Healthy Young AdultsNCT02851017
Exergaming Versus Gym-based Exercise for Postural Control, Flow and Technology Acceptance
A study testing Exercise in people with Healthy Young Adults, run by Northumbria University.
Trial summary
Balance training is an important component of physical fitness, however due to the mundane and often repetitive nature of balance training alone this is often forgotten about and as a result people may be more susceptible to postural control instabilities. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female,
- Aged 18-50 years,
- Physically active (three or more moderate-vigorous physical activity sessions per week), free from injury (no musculoskeletal injuries or neurological conditions)
- Able to take part in four weeks of exercise.
Who cannot join
- Unable to give informed consent and/or to comprehend and write English,
- Current (or history of) any medical condition or injury which would contraindicate participation,
- Allergy to alcohol wipes and/or adhesive tape
- Previous experience of using the XBOX Kinect™.
About this study
Official title: Exergaming (XBOX Kinect™) Versus Traditional Gym-based Exercise for Postural Control, Flow and Technology Acceptance in Healthy Adults: a Randomised Controlled Trial
Balance training is an important component of physical fitness, however due to the mundane and often repetitive nature of balance training alone this is often forgotten about and as a result people may be more susceptible to postural control instabilities. A potential solution to the mundane aspect of balance training is the use of exergaming (interactive exercise and gaming combined) through the use of commercial gaming systems such as the Nintendo Wii, Dance Dance Revolution (DDR) and more recently the XBOX Kinect. The aim of the investigation was to assess the XBOX Kinect versus traditional balance training on postural control, flow and technology acceptance.
Read the detailed description
Exergaming - exercise with the use of an interactive computer-generated environment - is increasingly used in physical rehabilitation. Benefits have been reported in a range of clinical populations (people with neurological problems children with cerebral palsy and learning difficulties, Parkinson' disease, multiple sclerosis and older people. Balance training is an important focus of such rehabilitation. Previous literature regarding the effects of exergaming as a method of balance-training has mainly been conducted using the Nintendo Wii™ and the Wii™ fit where people must stand on a balance board to play the games. Although literature has shown that traditional balance training alone is effective in improving balance in a range of populations, studies comparing exergaming with "traditional" balance exercises (SEBT, trampolines and wobble boards) have shown mixed results from both exergaming and traditional balance training groups improving in postural control outcomes to greater improvement in the exergaming group over traditional balance exercise. A potential reason for the differentiation if results could be due to different movements required in the "traditional" balance exercises rather than there being something inherently different about exercising in a virtual environment. There is also a dearth of randomized controlled trials (RCT) in this area so the evidence base is limited. Furthermore, few have studied the important psychological aspect of exergaming, in particular acceptance and flow experience. The aim of this study was to assess the effects of exergaming using the XBOX Kinect™ system, versus, traditional gym-based exercise, with no virtual stimuli (TGB) on: (1) postural control, (2) technology acceptance (3) flow experience and (4) exercise intensity in young healthy adults. Matching of intensity of exercise, in the two groups, was assessed objectively, by Heart Rate and subjectively by Borg RPE during all exercise sessions. To our knowledge this is the first paper to compare the effects of exergaming against matched traditional exercises where the movement patterns, intensity and physiological demand was matched and assessed across groups.
- Conditions
- Healthy Young Adults
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
This study is designed to examine and comparing there intervention program on postural control, flow and technology acceptance in young healthy adults.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming group (XBOX Kinect | Experimental | Kinect™ exercise group performed sessions on three non-consecutive days per week for 4 weeks (12 sessions in total). Receives: Other: Exercise |
| Traditional gym based exercise group | Experimental | Traditional gym based (TGB) exercise group performed sessions on three non-consecutive days per week for 4 weeks (12 sessions in total). Those in the TGB group performed exercises that were matched for sequence, intensity, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading as required in the Kinect™ group. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Postural sway was measured using a portable Kistler™ force platform (Model 9286AA, W 40 x L 60 x H 3.5cm). Participants were instructed to stand as still as possible with their arms by their side and eyes open, on their dominant leg (preferred kicking) for five periods of 30 seconds. Between trials, participants stepped off the force plate to allow calibration of the equipment which gave a 30 seconds rest.
