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Physical ActivityHEATNCT04286919

Comparing Two Different Methods to Prescribe Exercise

A study of Physical Activity and Health Behavior, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Practical interventions are needed to increase physical activity (PA) levels in insufficiently active individuals. HEAT is a randomized controlled trial comparing two different exercise prescription (ExRx) methods to increase PA volume among insufficiently active UConn students. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity, Health Behavior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
22 Feb 2019to 28 May 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >18 years old.
  • Participants will attend UConn Storrs campus as an undergraduate or graduate student during the study.
  • Participants must be physically inactive as defined by participating in less than or equal to 2 days of planned, structured physical activity over the past 12 weeks.
  • Any and all races may be included.
  • Participants will be healthy with no diagnosed cardiovascular, pulmonary, metabolic, or other chronic diseases or depression and not taking medication for any of these chronic diseases or health conditions as defined by answering "no" to all General Health Questions listed in the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
  • Anyone scoring less than a 19 on the Beck Depression Inventory.
Show all 16Show fewer
  • Those who answer "yes" to 3 or less on the eating questionnaire will be included.
  • Between 18-35 m2/kg.
  • Participants should be non-smokers for at least 6 months prior to entry.
  • Participants should drink <2 alcoholic drinks daily.
  • Women who are not pregnant or lactating and do not plan on becoming pregnant.
  • Participants with no arthritis or orthopedic problems inhibiting their ability to exercise across all intensities without exacerbating the problem.
  • Participants willing to maintain their habitual diet throughout the study.
  • Participants wanting to enter the study for reasons that do not include weight loss.
  • Participants should be willing and able to consent to all data collection processes including the intended timeline of the study procedures as well as all questionnaires, fitness assessments, and physical activity monitor usage.
  • Participants who are willing to use only the physical activity program given to them by researchers and are willing to refrain from obtaining and using another program given to them by anyone else besides study researchers. Participants must also agree to not look at the physical activity guidelines being administered to the other intervention group that they are not assigned to.

Who cannot join

  • <18 years old
  • Not attending UConn Storrs campus during the duration of their enrollment.
  • Answering "no" to any question on the 12-item checklist of inclusion criteria
  • Participating in more than 2 days of planned, structured physical activity over the past 12 weeks.
  • Unhealthy students as determined by answering "yes" to any question listed on the PAR-Q+.
  • Scoring a 19 or higher on the Beck Depression Inventory.
Show all 16Show fewer
  • Those who answer "yes" to more than 3 statements on the SCOFF eating disorder questionnaire will be excluded.
  • BMI <18 or >35 m2/kg.
  • People who currently smoke, plan on smoking or have smoked tobacco within the last 6 months.
  • People drinking 2 or more alcoholic drinks daily.
  • Women who are pregnant or lactating.
  • People with arthritis or orthopedic problems will not be enrolled if these conditions compromise their completion of the exercise protocols or ability to exercise across all intensities.
  • People unwilling to maintain their habitual diet as we request throughout study participation.
  • We will not recruit subjects whose primary motivation for enrolling is to lose weight.
  • People who do not think they will be able to complete all study protocols at the times they are scheduled to complete them. This includes the completion of study time logs and all study visits.
  • Anyone not willing to confirm that they will refrain from obtaining another exercise program or viewing that of the other group.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Connecticut

    Storrs, Connecticut, 06268

Other trials in United States

About this study

Official title: The Heat Is On To Increase Physical Activity: Comparing Two Different Methods To Prescribe Exercise

Practical interventions are needed to increase physical activity (PA) levels in insufficiently active individuals. HEAT is a randomized controlled trial comparing two different exercise prescription (ExRx) methods to increase PA volume among insufficiently active UConn students. Students will be randomized to two groups: (1) ExRx#1 will emphasize meeting the Physical Activity Guidelines for Americans via the Frequency, Intensity, Time, and Type or FITT principle of ExRx; and (2) ExRx#2 will be founded in the Integrated Behavior Change Theory and based on the 2018 Physical Activity Guidelines Review Committee Scientific Report heat map which emphasizes that all PA counts. HEAT aims to assess the effectiveness of each ExRx individually and comparatively to one another for each outcome measure. We hypothesize that UConn students in ExRx#2 will increase PA volume more than ExRx#1 in response to the 12wk ExRx due to its foundation in the IBC. If our hypothesis proves correct we aim to inform healthcare providers on university campuses on which method of ExRx is more effective at increasing PA participation among their insufficiently active students.

