HemodialysisNCT06788054
Intradialysis Exercise Functional Capacity, Body Composition and Survival in Hemodialysis Patients
A study testing intradialysis exercise in people with Hemodialysis and Kidney Disease, Chronic, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
Chronic kidney disease and renal replacement treatments (hemodialysis, peritoneal dialysis, kidney transplant) produce various alterations at the level of muscle, bones, fat content and the heart; can alter physical capabilities such as muscle strength, resistance to climb a step repeatedly intensely, and the ability… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hemodialysis, Kidney Disease, Chronic, Physical Activity
- What is being tested?
- intradialysis exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jan 2025to 30 May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged between 18-50 years.
- Patients who receive regular hemodialysis sessions 3 times a week, reported through the clinical record.
- Patients with a clinical history of being treated with HD for at least 1 previous year (reported by clinical record).
- Patients without a history of myocardial infarction in the last 3 months (reported by clinical record).
- Patients who are not in a kidney transplant protocol to be performed during the next 12 months.
- Patients who have permission from their nephrology specialist to participate.
Show all 18Show fewer
- Patients who agree to participate in the study, and who voluntarily sign the informed consent (IC) form.
- Patients without a history of coronary artery disease in the last 4 months (reported by clinical record).
- Patients without myocardial instability (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias), reported by clinical record.
- Patients without active infectious process (reported by clinical record).
- Patients without extreme changes in blood glucose levels (hyperglycemia or hypoglycemia), reported by clinical record.
- Patients without neurological, respiratory or skeletal muscle diseases or disorders that are aggravated by exercise (reported by clinical record).
- Patients without inability to sit, stand or walk without assistance (walking device such as cane or walker is allowed) self-reported.
- Patients without severe anemia (Hb < 8.0 g/dL), reported by clinical record.
- Female patients should not be under sex hormone treatment or hormone replacement therapy for menopause (self-reported).
- Patients without lupus erythematosus as the etiology of CKD, reported by clinical record.
- Physically inactive (Do not perform physical exercise of more than 150 minutes per week on a regular basis according to data from the World Health Organization).
- Patients who do not have amputations of any of the extremities.
Who cannot join
- If the patient presents any disease, or neurological, respiratory or skeletal muscle disorder during the development of the physical capacity tests, or during the execution of the protocol, which is aggravated by the practice of physical exercise.
- When the patient voluntarily decides to leave the study.
- When the patient begins additional strength or aerobic training.
- Patients who receive a kidney transplant during the development of the exercise protocol or follow-up during the 8-month follow-up period.
- Patients who decide to belong to the group that will perform intradialytic exercise.
- When for any reason the exercise is suspended for more than three continuous times.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Departamento de Ciencias Médicas Universidad de Guanajuato
León, Guanajuato, 37210
About this study
Official title: Effect of a 12-week Intradialysis Exercise Program on Functional Capacity, Body Composition and Survival in Hemodialysis Patients: a Randomized Clinical Trial
Chronic kidney disease and renal replacement treatments (hemodialysis, peritoneal dialysis, kidney transplant) produce various alterations at the level of muscle, bones, fat content and the heart; can alter physical capabilities such as muscle strength, resistance to climb a step repeatedly intensely, and the ability to move the joints freely, in addition to producing an increase or decrease in weight and alterations in its distribution (for example, decreasing muscle and increase fat). The above, added to the particular factors of hemodialysis such as the reduction in daily time to exercise due to the sessions, or the fatigue after it, can together generate greater repercussions on functional capacity and thus increase the risk of suffering from cardiovascular problems. and accelerate the evolution of the disease.
Therefore, this study aims to determine the effect of a 12-week supervised physical exercise program during hemodialysis on strength and ability to move, the amount of fat and muscle in the body, as well as bone wear. ; and compare these results with a group of patients who do not perform supervised exercise. In addition, it will be determined how exercise can act in the long term, preventing the risk of hospitalization and death due to cardiovascular causes. The above is useful in order to establish recommendations and protocols that help us increase the quality of life and survival of the person.