Measured: Change from baseline (week 1) to post intervention (week 4)
Flow State Scale
The questionnaire consist of a 36-item questionnaire with nine subscales and response options on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Dimensions of flow include challenge-skill balance (CB; skills match the task and will be successful); clear goals (CG; experience of having a pre-set goal which on is aiming to achieve); unambiguous feedback (UF; feedback on performance); concentration of task (CT; focused on task); paradox of control (PC; performs task with ease); action-awareness-merging (AM; automatic response to task); transformation of time (TT; time speeds up or slows down during activity); loss of self-consciousness (LS; immersed in task) and autotelic experience (AE; activity intrinsically rewarding).
Measured: Change from baseline (week 1) to post intervention (week 4)
Unified Theory of Acceptance and Use of Technology (UTAUT)
Technology acceptance was measured using UTAUT which comprised a 7-point Likert scale, with response options on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). The questionnaire has six main domains, performance expectancy (PE; system will help performance), Effort Expectancy (EE; ease of using system), Social Influence (SI; degree in which others believe they should use system), Facilitating Conditions (FC; support in using the system), Self-efficacy (SE; confidence in using the system) and Behavioural Intention (BI; intention to use the system again).
Measured: Change from baseline (week 1) to post intervention (week 4)
Secondary outcomes (2)
Heart Rate
Heart rate (HR) was recorded using a Polar™ Heart Rate Monitor™ (FS2C), recording watch and T31 coded chest strap (Polar Electro, Oy, Finland). Mean HR was collected at the end of every exercise session and calculated as a percentage of predicted HR max (220 - age).
Measured: Change from baseline (week 1) to post intervention (week 4)
BORG subjective exertion scale
For a subjective measure of physiological cost the BORG Rate of Perceived Exertion (RPE) scale was used. Mean RPE data were recorded in each exercise session. RPE was defined as how hard participants felt their body was working in general based on the physical sensations they may experience during the activity, including increases in HR, respiration, breathing rate, sweating, and muscle fatigue.
Measured: Change from baseline (week 1) to post intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Teesside University
- Responsible party
- Sponsor
- Investigators
- Gill Barry, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851017
- Sponsor's protocol ID
- HLS-GB-17-7-16
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Esculier JF, Vaudrin J, Beriault P, Gagnon K, Tremblay LE. Home-based balance training programme using Wii Fit with balance board for Parkinsons's disease: a pilot study. J Rehabil Med. 2012 Feb;44(2):144-50. doi: 10.2340/16501977-0922.
PubMed 22266676dos Santos Mendes FA, Pompeu JE, Modenesi Lobo A, Guedes da Silva K, Oliveira Tde P, Peterson Zomignani A, Pimentel Piemonte ME. Motor learning, retention and transfer after virtual-reality-based training in Parkinson's disease--effect of motor and cognitive demands of games: a longitudinal, controlled clinical study. Physiotherapy. 2012 Sep;98(3):217-23. doi: 10.1016/j.physio.2012.06.001. Epub 2012 Jul 9.
PubMed 22898578Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
PubMed 20508185Bryanton C, Bosse J, Brien M, McLean J, McCormick A, Sveistrup H. Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. Cyberpsychol Behav. 2006 Apr;9(2):123-8. doi: 10.1089/cpb.2006.9.123.
PubMed 16640463Weiss PL, Bialik P, Kizony R. Virtual reality provides leisure time opportunities for young adults with physical and intellectual disabilities. Cyberpsychol Behav. 2003 Jun;6(3):335-42. doi: 10.1089/109493103322011650.
PubMed 12855092Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.
PubMed 22898575Robinson J, Dixon J, Macsween A, van Schaik P, Martin D. The effects of exergaming on balance, gait, technology acceptance and flow experience in people with multiple sclerosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Apr 17;7:8. doi: 10.1186/s13102-015-0001-1. eCollection 2015.
PubMed 25969739Van Schaik P, Blake J, Pernet F, Spears I, Fencott C. Virtual augmented exercise gaming for older adults. Cyberpsychol Behav. 2008 Feb;11(1):103-6. doi: 10.1089/cpb.2007.9925.
PubMed 18275322Venkatesh V, Morris M, Davis G, Davis F. User acceptance of information technology: toward a unified view. Management Information Systems Quarterly. 27:425-78, 2003.
Jackson SA, Marsh H. Development and validation of a scale to measure optimal experience: The Flow State Scale. J Sport and Exercise Psychology. 18:17-35, 1996.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Barry G, van Schaik P, MacSween A, Dixon J, Martin D. Exergaming (XBOX Kinect) versus traditional gym-based exercise for postural control, flow and technology acceptance in healthy adults: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2016 Aug 23;8(1):25. doi: 10.1186/s13102-016-0050-0. eCollection 2016.
