HealthyNCT06807957
Inspiratory Muscle Training in Amateur CrossFit® Athletes
A study testing Group with IMT and CrossFit® Training in people with Healthy, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The aim of this randomized controlled trial is to investigate the effectiveness of inspiratory muscle training (IMT) on the performance of athletes in CrossFit® activities, respiratory muscle strength, and perceived post-training fatigue. This study follows a two-arm randomized controlled trial protocol. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Group with IMT and CrossFit® Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2026to 30 Mar 2027
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years;
- Be enrolled in a CrossFit® program;
- Be available to perform TMI at home 5 days a week.
Who cannot join
- Have any musculoskeletal, cardiovascular and/or neurological condition that prevents CrossFit® and/or IMT from being performed;
- Be a smoker;
- Not sign the Termo de Consentimento Livre Esclarecido (TCLE);
- Be performing or have performed IMT using linear load equipment in the last month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Academia Compasso - Kapura
Sete Lagoas, Minas Gerais, 35700-007
Mariana P Oliveira, Phd, +55 31 8585-8588, maripaulinoliveira@gmail.com
About this study
Official title: Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength and Physical Performance in Amateur CrossFit® Athletes: A Randomized Controlled Trial
The aim of this randomized controlled trial is to investigate the effectiveness of inspiratory muscle training (IMT) on the performance of athletes in CrossFit® activities, respiratory muscle strength, and perceived post-training fatigue. This study follows a two-arm randomized controlled trial protocol. Ninety-four volunteers aged between 18 and 60 years, enrolled in CrossFit® training, will be randomly allocated to the IMT Group, which involves respiratory training using a linear load device (Powerbreathe®) in conjunction with CrossFit® training; or the Non-IMT Group, which undergoes the same training as the intervention group but uses a device without a valve that ensures resistance. The primary outcome is to investigate the effectiveness of IMT: on maximum inspiratory pressure and maximum expiratory pressure. The secondary outcomes include performance in the six-minute walk test, Pistol, Burpee, Sit-up, Box Jump, Thruster, and Single-Under, burning 25 calories on the "Air Bike" measured by the time taken to reach the 25-calorie mark on this equipment, as well as the assessment of subjective fatigue perception. All outcomes of interest will be collected at baseline and reassessed: mid-term (8 weeks after allocation); and long-term (12 weeks after allocation), the IMT and MEP will be reassessed. Analyses will follow the intention-to-treat principle. Treatment effects will be assessed using Linear Mixed Models. The results of this study may help clarify the effects of IMT on CrossFit® athletes.
Read the detailed description
Study design: This is a prospective randomized controlled trial with two arms. The study was registered with the Research Ethics Committee of the Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM): 81443024.9.0000.5108. Procedures and data collection: Participants who seek the CrossFit® service and enroll, as well as those who are already enrolled, will be invited to participate in this study. All eligible participants will receive information about the study and must sign an informed consent form before participating. The initial assessment and reassessment of the participant will take place at Academia Compasso Sete Lagoas (Boa Vista Unit and/or Centro Unit). The data collected will be: age, height, weight, body mass (BM), Body Mass Index (BMI), heart rate, blood pressure, gender, smoking history (yes/no), medications in use, time practicing the sport and the presence of any comorbidities. All outcomes of interest (respiratory muscle strength, subjective perception of fatigue and results obtained in CrossFit® exercises) will be collected at baseline and reassessed at the following time points: medium term (8 weeks after allocation) and long term (12 weeks after allocation), in an assessment room at the gym. The collected data will initially be entered into a standardized data collection form and then transferred to an Excel table.
The evaluation process will be divided as follows: first, the participant will complete the evaluation form, and then their MIP and MEP values will be collected. Next, the first evaluation test will be performed: "Air Bike" (25 calories); then the evaluation sequence will be performed: Sit-up, Pistol, Burpee, Box Jump, 6MWT, Thruster, and Single-Under. Additionally, after completing all the exercises on the second day of evaluation, the Borg Scale will be administered.