Read the detailed description
Background: In Mexico, Chronic Kidney Disease (CKD) has a high prevalence and is considered one of the leading causes of death. Hemodialysis (HD) is the primary renal replacement therapy; however, it is associated with significant declines in functional capacity, body composition alterations, morbidity, hospitalization, and mortality with rates that can be 30% higher than those in the general population not on HD. It is estimated that 50% of patients die within the first three years of starting HD, primarily due to cardiovascular complications. Intradialytic exercise has been linked to improvements in functional capacity and metabolic and cardiovascular parameters in HD patients. Despite these benefits, there are few studies examining the relationship between intradialytic physical exercise and increased survival in CKD patients.Objective: To analyze the effects of a 12-week intradialytic exercise program on functional capacity, body composition, and survival in patients undergoing hemodialysis. Hypothesis: A 12-week intradialytic exercise program will improve functional capacity, body composition, and survival rates in hemodialysis patients. Materials and Methods: This clinical trial will utilize a randomized design with two groups of HD patients. The intervention group will participate in an aerobic and muscular resistance exercise program during the second hour of dialysis, three times a week for 12 weeks. The control group will not participate in intradialytic exercise but will receive guidance on standard treatment, including recommendations for aerobic and resistance exercises at home three times a week. All participants (both the intervention and control groups) will be assessed for body composition using bioelectrical impedance analysis, functional capacity through the 6-minute walk test, the 30-second sit-to-stand test, and muscle strength measured by hand dynamometry. The primary outcome variable will be the survival rate at eight months of follow-up after the exercise intervention, and during this time, the International Physical Activity Questionnaire (IPAQ-short version) will be administered every two months.
- Conditions
- Hemodialysis, Kidney Disease, Chronic, Physical Activity, Physical Deconditioning, Physical Function, Survival
- Being tested
- intradialysis exercise
- Keywords
- hemodialysis, physical capacity, chronic kidney disease, body composition, intradialysis exercise
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradialysis exerciseOther
moderate intensity aerobic and muscular resistance exercise protocol lasting 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic kidney disease on hemodialysis with intradialytic exercise | Experimental | Not described Receives: Other: intradialysis exercise |
| patients with chronic kidney disease on hemodialysis without intradialytic exercise | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
Handgrip strength will be assessed with a dynamometer, which is measured in kilograms (kg). This will be measured on a day without dialysis from the arm without an arteriovenous fistula for patients with a fistula and the dominant hand for patients with a central venous catheter. The test will be performed according to the instructions of the American Society of Hand Therapists, the patient will exert the greatest possible grip strength by flexing the fingers of the hand to the maximum.Three evaluations will be carried out, considering a one-minute rest between each one, and the one in which the patient manages to exert the greatest grip will be taken into account.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Cardiorespiratory capacity
Cardiorespiratory capacit will be assessed using the 6-minute walk test, which is measured in meters walked. It is a validated assessment tool for exercise capacity in hemodialysis patients. The test will be performed in a hallway 30 meters long, with a flat surface. During the test, the hallway must be free of any other person's traffic. The hallway will have marks at the start and end of the route, and a mark will be placed every three meters to make the count more accurate. In addition, cones will be placed 0.5 meters after the start and 0.5 meters before the end of the route, which will serve as a reference for the participant to make the turn. All participants will be instructed to make as many laps as possible around the hallway, at the highest speed, but always safely (without running). The meters walked (estimated by the number of laps made) by the patient during the 6 minutes will be counted.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Lower limb functionality:
It will be evaluated by the 30-Sit to stand test through the number of times the patient "gets up and sits" in the chair for 30 seconds, it is a useful, inexpensive, portable and easy to administer test to assess the strength and functional performance of the lower extremities. A 45 cm high and 61 cm deep steel chair will be placed against the wall and the patient will be positioned sitting in the middle of the chair with his back straight, feet flat on the floor and arms crossed on the chest without leaning on the chair, from this position and at the signal "attention - now" the participant will get up completely and return to the initial position as many times as possible during 30 seconds.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Body Weight
body weight (kilograms) will be assessed using a Tanita brand scale, model HD-366.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Height
Height (centimeters) will be evaluated a Seca brand stadiometer, model 213.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Waist circumference
Waist circumference (centimeters) with a non-deformable measuring tape (Lufkin W606PM).
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Body Mass Index
Body mass index (BMI) (kg/m²) will be evaluated dividing the weight in kilograms by the square of the height in meters (BMI = weight [kg]/height [m²]).
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Body composition
For the evaluation of body composition, the bioelectrical impedance technique will be used using the Inbody brand equipment, model S10. With this equipment, the following parameters will be evaluated: percentage and content of fat mass (grams), fat-free mass (grams), visceral fat area (cm), skeletal muscle mass (grams), total body water (liters).
The evaluation will be carried out 30 minutes after the end of the hemodialysis session, on a dialysis day because it is necessary to avoid as much as possible the excess of body water on the day of the evaluation.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Secondary outcomes (1)
Metabolic variables
Will be evaluated of serum levels of hemoglobin (g/dL), creatinine (mg/dL), urea (mg/dL), albumin (g/dL), sodium (mEq/L), potassium (mEq/L) and calcium (mg/dL) will be determined in participants in both groups.