PubMed 27555917
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergaming (XBOX Kinect™) Versus Traditional Gym-based Exercise for Postural Control, Flow and Technology Acceptance in Healthy Adults: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02851017
- Acronym / sponsor ID
- HLS-GB-17-7-16
- Conditions
- Healthy Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Teesside University
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Balance training is an important component of physical fitness, however due to the mundane and often repetitive nature of balance training alone this is often forgotten about and as a result people may be more susceptible to postural control instabilities. A potential solution to the mundane aspect of balance training is the use of exergaming (interactive exercise and gaming combined) through the use of commercial gaming systems such as the Nintendo Wii, Dance Dance Revolution (DDR) and more recently the XBOX Kinect. The aim of the investigation was to assess the XBOX Kinect versus traditional balance training on postural control, flow and technology acceptance.
Detailed description
Exergaming - exercise with the use of an interactive computer-generated environment - is increasingly used in physical rehabilitation. Benefits have been reported in a range of clinical populations (people with neurological problems children with cerebral palsy and learning difficulties, Parkinson' disease, multiple sclerosis and older people. Balance training is an important focus of such rehabilitation. Previous literature regarding the effects of exergaming as a method of balance-training has mainly been conducted using the Nintendo Wii™ and the Wii™ fit where people must stand on a balance board to play the games. Although literature has shown that traditional balance training alone is effective in improving balance in a range of populations, studies comparing exergaming with "traditional" balance exercises (SEBT, trampolines and wobble boards) have shown mixed results from both exergaming and traditional balance training groups improving in postural control outcomes to greater improvement in the exergaming group over traditional balance exercise. A potential reason for the differentiation if results could be due to different movements required in the "traditional" balance exercises rather than there being something inherently different about exercising in a virtual environment. There is also a dearth of randomized controlled trials (RCT) in this area so the evidence base is limited. Furthermore, few have studied the important psychological aspect of exergaming, in particular acceptance and flow experience. The aim of this study was to assess the effects of exergaming using the XBOX Kinect™ system, versus, traditional gym-based exercise, with no virtual stimuli (TGB) on: (1) postural control, (2) technology acceptance (3) flow experience and (4) exercise intensity in young healthy adults. Matching of intensity of exercise, in the two groups, was assessed objectively, by Heart Rate and subjectively by Borg RPE during all exercise sessions. To our knowledge this is the first paper to compare the effects of exergaming against matched traditional exercises where the movement patterns, intensity and physiological demand was matched and assessed across groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming group (XBOX Kinect | Experimental | Other: ExerciseKinect™ exercise group performed sessions on three non-consecutive days per week for 4 weeks (12 sessions in total). |
| Traditional gym based exercise group | Experimental | Other: ExerciseTraditional gym based (TGB) exercise group performed sessions on three non-consecutive days per week for 4 weeks (12 sessions in total). Those in the TGB group performed exercises that were matched for sequence, intensity, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading as required in the Kinect™ group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female,
- Aged 18-50 years,
- Physically active (three or more moderate-vigorous physical activity sessions per week), free from injury (no musculoskeletal injuries or neurological conditions)
- Able to take part in four weeks of exercise.
Key exclusion criteria (4 listed)
- Unable to give informed consent and/or to comprehend and write English,
- Current (or history of) any medical condition or injury which would contraindicate participation,
- Allergy to alcohol wipes and/or adhesive tape
- Previous experience of using the XBOX Kinect™.
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 |
|---|---|---|
| ExerciseThis study is designed to examine and comparing there intervention program on postural control, flow and technology acceptance in young healthy adults. | Other | Exergaming group (XBOX Kinect, Traditional gym based exercise group |
Primary outcome
Postural control
Time frame: Change from baseline (week 1) to post intervention (week 4)
Postural sway was measured using a portable Kistler™ force platform (Model 9286AA, W 40 x L 60 x H 3.5cm). Participants were instructed to stand as still as possible with their arms by their side and eyes open, on their dominant leg (preferred kicking) for five periods of 30 seconds. Between trials, participants stepped off the force plate to allow calibration of the equipment which gave a 30 seconds rest.