The randomization sequence for the experimental and control groups, with an allocation ratio of 1:1, will be generated by a computer program by one of the researchers who will not be involved in the recruitment of participants. The groups will be coded and the allocation will be transferred to a series of sealed and sequentially numbered opaque envelopes. Two evaluators participated in this stage of the research: researcher 1 will be responsible for the evaluations; and researcher 2 for randomization and distribution of equipment.
Group with TMI: CrossFit® training: participants will be guided and encouraged to attend at least 5 days of training. TMI: the device used for the intervention will be the POWERbreathe®. The load used will be 50% of MIP. The TMI will be performed in two series of 30 breaths through the mouth through the mouthpiece connected to the POWERbreathe®, with a 1-minute interval between series.
Group without TMI: participants allocated to the "No TMI Group" will receive the same interventions as the "Group with TMI", but without the respiratory training included. In addition, they will also perform the TMI in a simulated manner.
- Conditions
- Healthy
- Being tested
- Group with IMT, CrossFit® Training
- Keywords
- Sport, Athlete, Respiratory muscles, CrossFit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group with IMTDevice
Group with IMT + CrossFit training
CrossFit® TrainingBehavioural
The training routine will occur seven days a week, with participants encouraged and motivated to attend at least five training sessions. CrossFit® classes will include: warm-up exercises, strength training (with a focus on Olympic weightlifting and free weights), strength endurance (body weight and external loads), aerobic capacity (across multiple domains), maximal aerobic power (across multiple domains), anaerobic capacity (across multiple domains), cool-down activities, and mobility exercises. Each training session will be designed and supervised by a team of certified physical educators.
| Study group | Role | What they receive |
|---|---|---|
| Group with IMT | Experimental | CrossFit® Training: ParticipaIMT: The intervention will utilize the POWERbreathe® device. Participants will be provided with the device for home training. The model selected for this study is the POWERbreathe® Classic Medium Resistance (Fitness).
The load will be set at 50% of each participant's MIP, as determined during the assessment phase using a vacuum manometer. IMT will be performed in two sets of 30 breaths through a mouthpiece connected to the POWERbreathe®, with a one-minute rest between sets. Participants will complete the training five days per week at home over the course of eight weeks. Additionally, participants will monitor their adherence by completing a log sheet to mark training days. To ensure proper use and management of the device, each participant will receive individual training after randomization. At the end of the eight weeks, participants will return the equipment to the research team for cleaning and redistribution to another participant in the same group. Receives: Device: Group with IMT; Behavioral: CrossFit® Training |
| Group without IMT | Placebo comparator | Group without IMT Participants allocated to the "No IMT Group" will receive the same interventions as the "IMT Group," except for respiratory training. These participants will continue attending CrossFit® training sessions at the gym. They will also perform a simulated IMT, using a device without the valve that generates resistance to the respiratory muscles. Receives: Behavioral: CrossFit® Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength (Maximum inspiratory pressure (MIP)
Respiratory muscle strength (Maximum inspiratory pressure (MIP) Description: The assessment of the strength of the resistant muscles will be performed using a vacuum manometer with an operating range of ± 300 cmH2O. To measure the MIP, the participant must exhale until reaching their Residual Volume (RV), immediately connecting the mouthpiece to the oral tract and making a maximum inspiratory effort against the occluded airway, holding for at least one second.
Measured: at 8 weeks and 12 weeks
Respiratory muscle strength (Maximum expiratory pressure (MEP))
The assessment of the strength of the resistant muscles will be performed using a manovacuometer with an operating range of ± 300 cmH2O. To measure MEP, the participant must inhale until reaching their Total Lung Capacity and then, inserting the mouthpiece into the oral cavity, perform a maximum expiratory effort against the occluded airway, which must be maintained for at least one second.
