| Experimental group | Experimental | During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented Receives: Other: Exercise during the last two hours of the hemodialysis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Measured: 3 Months
Number of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Measured: 6 Months
Number of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Measured: 12 Months
Secondary outcomes (18)
Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months
Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage.
Measured: Baseline and 3 months
Change from baseline dialysis dose at 3 months, 6 months, and 12 months
Dialysis dose, measured through Kt/V
Measured: Baseline, 3 Months, 6 months and 12 months
Adherence, as number of sessions performed /number of sessions offered
Sessions performed/sessions offered
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline short physical performance battery at 3 months, 6 months, and 12 months
Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline gait speed at 3 months, 6 months, and 12 months
Speed to cover 4 meters, in meters/second
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline handgrip at 3 months, 6 months, and 12 months
Bilateral handgrip strength
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months
Muscle strength measured with a handheld dynamometer on the main muscle groups during hemodialysis
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg standing test at 3 months, 6 months, and 12 months
Time achieved while standing on one leg
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months
Time to perform 10 repetitions sit to stand
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months
Sit to stand repetitions performed in 60 seconds
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline timed up and go at 3 months, 6 months, and 12 months
Time to stand up, walk 3 meters, come back and sit down again
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months
Number of heel rise repetitions achieved
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months
Number of meters walked in 6 minutes
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline Physical activity level at 3 months, 6 months, and 12 months
Physical activity questionnaires
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline Health related quality of life at 3 months, 6 months, and 12 months
Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline Cognitive function at 3 months, 6 months, and 12 months
Mini-mental State Examination questionnaire, score ranges from 0 to 30, higher scores indicates higher cognitive function
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months
Functional evaluation by Barthel Index, to evaluate capacity to perform daily tasks without assistance. Score ranges from 0 to 100. Higher scores indicates higher capacity to perform activities.
Measured: Baseline, 3 Months, 6 months and 12 months
Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months
Frailty will be measured from 0 to 5, depending on how many of the 5 components are present in each subject, being 5 the highest frailty score
Measured: Baseline, 3 Months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start2 Sep 2019
- Primary completion29 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two exercise groups, during the first two hours of hemodialysis or during the last two hours of hemodialysis
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva Segura-Ortí, PhD, Principal investigator, Universidad CEU Cardenal Herrera, UCH CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046042
- Sponsor's protocol ID
- ReVID
- Acronym
- VRI
- Status last verified
- Jun 2024
- First submitted
- 1 Aug 2019
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Segura-Orti E, Perez-Dominguez B, Ortega-Perez de Villar L, Melendez-Oliva E, Martinez-Gramage J, Garcia-Maset R, Gil-Gomez JA. Virtual reality exercise intradialysis to improve physical function: A feasibility randomized trial. Scand J Med Sci Sports. 2019 Jan;29(1):89-94. doi: 10.1111/sms.13304. Epub 2018 Oct 7.
PubMed 30230041Segura-Orti E, Garcia-Testal A. Intradialytic virtual reality exercise: Increasing physical activity through technology. Semin Dial. 2019 Jul;32(4):331-335. doi: 10.1111/sdi.12788. Epub 2019 Mar 27.
PubMed 30916415Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
PubMed 21719637Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
PubMed 20701722Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
PubMed 20098466Garcia Testal A, Garcia Maset R, Hervas Marin D, Perez-Dominguez B, Royo Maicas P, Rico Salvador IS, Melendez-Oliva E, Molina Aracil J, Murgui Chiva M, Del Pozo Blanco O, Olague Diaz P, Fernandez Najera JE, Torregrosa De Juan E, Benedito Carrera C, Segura-Orti E. Influence of Physical Exercise on the Dialytic Adequacy Parameters of Patients on Hemodialysis. Ther Apher Dial. 2019 Apr;23(2):160-166. doi: 10.1111/1744-9987.12762. Epub 2018 Oct 19.
PubMed 30226299Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
PubMed 30133445Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
PubMed 19473613Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
PubMed 18336134
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session
- ClinicalTrials.gov ID
- NCT04046042
- Acronym / sponsor ID
- VRI / ReVID
- Keywords
- Exercise, Virtual reality, physical function, health-related quality of life, hemodynamic instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 29 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 6 Aug 2019 (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 main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.
The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.
Detailed description
Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.
The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two exercise groups, during the first two hours of hemodialysis or during the last two hours of hemodialysis
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise time | Active comparator | Other: Conventional exerciseDuring 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented |
| Experimental group | Experimental | Other: Exercise during the last two hours of the hemodialysis sessionDuring 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3 months in hemodialysis treatment
- Clinically stable
Key exclusion criteria (2 listed)
- Recent cardiac events (less than 3 months)
- Unable to exercise
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 |
|---|---|---|
| Conventional exerciseVirtual reality exercise performed during the first two hours of the hemodialysis session | Other | Conventional exercise time |
| Exercise during the last two hours of the hemodialysis sessionVirtual reality exercise performed during the last two hours of the hemodialysis session | Other | Experimental group |
Primary outcome
Number of hypotension episodes
Time frame: 3 Months
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Number of hypotension episodes
Time frame: 6 Months
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Number of hypotension episodes
Time frame: 12 Months
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
18 secondary outcomes
Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months
Time frame: Baseline and 3 months
Change from baseline dialysis dose at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Adherence, as number of sessions performed /number of sessions offered
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline short physical performance battery at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline gait speed at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline handgrip at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg standing test at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline timed up and go at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline Physical activity level at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline Health related quality of life at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline Cognitive function at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months
Time frame: Baseline, 3 Months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 30230041Segura-Orti E, Perez-Dominguez B, Ortega-Perez de Villar L, Melendez-Oliva E, Martinez-Gramage J, Garcia-Maset R, Gil-Gomez JA. Virtual reality exercise intradialysis to improve physical function: A feasibility randomized trial. Scand J Med Sci Sports. 2019 Jan;29(1):89-94. doi: 10.1111/sms.13304. Epub 2018 Oct 7.
- Background: PubMed 30916415Segura-Orti E, Garcia-Testal A. Intradialytic virtual reality exercise: Increasing physical activity through technology. Semin Dial. 2019 Jul;32(4):331-335. doi: 10.1111/sdi.12788. Epub 2019 Mar 27.
- Background: PubMed 21719637Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
- Background: PubMed 20701722Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
- Background: PubMed 20098466Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
- Background: PubMed 30226299Garcia Testal A, Garcia Maset R, Hervas Marin D, Perez-Dominguez B, Royo Maicas P, Rico Salvador IS, Melendez-Oliva E, Molina Aracil J, Murgui Chiva M, Del Pozo Blanco O, Olague Diaz P, Fernandez Najera JE, Torregrosa De Juan E, Benedito Carrera C, Segura-Orti E. Influence of Physical Exercise on the Dialytic Adequacy Parameters of Patients on Hemodialysis. Ther Apher Dial. 2019 Apr;23(2):160-166. doi: 10.1111/1744-9987.12762. Epub 2018 Oct 19.
- Background: PubMed 30133445Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
- Background: PubMed 19473613Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
- Background: PubMed 18336134Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
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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.
Eva Segura-Ortí, PhD principal investigator
Universidad CEU Cardenal Herrera, UCH CEU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional exercise and Exercise during the last two hours of the hemodialysis session in people with End Stage Renal Disease on Dialysis and Hemodialysis Complication, run by Cardenal Herrera University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Segura-Ortí, PhD (00 34 671580094, eva.segura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypotension episodes (time frame: 3 Months). 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 NCT04046042, which also lists 9 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 14 Jun 2024.