Age-Related SarcopeniaNCT05542758
High-Intensity Interval Training for Older Adults
A study testing Total Body HIIT Program in people with Age-Related Sarcopenia, run by Creighton University at 1 site in United States.
Trial summary
This study will examine differences in a 12 week high-intensity interval training regimen. The Total Body HIIT program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Sarcopenia
- What is being tested?
- Total Body HIIT Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Dec 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-95 years of age or older
- Physical independent (Barthel Index)
- Physician clearance to participate
- No medication changes in previous 30 days
- No structured resistance training program in previous 6 months
Who cannot join
- Contraindications to high-intensity exercise39 (PAR-Q Questionnaire)
- Severe mental impairment (<18 on Montreal Cognitive Assessment)
- Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Intensity Interval Training: Impacts on Function, Neuromuscular Control, and Muscle Architecture
This study will examine differences in a 12 week high-intensity interval training regimen. The Total Body HIIT program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. The specific objectives focus on examining cardiovascular endurance, neuromuscular function, and muscle architecture.
- Conditions
- Age-Related Sarcopenia
- Being tested
- Total Body HIIT Program
- Keywords
- geriatrics, high-intensity interval training, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Body HIIT ProgramOther
One repetition maximums (1RM) and body weight (BW) will be recorded at prior to and at 6 weeks to tailor the program. The circuit will be completed twice during each session and the exercises will include: squats, medicine ball forward chest throws, medicine ball overhead throw, farmers walk, seated shoulder press, seated row sitting on a fitness ball, aerobic riser step-ups, foot ladder drills, and twisting medicine ball passes. The anaerobic component will be completed once during a session and on a stationary bike. The progression of exercise:rest seconds will be 20:40 for Weeks 1-4, 30:30 for Weeks 5-8, and 40:20 for Weeks 9-12. Each session will start with a 5 minute warm up and end with a 5-minute cool down. Participants will be given real time feedback about heart rate (goal range: 85-95% HRmax) and exercise movement velocity. Participants will be encouraged to surpass the velocity of the previous repetition.
| Study group | Role | What they receive |
|---|---|---|
| Total Body HIIT Program | Experimental | This Total Body HIIT program (circuit and bike training) will involve 3 sessions per week (35-40 min on nonconsecutive days) progressed across the 12 weeks. All session will be lead by undergraduate exercise science students or doctor of physical therapy students and supervised by a physical therapist. Receives: Other: Total Body HIIT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Min Walk Test performance from baseline to following HIIT intervention
The 6MWT will be assessed by tallying the number of laps a participant is able walk on a 100 ft straight path. Partially completed laps will be measured and added to the total distance. Participants will be allowed to take standing rest breaks, if necessary, but the time will continue during all rest breaks. Participants will be instructed to "cover as much ground as you can in 6 minutes".
Measured: change from baseline to immediately after the HIIT intervention
Change in Voluntary Muscle Strength Tests (Isokinetics) from baseline to following HIIT intervention
Isokinetic strength testing on the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles at slow (60° per second), medium (180° per second), fast (300° per second) and fast unweighted (500° per second) speeds with three maximal repetitions performed for each speed to determine voluntary peak torque production capabilities at each speed using a dynamometer. During the strength testing assessments, each subject will be asked to push or pull "as hard as possible" against a lever arm on the dynamometer until the limb reaches the end of the range of motion.
Measured: change from baseline to immediately after the HIIT intervention
Change in Voluntary Muscle Strength Tests (Isometrics) from baseline to following HIIT intervention
Isometric strength of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles will be assessed using a dynamometer. For maximal voluntary isometric contraction assessments, participants will complete two, 3- to 4-second MVICs of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii. Participants will be instructed to "push or pull as hard and fast as possible" and hold against the dynamometer to achieve max voluntary torque and rate of torque development.
Measured: change from baseline to immediately after the HIIT intervention
Change in Evoked Muscle Function Assessments: Evoked Peak Force from baseline to following HIIT intervention
Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, torque produced from the quadriceps femoris from the dynamometer during the first 50 ms, evoked peak force.
Measured: change from baseline to immediately after the HIIT intervention
Change in Evoked Muscle Function Assessments: Evoked Peak Rate of Force Development from baseline to following HIIT intervention
Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, evoked peak rate of force development 0-50ms will be recorded resulting from a maximal doublet stimulus from the quadriceps femoris.
Measured: change from baseline to immediately after the HIIT intervention
Change in Rate of Muscle Activation from baseline to following HIIT intervention
To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Rate of muscle activation will be assessed in the first 50 ms following muscle activation onset.
Measured: change from baseline to immediately after the HIIT intervention
Change in Voluntary Electromechanical Delay from baseline to following HIIT intervention
To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Voluntary electromechanical delay will be calculated from the time difference from the onset of sEMG to the onset of force.
Measured: change from baseline to immediately after the HIIT intervention
Change in Ultrasound-based Muscle Architecture: Cross-sectional Area from baseline to following HIIT intervention
Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Muscle cross-sectional area for each muscle will be assessed.