Measured: at 8 and 12 weeks
Secondary outcomes (9)
Subjective perception of effort
At the end of the exercises on the second day of evaluation, study participants must respond/quantify their perception of effort after training - using the Borg's Perceived Exertion Scale (Scale Borg / 6 - 20). The higher the score, the greater the feeling of effort
Measured: at 8 weeks
6-minute walk test (6MWT)
The 6MWT is a commonly used test for objective assessment of functional exercise capacity. In this relatively low complexity test, the patient is asked to walk as far as possible along a 30 m corridor for a period of 6 minutes, with the primary outcome being the walking distance during the 6 minutes
Measured: at 8 weeks
Box Jump
Standardization of 60 repetitions with timed timing. Height for male population: 60 centimeters (cm); Height for female population: 50 cm
Measured: at 8 weeks
Sit Up
Maximum repetitions in a 2-minute period. In the starting position, the participant will have their back straight and lying on the floor. The hands should be touching the floor behind the head and the legs should be in the "Butterfly" position. The participant should raise the torso, flexing the spine, lifting the shoulders off the floor, until the hands touch the floor with the feet. Then, the upper part of the body should return to the starting position. The participant should perform as many movements as possible within a time of 2 minutes, with the number of repetitions recorded.
Measured: at 8 weeks
Burpee
Maximum repetitions in a 2-minute period. Initially, the participant will be in an upright position, then he/she must perform a squat with his/her hands on the floor. After that, he/she must extend his/her elbows and push his/her legs back, keeping his/her hands in the same place, to get into a plank position. Then, a full push-up must be performed. With another small jump, the participant must return to the position of step 2, with his/her hands and feet on the floor. Finally, use all his/her strength and momentum to perform a vertical jump. The participant must perform as many repetitions as possible in a maximum period of 2 minutes, with the number of repetitions recorded
Measured: at 8 weeks
Pistol
Maximum repetitions in a 2-minute period. The participant must perform as many repetitions of the movement as possible with the right and/or left leg in a maximum of 2 minutes. Standing with arms extended forward, the participant must extend one leg forward. The leg that will remain in support will perform the squat movement, keeping the other leg always extended. The abdomen must remain contracted and the leg extended throughout the squat movement. The torso must lean forward, while the hips are positioned backward. The knee must always be forward, in the direction of the toes. After the squat, return to the starting position.
Measured: at 8 weeks
Single-Under
Standardization of 200 jumps with timed timing.
Measured: at 8 weeks
Thruster
20 repetitions with timed exercise. Men's load: 95lb - 25lb on each side; Women's load: 65lb - 15lb on each side
Measured: at 8 weeks
Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike
Before starting the test, the evaluator will adjust the seat to hip height and ensure that each participant's arms can comfortably reach the handles. The participant must then perform synchronous movements of the upper and lower limbs until reaching the 25-calorie mark
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study startJan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- The randomization sequence for the experimental and control groups, with a 1:1 allocation ratio, will be generated by computer software by one of the researchers who will not be involved in participant recruitment. The groups will be coded, and the allocation will be transferred to a series of sequentially numbered, sealed, opaque envelopes.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807957
- Sponsor's protocol ID
- 81443024.9.0000.5108
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the publication of results. These data will be available in the database: Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength and Physical Performance in Amateur CrossFit® Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06807957
- Acronym / sponsor ID
- 81443024.9.0000.5108
- Conditions
- Healthy
- Keywords
- Sport, Athlete, Respiratory muscles, CrossFit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 4 Feb 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.