Laboratory analyses will be performed on a day when patients (in the intervention and control groups) are not attending the dialysis procedure and under fasting conditions of at least 8 hours, on any of the three days prior to the start of the exercise sessions. This procedure will be repeated within the three days following the end of the exercise protocol. The control group will be evaluated at the same times as the intervention group.
Measured: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- This study studied in hemodialysis patients the impact of intradialysis exercise on body composition, physical capacity and survival. This clinical trial will be carried out based on the design of groups of HD patients assigned in a randomized manner; The intervention group will receive an intradialysis aerobic exercise and muscular endurance program during the second hour of dialysis, with a frequency of three times a week during; The second group (control group) will not receive intradialytic exercise, although they will receive guidance to carry out a standard treatment, in which they will be recommended to perform aerobic and muscular resistance exercise in their homes at a frequency of three times a week, for 12 weeks .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Jocelyne Piñon Ruiz, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788054
- Sponsor's protocol ID
- CEPIUG-P59-2024
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 12-week Intradialysis Exercise Program on Functional Capacity, Body Composition and Survival in Hemodialysis Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06788054
- Acronym / sponsor ID
- CEPIUG-P59-2024
- Conditions
- Hemodialysis, Kidney Disease, Chronic, Physical Activity, Physical Deconditioning, Physical Function, Survival
- Keywords
- hemodialysis, physical capacity, chronic kidney disease, body composition, intradialysis exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Jan 2025 (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.
Chronic kidney disease and renal replacement treatments (hemodialysis, peritoneal dialysis, kidney transplant) produce various alterations at the level of muscle, bones, fat content and the heart; can alter physical capabilities such as muscle strength, resistance to climb a step repeatedly intensely, and the ability to move the joints freely, in addition to producing an increase or decrease in weight and alterations in its distribution (for example, decreasing muscle and increase fat). The above, added to the particular factors of hemodialysis such as the reduction in daily time to exercise due to the sessions, or the fatigue after it, can together generate greater repercussions on functional capacity and thus increase the risk of suffering from cardiovascular problems. and accelerate the evolution of the disease.
Therefore, this study aims to determine the effect of a 12-week supervised physical exercise program during hemodialysis on strength and ability to move, the amount of fat and muscle in the body, as well as bone wear. ; and compare these results with a group of patients who do not perform supervised exercise. In addition, it will be determined how exercise can act in the long term, preventing the risk of hospitalization and death due to cardiovascular causes. The above is useful in order to establish recommendations and protocols that help us increase the quality of life and survival of the person.
Detailed description
Background: In Mexico, Chronic Kidney Disease (CKD) has a high prevalence and is considered one of the leading causes of death. Hemodialysis (HD) is the primary renal replacement therapy; however, it is associated with significant declines in functional capacity, body composition alterations, morbidity, hospitalization, and mortality with rates that can be 30% higher than those in the general population not on HD. It is estimated that 50% of patients die within the first three years of starting HD, primarily due to cardiovascular complications. Intradialytic exercise has been linked to improvements in functional capacity and metabolic and cardiovascular parameters in HD patients. Despite these benefits, there are few studies examining the relationship between intradialytic physical exercise and increased survival in CKD patients.Objective: To analyze the effects of a 12-week intradialytic exercise program on functional capacity, body composition, and survival in patients undergoing hemodialysis. Hypothesis: A 12-week intradialytic exercise program will improve functional capacity, body composition, and survival rates in hemodialysis patients. Materials and Methods: This clinical trial will utilize a randomized design with two groups of HD patients. The intervention group will participate in an aerobic and muscular resistance exercise program during the second hour of dialysis, three times a week for 12 weeks. The control group will not participate in intradialytic exercise but will receive guidance on standard treatment, including recommendations for aerobic and resistance exercises at home three times a week. All participants (both the intervention and control groups) will be assessed for body composition using bioelectrical impedance analysis, functional capacity through the 6-minute walk test, the 30-second sit-to-stand test, and muscle strength measured by hand dynamometry. The primary outcome variable will be the survival rate at eight months of follow-up after the exercise intervention, and during this time, the International Physical Activity Questionnaire (IPAQ-short version) will be administered every two months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study studied in hemodialysis patients the impact of intradialysis exercise on body composition, physical capacity and survival. This clinical trial will be carried out based on the design of groups of HD patients assigned in a randomized manner; The intervention group will receive an intradialysis aerobic exercise and muscular endurance program during the second hour of dialysis, with a frequency of three times a week during; The second group (control group) will not receive intradialytic exercise, although they will receive guidance to carry out a standard treatment, in which they will be recommended to perform aerobic and muscular resistance exercise in their homes at a frequency of three times a week, for 12 weeks .
| Arm | Type | Receives |
|---|---|---|
| patients with chronic kidney disease on hemodialysis with intradialytic exercise | Experimental | Other: intradialysis exercise |
| patients with chronic kidney disease on hemodialysis without intradialytic exercise | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male and female patients aged between 18-50 years.