Measured: change from baseline to immediately after the HIIT intervention
Change in Ultrasound-based Muscle Architecture: Echo Intensity from baseline to following HIIT intervention
Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Echo intensity for each muscle will be assessed.
Measured: change from baseline to immediately after the HIIT intervention
Change in Muscle Biopsy-based Muscle Architecture from baseline to following HIIT intervention
Muscle biopsies will be collected to determine myofiber size from the quadriceps femoris (i.e., vastus lateralis). After necessary biopsy preparations, the distribution of myofiber type and size will be determined within each sample.
Measured: change from baseline to immediately after the HIIT intervention
Secondary outcomes (8)
Change in V02 peak from baseline to following HIIT intervention
Participants will complete a graded exercise test (2-min stages) on the cycle ergometer to evaluate VO2 peak. VO2 peak for each subject will be taken as the highest single VO2 value when at least two of the three following test criteria are satisfied: 1) A leveling off in VO2 despite an increase in power output, 2) maximal heart rate within 15 beats of age-predicted maximal heart rate (220-age), and 3) respiratory exchange ratio (RER) ≥1.1.
Measured: change from baseline to immediately after the HIIT intervention
Change in Gait Speed from baseline to following HIIT intervention
Gait speed will be assessed with the 10-meter walk test (maximum comfortable walking speed).
Measured: change from baseline to immediately after the HIIT intervention
Change in Functional Lower Body Strength from baseline to following HIIT intervention
Functional lower body strength will be assessed with the 5 times sit to stand test. This test requires participants to stand up and sit down 5 times without the use of upper extremities as fast as possible.
Measured: change from baseline to immediately after the HIIT intervention
Change in Functional Upper Body Strength from baseline to following HIIT intervention
Functional upper body strength will be assessed with hand grip strength. Three repetitions of 30 second maximum hold on each hand will be completed.
Measured: change from baseline to immediately after the HIIT intervention
Change in Balance: Center of Pressure Excursion from baseline to following HIIT intervention
Participants will statically stand on a force plate in three different scenarios (feet together eyes open, feet together eyes shut, and single-leg stance). Center of pressure excursion will be calculated to determine static balance.
Measured: change from baseline to immediately after the HIIT intervention
Change in Balance: Functional Gait Assessment from baseline to following HIIT intervention
Participants will complete the functional gait assessment, a clinical assessment of walking ability under various conditions (e.g., stepping over an obstacle, walking backwards, etc.). Scores range from 0-30 with higher scores indicating better balance performance.
Measured: change from baseline to immediately after the HIIT intervention
Change in Balance: Berg Balance Scale from baseline to following HIIT intervention
Participants will complete the Berg Balance Scale, a clinical assessment of static and dynamic balance abilities. The Berg Balance Scale Score ranges from 0-56 with higher scores indicating better balance performance.
Measured: change from baseline to immediately after the HIIT intervention
Change in Health-Related Quality of Life from baseline to following HIIT intervention
Participants will complete the Short-Form Health Survey (SF-36) to assess health-related quality of life.
Measured: change from baseline to immediately after the HIIT intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related SarcopeniaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the 12-week high-intensity intervention.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542758
- Sponsor's protocol ID
- 2003313
- Status last verified
- Jul 2024
- First submitted
- 6 Sep 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be determined on a request case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training: Impacts on Function, Neuromuscular Control, and Muscle Architecture
- ClinicalTrials.gov ID
- NCT05542758
- Acronym / sponsor ID
- 2003313
- Conditions
- Age-Related Sarcopenia
- Keywords
- geriatrics, high-intensity interval training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Sep 2022 (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.
This study will examine differences in a 12 week high-intensity interval training regimen. The Total Body HIIT program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. The specific objectives focus on examining cardiovascular endurance, neuromuscular function, and muscle architecture.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the 12-week high-intensity intervention.
| Arm | Type | Receives |
|---|---|---|
| Total Body HIIT Program | Experimental | Other: Total Body HIIT ProgramThis Total Body HIIT program (circuit and bike training) will involve 3 sessions per week (35-40 min on nonconsecutive days) progressed across the 12 weeks. All session will be lead by undergraduate exercise science students or doctor of physical therapy students and supervised by a physical therapist. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65-95 years of age or older
- Physical independent (Barthel Index)
- Physician clearance to participate
- No medication changes in previous 30 days
- No structured resistance training program in previous 6 months
Key exclusion criteria (3 listed)
- Contraindications to high-intensity exercise39 (PAR-Q Questionnaire)
- Severe mental impairment (<18 on Montreal Cognitive Assessment)
- Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
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 |
|---|---|---|
| Total Body HIIT ProgramOne repetition maximums (1RM) and body weight (BW) will be recorded at prior to and at 6 weeks to tailor the program. The circuit will be completed twice during each session and the exercises will include: squats, medicine ball forward chest throws, medicine ball overhead throw, farmers walk, seated shoulder press, seated row sitting on a fitness ball, aerobic riser step-ups, foot ladder drills, and twisting medicine ball passes. The anaerobic component will be completed once during a session and on a stationary bike. The progression of exercise:rest seconds will be 20:40 for Weeks 1-4, 30:30 for Weeks 5-8, and 40:20 for Weeks 9-12. Each session will start with a 5 minute warm up and end with a 5-minute cool down. Participants will be given real time feedback about heart rate (goal range: 85-95% HRmax) and exercise movement velocity. Participants will be encouraged to surpass the velocity of the previous repetition. | Other | Total Body HIIT Program |
Primary outcome
Change in 6-Min Walk Test performance from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
The 6MWT will be assessed by tallying the number of laps a participant is able walk on a 100 ft straight path. Partially completed laps will be measured and added to the total distance. Participants will be allowed to take standing rest breaks, if necessary, but the time will continue during all rest breaks. Participants will be instructed to "cover as much ground as you can in 6 minutes".
