Hip FractureNCT02635308
Enhancing Rehabilitation After Hip Fracture
A study testing Unilaterally Biased Resistance Training / "MOVE" in people with Hip Fracture, run by University of Utah.
Trial summary
This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Unilaterally Biased Resistance Training / "MOVE"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Aug 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 50 yrs
- Ability to sign informed consent
- Mental Status MoCA score greater than 22
- Independent community ambulatory prior to hip fracture
- Ability to ambulate greater than 50 feet with or without assistive device
Who cannot join
- Previous hip fracture
- Bilateral hip fracture
- Pathological fracture
- Expected life Expectancy less than one year
- Permanently institutionalized
- Fracture result of multi-trauma
Show all 15Show fewer
- Cardiac abnormalities
- Neuromuscular impairments
- Unstable medical conditions
- Elevated systolic greater than 150 or diastolic blood pressure greater than 100
- Implanted electronic devices
- History of stroke with motor disability
- Alcohol or drug abuse
- Respiratory disease
- Conditions deemed exclusionary by PI or physician
About this study
Official title: Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture
This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Additionally, physical performance during a sit-to-stand task, muscle function (strength/power), physical function measures, muscle composition, and muscle quality (force/unit area), are assessed before and after targeted high-intensity resistance training.
Read the detailed description
Hip fracture is a major public health concern in the United States. Fall-related injuries constitute the leading cause of deaths and disabilities among persons over age 65 years. Hip fracture is consistently identified as one of the most frequent, costly, and devastating non-lethal injuries from a fall. Rehabilitation after hip fracture remains largely unchanged over the last 30 years despite evidence that high-intensity rehabilitation can benefit physical function after hip fracture beyond the recovery typical with "usual care".
Asymmetries demonstrated in physical performance of various tasks, such as gait, balance, and a sit-to-stand transfer, and impaired surgical limb muscle function are evident for years after hip fracture, and may contribute to the high rate of falls and declining function typically encountered by older adults recovering from hip fracture. Implementing a high-intensity rehabilitation approach targeting asymmetries after hip fracture is likely to yield improved symmetry in both physical function and muscle function. This study will recruit older adults who have recently incurred a hip fracture and completed "usual care" physical therapy to determine whether a high-intensity rehabilitation strategy targeting asymmetries in movement strategies and muscle function of the surgical limb can be successfully implemented in this challenging population. In particular, recruitment, adherence to rehab protocol parameters, and retention will be addressed among those who initiate high-resistance training at approximately 8-12wk after hip fracture incidence.
In addition, the investigators will explore the potential of targeted unilaterally-biased resistance training to improve surgical limb function and performance after hip fracture. Specifically, physical performance, muscle function, and muscle quality/composition are recorded and compared pre-/post-training to determine whether improvements occur in conjunction with high-intensity rehabilitation training. Additionally, the investigators will measure improvements in muscle composition that occur as a result of this high-intensity resistance training.
- Conditions
- Hip Fracture
- Being tested
- Unilaterally Biased Resistance Training / "MOVE"
- Keywords
- hip fracture, physical function, muscle function, symmetry
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilaterally Biased Resistance Training / "MOVE"Behavioural
Also called High-Intensity Task Oriented Strength Training / "HI-TOSS"
High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE" Receives: Behavioral: Unilaterally Biased Resistance Training / "MOVE" |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.
Measured: 12 week
muscle power
Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.
Measured: 12 week
Secondary outcomes (11)
sit-to-stand task performance
biomechanics (vGRF) measured during sit-to-stand task performance
Measured: 12 week
usual gait speed
Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.
Measured: 12 week
muscle mass
MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.
Measured: 12 week
Modified Physical Performance Test
The modified physical performance test (mPPT) is a standardized nine-item test designed to assess multiple dimensions of physical function was used to assess overall physical function. Scores are reported on a scale from 0-36.
Measured: 12 week
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14-item objective scale that provides a reliable and valid measure of static balance, with scores less than 45 indicating significant fall risk among older adults. Scores range from 0-56.
Measured: 12 week
Timed up and Go Test
The Timed up and go test is recorded as the time in seconds to stand, walk 3 meters, turn around and return to a chair. The average time of three trials is reported.
Measured: 12 week
Stair Climb Test
The time taken to ascend 10 stairs is reported.
Measured: 12 week
Stair Descent Test
The time taken to descend 10 stairs is reported.
Measured: 12 week
Lower Extremity Measure
The Lower Extremity Measure (LEM) is a 29-item self-report questionnaire that is reliable, valid, and responsive to improvement, with scores of 75 indicating moderate frailty, and scores above 85 indicating normal mobility and physical function after hip fracture. Scores range from 0-100.
Measured: 12 week
Activities Specific Balance Scale
Activities-Specific Balance Confidence (ABC) scale is a 16-item, validated, reliable, self-report scale used to determine balance confidence. Scores range from 0-100.
Measured: 12 week
Six minute walk test
The distance in meters (m) walked in six minutes is recorded.