- Patients who receive regular hemodialysis sessions 3 times a week, reported through the clinical record.
- Patients with a clinical history of being treated with HD for at least 1 previous year (reported by clinical record).
- Patients without a history of myocardial infarction in the last 3 months (reported by clinical record).
- Patients who are not in a kidney transplant protocol to be performed during the next 12 months.
Key exclusion criteria (6 listed)
- If the patient presents any disease, or neurological, respiratory or skeletal muscle disorder during the development of the physical capacity tests, or during the execution of the protocol, which is aggravated by the practice of physical exercise.
- When the patient voluntarily decides to leave the study.
- When the patient begins additional strength or aerobic training.
- Patients who receive a kidney transplant during the development of the exercise protocol or follow-up during the 8-month follow-up period.
- Patients who decide to belong to the group that will perform intradialytic 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 |
|---|---|---|
| intradialysis exercisemoderate intensity aerobic and muscular resistance exercise protocol lasting 12 weeks | Other | patients with chronic kidney disease on hemodialysis with intradialytic exercise |
Primary outcome
Handgrip strength
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Handgrip strength will be assessed with a dynamometer, which is measured in kilograms (kg). This will be measured on a day without dialysis from the arm without an arteriovenous fistula for patients with a fistula and the dominant hand for patients with a central venous catheter. The test will be performed according to the instructions of the American Society of Hand Therapists, the patient will exert the greatest possible grip strength by flexing the fingers of the hand to the maximum.Three evaluations will be carried out, considering a one-minute rest between each one, and the one in which the patient manages to exert the greatest grip will be taken into account.
Cardiorespiratory capacity
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Cardiorespiratory capacit will be assessed using the 6-minute walk test, which is measured in meters walked. It is a validated assessment tool for exercise capacity in hemodialysis patients. The test will be performed in a hallway 30 meters long, with a flat surface. During the test, the hallway must be free of any other person's traffic. The hallway will have marks at the start and end of the route, and a mark will be placed every three meters to make the count more accurate. In addition, cones will be placed 0.5 meters after the start and 0.5 meters before the end of the route, which will serve as a reference for the participant to make the turn. All participants will be instructed to make as many laps as possible around the hallway, at the highest speed, but always safely (without running). The meters walked (estimated by the number of laps made) by the patient during the 6 minutes will be counted.
Lower limb functionality:
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
It will be evaluated by the 30-Sit to stand test through the number of times the patient "gets up and sits" in the chair for 30 seconds, it is a useful, inexpensive, portable and easy to administer test to assess the strength and functional performance of the lower extremities. A 45 cm high and 61 cm deep steel chair will be placed against the wall and the patient will be positioned sitting in the middle of the chair with his back straight, feet flat on the floor and arms crossed on the chest without leaning on the chair, from this position and at the signal "attention - now" the participant will get up completely and return to the initial position as many times as possible during 30 seconds.
Body Weight
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
body weight (kilograms) will be assessed using a Tanita brand scale, model HD-366.
Height
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Height (centimeters) will be evaluated a Seca brand stadiometer, model 213.
Waist circumference
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Waist circumference (centimeters) with a non-deformable measuring tape (Lufkin W606PM).
Body Mass Index
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
Body mass index (BMI) (kg/m²) will be evaluated dividing the weight in kilograms by the square of the height in meters (BMI = weight [kg]/height [m²]).
Body composition
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
For the evaluation of body composition, the bioelectrical impedance technique will be used using the Inbody brand equipment, model S10. With this equipment, the following parameters will be evaluated: percentage and content of fat mass (grams), fat-free mass (grams), visceral fat area (cm), skeletal muscle mass (grams), total body water (liters). The evaluation will be carried out 30 minutes after the end of the hemodialysis session, on a dialysis day because it is necessary to avoid as much as possible the excess of body water on the day of the evaluation.
1 secondary outcome
Metabolic variables
Time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.
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 22 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradialysis exercise in people with Hemodialysis and Kidney Disease, Chronic, run by Universidad de Guanajuato at 1 site in Mexico.
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 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jan 2025. 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 Mexico. 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?
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?
Handgrip strength (time frame: This test will be measured before starting the intervention with intradialysis exercise and 12 weeks after the start of the same.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.