The aim of this randomized controlled trial is to investigate the effectiveness of inspiratory muscle training (IMT) on the performance of athletes in CrossFit® activities, respiratory muscle strength, and perceived post-training fatigue. This study follows a two-arm randomized controlled trial protocol. Ninety-four volunteers aged between 18 and 60 years, enrolled in CrossFit® training, will be randomly allocated to the IMT Group, which involves respiratory training using a linear load device (Powerbreathe®) in conjunction with CrossFit® training; or the Non-IMT Group, which undergoes the same training as the intervention group but uses a device without a valve that ensures resistance. The primary outcome is to investigate the effectiveness of IMT: on maximum inspiratory pressure and maximum expiratory pressure. The secondary outcomes include performance in the six-minute walk test, Pistol, Burpee, Sit-up, Box Jump, Thruster, and Single-Under, burning 25 calories on the "Air Bike" measured by the time taken to reach the 25-calorie mark on this equipment, as well as the assessment of subjective fatigue perception. All outcomes of interest will be collected at baseline and reassessed: mid-term (8 weeks after allocation); and long-term (12 weeks after allocation), the IMT and MEP will be reassessed. Analyses will follow the intention-to-treat principle. Treatment effects will be assessed using Linear Mixed Models. The results of this study may help clarify the effects of IMT on CrossFit® athletes.
Detailed description
Study design: This is a prospective randomized controlled trial with two arms. The study was registered with the Research Ethics Committee of the Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM): 81443024.9.0000.5108. Procedures and data collection: Participants who seek the CrossFit® service and enroll, as well as those who are already enrolled, will be invited to participate in this study. All eligible participants will receive information about the study and must sign an informed consent form before participating. The initial assessment and reassessment of the participant will take place at Academia Compasso Sete Lagoas (Boa Vista Unit and/or Centro Unit). The data collected will be: age, height, weight, body mass (BM), Body Mass Index (BMI), heart rate, blood pressure, gender, smoking history (yes/no), medications in use, time practicing the sport and the presence of any comorbidities. All outcomes of interest (respiratory muscle strength, subjective perception of fatigue and results obtained in CrossFit® exercises) will be collected at baseline and reassessed at the following time points: medium term (8 weeks after allocation) and long term (12 weeks after allocation), in an assessment room at the gym. The collected data will initially be entered into a standardized data collection form and then transferred to an Excel table.
The evaluation process will be divided as follows: first, the participant will complete the evaluation form, and then their MIP and MEP values will be collected. Next, the first evaluation test will be performed: "Air Bike" (25 calories); then the evaluation sequence will be performed: Sit-up, Pistol, Burpee, Box Jump, 6MWT, Thruster, and Single-Under. Additionally, after completing all the exercises on the second day of evaluation, the Borg Scale will be administered.
The randomization sequence for the experimental and control groups, with an allocation ratio of 1:1, will be generated by a computer program by one of the researchers who will not be involved in the recruitment of participants. The groups will be coded and the allocation will be transferred to a series of sealed and sequentially numbered opaque envelopes. Two evaluators participated in this stage of the research: researcher 1 will be responsible for the evaluations; and researcher 2 for randomization and distribution of equipment.
Group with TMI: CrossFit® training: participants will be guided and encouraged to attend at least 5 days of training. TMI: the device used for the intervention will be the POWERbreathe®. The load used will be 50% of MIP. The TMI will be performed in two series of 30 breaths through the mouth through the mouthpiece connected to the POWERbreathe®, with a 1-minute interval between series.