Change in Voluntary Muscle Strength Tests (Isokinetics) from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Isokinetic strength testing on the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles at slow (60° per second), medium (180° per second), fast (300° per second) and fast unweighted (500° per second) speeds with three maximal repetitions performed for each speed to determine voluntary peak torque production capabilities at each speed using a dynamometer. During the strength testing assessments, each subject will be asked to push or pull "as hard as possible" against a lever arm on the dynamometer until the limb reaches the end of the range of motion.
Change in Voluntary Muscle Strength Tests (Isometrics) from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Isometric strength of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii muscles will be assessed using a dynamometer. For maximal voluntary isometric contraction assessments, participants will complete two, 3- to 4-second MVICs of the hamstrings, quadriceps femoris, biceps brachii, and triceps brachii. Participants will be instructed to "push or pull as hard and fast as possible" and hold against the dynamometer to achieve max voluntary torque and rate of torque development.
Change in Evoked Muscle Function Assessments: Evoked Peak Force from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, torque produced from the quadriceps femoris from the dynamometer during the first 50 ms, evoked peak force.
Change in Evoked Muscle Function Assessments: Evoked Peak Rate of Force Development from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Evoked muscle function will be assessed using electrical stimulation delivered to the superficial quadriceps femoris via a cathode-anode arrangement, with the cathode probe pressed into the femoral triangle over the femoral nerve and the anode fixed over the greater trochanter. Manual stepwise increases in stimulation will be completed until max contraction is achieved. Once max contraction is achieved, a maximal, single and doublet stimulus will be administered. The single stimulation will be used to elicit a max M-wave amplitude (defined as the max M-wave peak-to-peak amplitude). A doublet stimulus will be used to drive the muscle to maximal contraction capability to investigate the muscle contractile capability. To examine maximal contractile capacity, evoked peak rate of force development 0-50ms will be recorded resulting from a maximal doublet stimulus from the quadriceps femoris.
Change in Rate of Muscle Activation from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Rate of muscle activation will be assessed in the first 50 ms following muscle activation onset.
Change in Voluntary Electromechanical Delay from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
To examine muscle activation, surface electromyographic (sEMG) signals collected during the voluntary and evoked muscle contractions will be collected from the quadriceps femoris (vastus lateralis, rectus femoris, and vastus medialis muscles), hamstrings (biceps femoris muscle), biceps brachii, and triceps brachii muscles. Peak muscle activation will be assessed as the peak sEMG amplitude. Voluntary electromechanical delay will be calculated from the time difference from the onset of sEMG to the onset of force.
Change in Ultrasound-based Muscle Architecture: Cross-sectional Area from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Muscle cross-sectional area for each muscle will be assessed.
Change in Ultrasound-based Muscle Architecture: Echo Intensity from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Ultrasound images of the vastus lateralis, rectus femoris, biceps femoris, vastus medialis, biceps brachii, and triceps brachii will be obtained. Echo intensity for each muscle will be assessed.
Change in Muscle Biopsy-based Muscle Architecture from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Muscle biopsies will be collected to determine myofiber size from the quadriceps femoris (i.e., vastus lateralis). After necessary biopsy preparations, the distribution of myofiber type and size will be determined within each sample.
8 secondary outcomes
Change in V02 peak from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Gait Speed from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Functional Lower Body Strength from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Functional Upper Body Strength from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Balance: Center of Pressure Excursion from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Balance: Functional Gait Assessment from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Balance: Berg Balance Scale from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Change in Health-Related Quality of Life from baseline to following HIIT intervention
Time frame: change from baseline to immediately after the HIIT intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided. Data sharing will be determined on a request case-by-case basis.
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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.
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 Total Body HIIT Program in people with Age-Related Sarcopenia, run by Creighton University at 1 site in United States.
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 5 inclusion and 3 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 16 Jul 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 United States. 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?
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?
Change in 6-Min Walk Test performance from baseline to following HIIT intervention (time frame: change from baseline to immediately after the HIIT intervention). The study lists 10 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 16 Jul 2024.