Read the detailed description

Being regularly physically active, defined as exercising at least 3-days/wk for 30-min provides essential and seemingly unlimited health benefits. To emphasize the importance of the health benefits of physical activity (PA), the United States government recently provided us with The Physical Activity Guidelines for Americans (PAG) 2nd edition. This recommended PA prescription for improving and maintaining health includes 150-min/wk of moderate intensity aerobic PA plus 2-days of muscle-strengthening PA. Yet, an estimated 26% of American adults and 36% of college students do not perform any leisure-time PA. A novelty of the PAG 2nd edition is the updated research acknowledging that PA exists on a spectrum where any and all movement is beneficial to health. This update emphasizes that the steepest decrease in relative risk of all-cause mortality among physically inactive individuals occurs with the substitution of sedentary behavior for light intensity movement, inherently encompassing lifestyle activities as healthy, meaningful PA. The 2018 Physical Activity Guidelines Advisory Committee Scientific Report (PAGACSR) conceptualizes this important public health message with the creation of a heat map relating PA with all-cause mortality, creatively depicting the dose-response effect of increased PA on health. The Office of Disease Prevention and Health Promotion contends that this new emphasis on all PA counting towards health can serve as a method of increasing PA in physically inactive individuals as demonstrated by the launch of the Move Your Way initiative. The all movement counts message can encompass the Integrated Behavior Change Theory (IBC) which attributes increased PA to perceived behavioral control due to higher autonomy.

HEAT is a Randomized Controlled Trial (RCT) comparing the PAG exercise prescription (ExRx#1) of 150-min/wk of moderate intensity aerobic PA plus 2-days of muscle-strengthening PA to a new method of exercise prescription (ExRx) using the everything counts message depicted by the heat map (ExRx#2) to prescribe exercise to physically inactive individuals. ExRx#1 uses the Frequency, Intensity, Time, and Type or FITT principle of ExRx to relay the PAG; and ExRx#2 will be founded in the Integrated Behavior Change Theory (IBC) and emphasize that all PA counts to relay the message of the heat map. ExRx#1 communicates the PAG ultimate weekly goal ExRx using an image adopted from the PAG website that depicts the 150-minutes of aerobic and 2 days of muscle strengthening exercise and provides a weekly prescription on the FITT of how to accomplish this weekly goal. ExRx#2 uses the heat map image to communicate the ExRx of all movement counts and that exercise can be done along any FITT.

Both ExRx were created by an expert panel of exercise professionals including the principal investigator Linda S Pescatello, PhD, who was senior editor of the American College of Sports Medicine Guidelines for Exercise Testing and Prescription 9th edition and one of the 17 Advisory Committee members of the PAGACSR which provided the scientific foundation for the PAG 2nd edition.

  1. ExRx #1: The ExRx given to participants each week represents the ultimate weekly goal of 150-min of aerobic PA plus 2-days of muscle-strengthening PA to support optimal health. For example, the ExRx on week 6 suggests 3-days/wk of 50-min of aerobic PA plus 2-days of 30-min of muscle-strengthening PA in the form of resistance or neuromotor exercise. The ExRx then gives examples of taking a 50-min moderate intensity Zumba class on one day to fulfill part of the weekly aerobic PA guideline and 2-3 sets of 8-12 reps of resistance exercises for 30-min of muscle-strengthening PA on another day.
  2. ExRx #2: The ExRx given to participants each week represents the ultimate weekly goal of moving more throughout the day across all intensities in order to achieve optimal health as represented by the deep green color on the bottom right of the heat map image that represented high amounts of activity and good health. For example, the ExRx on week 6 suggests including a variety of moderate intensity physical activities and light intensity physical activities to achieve the deep green color on the bottom right of the heat map. The ExRx then gives the examples of taking a Zumba class and weight training.