Flow State Scale
Time frame: Change from baseline (week 1) to post intervention (week 4)
The questionnaire consist of a 36-item questionnaire with nine subscales and response options on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Dimensions of flow include challenge-skill balance (CB; skills match the task and will be successful); clear goals (CG; experience of having a pre-set goal which on is aiming to achieve); unambiguous feedback (UF; feedback on performance); concentration of task (CT; focused on task); paradox of control (PC; performs task with ease); action-awareness-merging (AM; automatic response to task); transformation of time (TT; time speeds up or slows down during activity); loss of self-consciousness (LS; immersed in task) and autotelic experience (AE; activity intrinsically rewarding).
Unified Theory of Acceptance and Use of Technology (UTAUT)
Time frame: Change from baseline (week 1) to post intervention (week 4)
Technology acceptance was measured using UTAUT which comprised a 7-point Likert scale, with response options on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). The questionnaire has six main domains, performance expectancy (PE; system will help performance), Effort Expectancy (EE; ease of using system), Social Influence (SI; degree in which others believe they should use system), Facilitating Conditions (FC; support in using the system), Self-efficacy (SE; confidence in using the system) and Behavioural Intention (BI; intention to use the system again).
2 secondary outcomes
Heart Rate
Time frame: Change from baseline (week 1) to post intervention (week 4)
BORG subjective exertion scale
Time frame: Change from baseline (week 1) to post intervention (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 22266676Esculier JF, Vaudrin J, Beriault P, Gagnon K, Tremblay LE. Home-based balance training programme using Wii Fit with balance board for Parkinsons's disease: a pilot study. J Rehabil Med. 2012 Feb;44(2):144-50. doi: 10.2340/16501977-0922.
- Background: PubMed 22898578dos Santos Mendes FA, Pompeu JE, Modenesi Lobo A, Guedes da Silva K, Oliveira Tde P, Peterson Zomignani A, Pimentel Piemonte ME. Motor learning, retention and transfer after virtual-reality-based training in Parkinson's disease--effect of motor and cognitive demands of games: a longitudinal, controlled clinical study. Physiotherapy. 2012 Sep;98(3):217-23. doi: 10.1016/j.physio.2012.06.001. Epub 2012 Jul 9.
- Background: PubMed 20508185Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
- Background: PubMed 16640463Bryanton C, Bosse J, Brien M, McLean J, McCormick A, Sveistrup H. Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. Cyberpsychol Behav. 2006 Apr;9(2):123-8. doi: 10.1089/cpb.2006.9.123.
- Background: PubMed 12855092Weiss PL, Bialik P, Kizony R. Virtual reality provides leisure time opportunities for young adults with physical and intellectual disabilities. Cyberpsychol Behav. 2003 Jun;6(3):335-42. doi: 10.1089/109493103322011650.
- Background: PubMed 22898575Pompeu JE, Mendes FA, Silva KG, Lobo AM, Oliveira Tde P, Zomignani AP, Piemonte ME. Effect of Nintendo Wii-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial. Physiotherapy. 2012 Sep;98(3):196-204. doi: 10.1016/j.physio.2012.06.004. Epub 2012 Jul 25.
- Background: PubMed 25969739Robinson J, Dixon J, Macsween A, van Schaik P, Martin D. The effects of exergaming on balance, gait, technology acceptance and flow experience in people with multiple sclerosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Apr 17;7:8. doi: 10.1186/s13102-015-0001-1. eCollection 2015.
- Background: PubMed 18275322Van Schaik P, Blake J, Pernet F, Spears I, Fencott C. Virtual augmented exercise gaming for older adults. Cyberpsychol Behav. 2008 Feb;11(1):103-6. doi: 10.1089/cpb.2007.9925.
- BackgroundVenkatesh V, Morris M, Davis G, Davis F. User acceptance of information technology: toward a unified view. Management Information Systems Quarterly. 27:425-78, 2003.
- BackgroundJackson SA, Marsh H. Development and validation of a scale to measure optimal experience: The Flow State Scale. J Sport and Exercise Psychology. 18:17-35, 1996.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Derived from this study: PubMed 27555917Barry G, van Schaik P, MacSween A, Dixon J, Martin D. Exergaming (XBOX Kinect) versus traditional gym-based exercise for postural control, flow and technology acceptance in healthy adults: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2016 Aug 23;8(1):25. doi: 10.1186/s13102-016-0050-0. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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.
Gill Barry, PhD principal investigator
Northumbria University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Young Adults, run by Northumbria University.
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 4 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: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Postural control (time frame: Change from baseline (week 1) to post intervention (week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851017, which also lists 12 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 4 Aug 2016.