Group without TMI: participants allocated to the "No TMI Group" will receive the same interventions as the "Group with TMI", but without the respiratory training included. In addition, they will also perform the TMI in a simulated manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The randomization sequence for the experimental and control groups, with a 1:1 allocation ratio, will be generated by computer software by one of the researchers who will not be involved in participant recruitment. The groups will be coded, and the allocation will be transferred to a series of sequentially numbered, sealed, opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Group with IMT | Experimental | Device: Group with IMT, Behavioral: CrossFit® TrainingCrossFit® Training: ParticipaIMT: The intervention will utilize the POWERbreathe® device. Participants will be provided with the device for home training. The model selected for this study is the POWERbreathe® Classic Medium Resistance (Fitness). The load will be set at 50% of each participant's MIP, as determined during the assessment phase using a vacuum manometer. IMT will be performed in two sets of 30 breaths through a mouthpiece connected to the POWERbreathe®, with a one-minute rest between sets. Participants will complete the training five days per week at home over the course of eight weeks. Additionally, participants will monitor their adherence by completing a log sheet to mark training days. To ensure proper use and management of the device, each participant will receive individual training after randomization. At the end of the eight weeks, participants will return the equipment to the research team for cleaning and redistribution to another participant in the same group. |
| Group without IMT | Placebo comparator | Behavioral: CrossFit® TrainingGroup without IMT Participants allocated to the "No IMT Group" will receive the same interventions as the "IMT Group," except for respiratory training. These participants will continue attending CrossFit® training sessions at the gym. They will also perform a simulated IMT, using a device without the valve that generates resistance to the respiratory muscles. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years;
- Be enrolled in a CrossFit® program;
- Be available to perform TMI at home 5 days a week.
Key exclusion criteria (4 listed)
- Have any musculoskeletal, cardiovascular and/or neurological condition that prevents CrossFit® and/or IMT from being performed;
- Be a smoker;
- Not sign the Termo de Consentimento Livre Esclarecido (TCLE);
- Be performing or have performed IMT using linear load equipment in the last month.
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 |
|---|---|---|
| Group with IMTGroup with IMT + CrossFit training | Device | Group with IMT |
| CrossFit® TrainingThe training routine will occur seven days a week, with participants encouraged and motivated to attend at least five training sessions. CrossFit® classes will include: warm-up exercises, strength training (with a focus on Olympic weightlifting and free weights), strength endurance (body weight and external loads), aerobic capacity (across multiple domains), maximal aerobic power (across multiple domains), anaerobic capacity (across multiple domains), cool-down activities, and mobility exercises. Each training session will be designed and supervised by a team of certified physical educators. | Behavioural | Group with IMT, Group without IMT |
Primary outcome
Respiratory muscle strength (Maximum inspiratory pressure (MIP)
Time frame: at 8 weeks and 12 weeks
Respiratory muscle strength (Maximum inspiratory pressure (MIP) Description: The assessment of the strength of the resistant muscles will be performed using a vacuum manometer with an operating range of ± 300 cmH2O. To measure the MIP, the participant must exhale until reaching their Residual Volume (RV), immediately connecting the mouthpiece to the oral tract and making a maximum inspiratory effort against the occluded airway, holding for at least one second.
Respiratory muscle strength (Maximum expiratory pressure (MEP))
Time frame: at 8 and 12 weeks
The assessment of the strength of the resistant muscles will be performed using a manovacuometer with an operating range of ± 300 cmH2O. To measure MEP, the participant must inhale until reaching their Total Lung Capacity and then, inserting the mouthpiece into the oral cavity, perform a maximum expiratory effort against the occluded airway, which must be maintained for at least one second.
9 secondary outcomes
Subjective perception of effort
Time frame: at 8 weeks
6-minute walk test (6MWT)
Time frame: at 8 weeks
Box Jump
Time frame: at 8 weeks
Sit Up
Time frame: at 8 weeks
Burpee
Time frame: at 8 weeks
Pistol
Time frame: at 8 weeks
Single-Under
Time frame: at 8 weeks
Thruster
Time frame: at 8 weeks
Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike
Time frame: at 8 weeks
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 27 Jan 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the publication of results. These data will be available in the database: Open Science Framework
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group with IMT and CrossFit® Training in people with Healthy, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 3 inclusion and 4 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 27 Jan 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 Brazil. 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. Some participants in this study may receive a placebo. 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 Diego M Xavier, PhD student (+55 31 997106999, diegomendesxav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (Maximum inspiratory pressure (MIP) (time frame: at 8 weeks and 12 weeks). 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?
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 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.