Subjects will be randomly assigned to receiving either ExRx#1 (n=30), or ExRx#2 (n=30). All subjects will participate in a 12-week unsupervised ExRx program that will safely progress them from being physically inactive to becoming physically active. Each week subjects of both groups will be sent an ExRx in the form of PA recommendations for the week that will be matched in terms of intervention setting, behavior change strategies, mode of intervention delivery, suggestions for types of PA to do, action planning, goal timeframe, and feedback. The difference between the two ExRx methods is the messaging of the specific frequency, intensity time, and type to follow in ExRx#1 versus giving only suggestions of exercises to do and no frequency, intensity, time or type restriction as "all movement counts" is emphasized in ExRx#2. Both groups will be given the main goal of the guidelines they are randomized to along with the same information on the definitions of aerobic, resistance, neuromotor, flexibility and concurrent exercise along with how to measure intensity of PA using the talk test and the Borg Ratings of Perceived Exertion 6-20 scale. Each participant will be verbally explained the overall goal of the ExRx and walked through the definitions to ensure complete understanding of each mode of PA and how to monitor intensity of activity. Both groups will be instructed that the guidelines will progress them from being physically inactive to meeting the overall goal of the ExRx from weeks 1-6; then the guidelines will stay consistent in prescribing the overall goal of the ExRx from weeks 6-12. In both groups, the ExRx is described as effective for improving and maintaining health and that all PA participation is at their own discretion and they can do whatever PA type they would like. Participants in both groups will be given the same exercise compendium of aerobic and resistance exercises to choose from in case they are unsatisfied with the example types of PA recommended in the weekly guidelines. Researchers will stress the goal of accurately recording PA and exercise regardless of if the recommendations given to them are met or not.

Currently 36% of University students are physically inactive. Due to barriers such as lack of time, exercising 150-min/wk+ and accomplishing a specific FITT such as the ExRx#1 provides may seem unattainable. In contrast, the ExRx#2 demonstrates a simple message to move more however you can, allowing for practical uptake of increased PA and using the IBC to connect the intention to exercise with the behavior through increased self-efficacy and autonomy. We hypothesize that ExRx #2 will elicit greater increases in PA volume from baseline (BL) to post-test at the end of the 12 weeks of guidelines (12W) compared to ExRx#1. We hypothesize that ExRx#2 will produce greater improvement in autonomy and self-efficacy compared to ExRx#1 at 12W.

Anthropometrics, health-fitness assessments, PA tracking and questionnaires will be administered at BL, 6W and 12W. All questionnaires will be administered in person using Qualtrics Secure encrypted database and will be compared between groups at BL, 6W and 12W to measure changes over time. Age will be assessed in years. Height (cm) and weight (kg) will be measured and used to calculate body mass index in m2/kg. Waist circumference will be measured at the height of the iliac crest with a Gulick tape measure in cm. Cardiorespiratory fitness will be assessed using a modified and validated Harvard Step Test protocol where participants step up and down on a 30cm box at a rate of 30 steps/min for 3-min and recovery heart rate (HR) is recorded. Muscular endurance will be measured via the push-up test with males performing repetitions until failure in the standard position and females in the modified kneeling position. Handgrip strength is a validated measure of overall muscular strength and will be measured using a validated protocol in the dominant hand with the Jamar Hydraulic Handgrip Dynamometer. Flexibility will be measured in cm using a Sit and Reach Flexibility Box. Timeline Follow-Back for Exercise (TLFB-E) is a self-report calendar diary method for logging daily exercise and PA, and sitting and sleeping time. Participants will record daily PA frequency, type, duration (min) and intensity using the Borg 6-20 scale. Researchers will assess the TLFB-E weekly to ensure students are actively participating in reading the ExRx guidelines and logging activity. Paffenbarger Physical Activity Questionnaire Question 8 will measure duration (min) in each intensity of PA plus time spent sleeping and sitting for a typical weekday and weekend day. PA volume will be calculated in MET.min/wk. Actical® accelerometers will be given to participants to wear on their hip for 4 consecutive days including 2 weekdays and 2 weekend days as an objective measure of PA volume in MET.min/day, steps/day and time spent in light, moderate and vigorous intensities. Transtheoretical Model Stage of Change will assess readiness to take action to exercise regularly and measures transitions in this readiness. Motivation for Physical Activity will determine type of motivation for PA (e.g., intrinsic vs external) and self-perceived autonomy. Marcus Self-Efficacy questionnaire will measure confidence for exercising when 5 different perceived barriers present. Task Self-Efficacy will measure confidence for exercising 3 times/wk at increasing durations. Barriers to Self-Efficacy will assess confidence in exercising 3days/wk for the next 3 months in the presence of possible barriers to exercise.

Group descriptive statistics will be presented as mean±standard deviation and ANOVA will be performed to determine if there are BL differences between the groups. All BL, 6W and 12W measures of PA and the psychosocial questionnaires will be analyzed with repeated measures ANCOVA using gender as a fixed factor and age, BMI, WC and other baseline descriptive characteristics as possible covariates. Post-hoc analyses will be used to test differences in groups and for 3 time points if there are significant time, group or time*group interactions. Methods such as multiple imputation and estimated means algorithm will be used to carry out statistical inferences in the presence of missing data. All analyses will be set at the alpha level of .05 and will be carried out using SPSS Version 25.

ExRx #1 utilizes the widely-used gold standard FITT principle of ExRx to promote achieving the PAG. ExRx #2 uses updated research on the benefits of light intensity movement and the all movement counts message founded in the IBC to inherently support autonomy and higher self-efficacy to connect the intention to exercise with the behavior. This RCT will inform practitioners about which message resonates more with physically inactive students so we can more effectively promote healthy, active lifestyles.

Being tested
A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students
Keywords
Exercise, Adherence
Medical subject headings
Motor Activity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College StudentsBehavioural

    Also called Comparing the Physical Activity Guidelines for Americans to The Move Your Way Campaign Methods of Exercise Prescription Among College Students

    A randomized controlled trial comparing the 2018 Physical Activity Guidelines for Americans weekly recommendations of 150-minutes of moderate intensity physical activity plus 2 days of muscle-strengthening physical activity to the Move Your Way Campaign message of increasing any and all physical activity to accumulate more movement throughout the week across all types and intensities.

Study groups in NCT04286919
Study groupRoleWhat they receive
ExRx#1: Physical Activity GuidelinesActive comparatorExRx#1 uses the Frequency, Intensity, Time, and Type or FITT principle of exercise prescription to prescribe the Physical Activity Guidelines for Americans which is a weekly goal of 150-minutes of moderate intensity aerobic physical activity plus 2 days of muscle strengthening physical activity. ExRx#1 communicates the ultimate goal of the physical activity guidelines for Americans using an image adopted from the physical activity guidelines website that depicts the weekly goal. There are 12 weeks of exercise guidelines that will progress participants from being physically inactive to meeting the physical activity guidelines ultimate weekly goal by providing a weekly prescription of Frequency, Intensity, Time, and Type of physical activity that accomplishes meeting the physical activity guidelines weekly goal.
Receives: Behavioral: A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students
ExRx#2: Heat MapExperimentalExRx#2 uses the heat map image published in the 2018 Physical Activity Guidelines Advisory Committee Scientific Report that communicates the dose-response relationship between increased physical activity and improved health to prescribe the message that all physical activity across all Frequencies, Intensities, Time bouts and Types (FITT) counts towards health. ExRx#2 is founded in the Integrated Behavior Change Theory and emphasizes that all physical activity matters regardless of FITT as depicted by the heat map image. There are 12 weeks of exercise guidelines that will progress participants from being physically inactive to meeting the ExRx#2 heat map ultimate weekly goal of moving more throughout the day across all intensities in order to achieve optimal health as represented by the deep green color on the bottom right of the heat map image.
Receives: Behavioral: A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity Volume change from Baseline to 12 weeks

    Actical® (Mini Meter, Respironics Inc.) accelerometers will be given to participants to wear on their hip for 4 consecutive days including 2 weekdays and 2 weekend days as an objective measure of PA volume in MET-hours/day. This data will be collected at baseline before the exercise guidelines start and at week 12 of the exercise guidelines to measure change from baseline to 12 weeks.

    Measured: 12 weeks

Secondary outcomes (1)
  1. Autonomy Score Change from Baseline to 12 weeks

    Motivation for Physical Activity will be assessed by a questionnaire developed using the Self-Determination theory which is found to be valid and reliable in assessing type of motivation for PA in adults. This instrument has 16 items that will allow researchers to determine type of motivation (e.g., intrinsic versus external) and create a relative autonomy index for each subject as a direct result of the scoring of this questionnaire. This score is used to detect level of autonomy in exercise. This measure will be administered at baseline and 12 weeks to measure change from baseline over 12 weeks.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start22 Feb 2019
  3. Primary completion28 May 2020
  4. Study completion28 May 2020

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial with 1 control group and 1 intervention group. The control group is getting the standard of care exercise prescription based on the 2018 physical activity guidelines for Americans and the intervention group is getting a new method of prescribing exercise based on new research informing the 2018 Move Your Way initiative where all physical activity across all types and intensities is advised.
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04286919
Sponsor's protocol ID
H18-266
Acronym
HEAT
Status last verified
Aug 2020
First submitted
20 Feb 2020
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared. All data will be analyzed and presented in aggregate as accepted by the University of Connecticut IRB.

Publications

  • Powell KE, King AC, Buchner DM, Campbell WW, DiPietro L, Erickson KI, Hillman CH, Jakicic JM, Janz KF, Katzmarzyk PT, Kraus WE, Macko RF, Marquez DX, McTiernan A, Pate RR, Pescatello LS, Whitt-Glover MC. The Scientific Foundation for the Physical Activity Guidelines for Americans, 2nd Edition. J Phys Act Health. 2018 Dec 17:1-11. doi: 10.1123/jpah.2018-0618. Online ahead of print.

    PubMed 30558473
  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PubMed 22818936
  • Riebe D, Ehrman J, Liquori G, Magal M. ACSM's Guidelines for Exercise Testing and Prescription tenth edition. 10th ed. Wolters Kluwer: Katie Feltman; 2018.

  • Hagger MS, Chatzisarantis NL. An integrated behavior change model for physical activity. Exerc Sport Sci Rev. 2014 Apr;42(2):62-9. doi: 10.1249/JES.0000000000000008.

    PubMed 24508739
  • Williams SL, French DP. What are the most effective intervention techniques for changing physical activity self-efficacy and physical activity behaviour--and are they the same? Health Educ Res. 2011 Apr;26(2):308-22. doi: 10.1093/her/cyr005. Epub 2011 Feb 14.

    PubMed 21321008
  • Samdal GB, Eide GE, Barth T, Williams G, Meland E. Effective behaviour change techniques for physical activity and healthy eating in overweight and obese adults; systematic review and meta-regression analyses. Int J Behav Nutr Phys Act. 2017 Mar 28;14(1):42. doi: 10.1186/s12966-017-0494-y.

    PubMed 28351367
  • Chatzisarantis NL, Hagger MS, Smith B. Influences of perceived autonomy support on physical activity within the theory of planned behavior. European Journal of Social Psychology 2007;37(5):934-954.

  • Keating XD, Guan J, Pinero JC, Bridges DM. A meta-analysis of college students' physical activity behaviors. J Am Coll Health. 2005 Sep-Oct;54(2):116-25. doi: 10.3200/JACH.54.2.116-126.

    PubMed 16255324
  • Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.

    PubMed 12471307
  • Hill LS, Reid F, Morgan JF, Lacey JH. SCOFF, the development of an eating disorder screening questionnaire. Int J Eat Disord. 2010 May;43(4):344-51. doi: 10.1002/eat.20679.

    PubMed 19343793
  • Simpson K, Parker B, Capizzi J, Thompson P, Clarkson P, Freedson P, Pescatello LS. Validity and reliability question 8 of the Paffenbarger Physical Activity Questionnaire among healthy adults. J Phys Act Health. 2015 Jan;12(1):116-23. doi: 10.1123/jpah.2013-0013. Epub 2014 Apr 11.

    PubMed 24733349
  • Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

    PubMed 23851406
  • Ibrahim JG, Chen M, Lipsitz SR, Herring AH. Missing-data methods for generalized linear models: A comparative review. Journal of the American Statistical Association 2005;100(469):332-346.

  • Rubin DB. Inference and missing data. Biometrika 1976;63(3):581-592.

  • American Society of, Hand Therapists. Clinical assessment recommendations. 1992.

Questions about this trial

What is this clinical trial studying?

A study of Physical Activity and Health Behavior, run by University of Connecticut 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 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity Volume change from Baseline to 12 weeks (time frame: 12 weeks). 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 NCT04286919, which also lists 39 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 7 Aug 2020.

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