Measured: 12 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Principal investigator, Robin Marcus, University of Utah
- Investigators
- Robin L Marcus, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635308
- Sponsor's protocol ID
- 00062639
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kneiss JA, Houck JR, Bukata SV, Puzas JE. Influence of upper extremity assistance on lower extremity force application symmetry in individuals post-hip fracture during the sit-to-stand task. J Orthop Sports Phys Ther. 2012 May;42(5):474-81. doi: 10.2519/jospt.2012.3562. Epub 2012 Apr 30.
PubMed 22565360Kneiss JA, Hilton TN, Tome J, Houck JR. Weight-bearing asymmetry in individuals post-hip fracture during the sit to stand task. Clin Biomech (Bristol). 2015 Jan;30(1):14-21. doi: 10.1016/j.clinbiomech.2014.11.012. Epub 2014 Nov 29.
PubMed 25497603Edgren J, Rantanen T, Heinonen A, Portegijs E, Alen M, Kiviranta I, Kallinen M, Sipila S. Effects of progressive resistance training on physical disability among older community-dwelling people with history of hip fracture. Aging Clin Exp Res. 2012 Apr;24(2):171-5. doi: 10.1007/BF03325162.
PubMed 22842835Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipila S. Effects of resistance training on lower-extremity impairments in older people with hip fracture. Arch Phys Med Rehabil. 2008 Sep;89(9):1667-74. doi: 10.1016/j.apmr.2008.01.026.
PubMed 18760151Portegijs E, Sipila S, Rantanen T, Lamb SE. Leg extension power deficit and mobility limitation in women recovering from hip fracture. Am J Phys Med Rehabil. 2008 May;87(5):363-70. doi: 10.1097/PHM.0b013e318164a9e2.
PubMed 18303470Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipila S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9.
PubMed 22884315Host HH, Sinacore DR, Bohnert KL, Steger-May K, Brown M, Binder EF. Training-induced strength and functional adaptations after hip fracture. Phys Ther. 2007 Mar;87(3):292-303. doi: 10.2522/ptj.20050396. Epub 2007 Feb 6.
PubMed 17284548Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. doi: 10.1001/jama.292.7.837.
PubMed 15315998Houck J, Kneiss J, Bukata SV, Puzas JE. Analysis of vertical ground reaction force variables during a Sit to Stand task in participants recovering from a hip fracture. Clin Biomech (Bristol). 2011 Jun;26(5):470-6. doi: 10.1016/j.clinbiomech.2010.12.004. Epub 2010 Dec 31.
PubMed 21196069Miller RR, Eastlack M, Hicks GE, Alley DE, Shardell MD, Orwig DL, Goodpaster BH, Chomentowski PJ, Hawkes WG, Hochberg MC, Ferrucci L, Magaziner J. Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies. J Gerontol A Biol Sci Med Sci. 2015 Jun;70(6):753-6. doi: 10.1093/gerona/glr188.
PubMed 25958401D'Adamo CR, Hawkes WG, Miller RR, Jones M, Hochberg M, Yu-Yahiro J, Hebel JR, Magaziner J. Short-term changes in body composition after surgical repair of hip fracture. Age Ageing. 2014 Mar;43(2):275-80. doi: 10.1093/ageing/aft198. Epub 2013 Dec 25.
PubMed 24370941Penrod JD, Boockvar KS, Litke A, Magaziner J, Hannan EL, Halm EA, Silberzweig SB, Sean Morrison R, Orosz GM, Koval KJ, Siu AL. Physical therapy and mobility 2 and 6 months after hip fracture. J Am Geriatr Soc. 2004 Jul;52(7):1114-20. doi: 10.1111/j.1532-5415.2004.52309.x.
PubMed 15209649Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
PubMed 10995047Visser M, Harris TB, Fox KM, Hawkes W, Hebel JR, Yahiro JY, Michael R, Zimmerman SI, Magaziner J. Change in muscle mass and muscle strength after a hip fracture: relationship to mobility recovery. J Gerontol A Biol Sci Med Sci. 2000 Aug;55(8):M434-40. doi: 10.1093/gerona/55.8.m434.
PubMed 10952365Fox KM, Magaziner J, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R. Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000;11(1):31-5. doi: 10.1007/s001980050003.
PubMed 10663356
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture
- ClinicalTrials.gov ID
- NCT02635308
- Acronym / sponsor ID
- 00062639
- Conditions
- Hip Fracture
- Keywords
- hip fracture, physical function, muscle function, symmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Dec 2015 (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.
This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Additionally, physical performance during a sit-to-stand task, muscle function (strength/power), physical function measures, muscle composition, and muscle quality (force/unit area), are assessed before and after targeted high-intensity resistance training.
Detailed description
Hip fracture is a major public health concern in the United States. Fall-related injuries constitute the leading cause of deaths and disabilities among persons over age 65 years. Hip fracture is consistently identified as one of the most frequent, costly, and devastating non-lethal injuries from a fall. Rehabilitation after hip fracture remains largely unchanged over the last 30 years despite evidence that high-intensity rehabilitation can benefit physical function after hip fracture beyond the recovery typical with "usual care".
Asymmetries demonstrated in physical performance of various tasks, such as gait, balance, and a sit-to-stand transfer, and impaired surgical limb muscle function are evident for years after hip fracture, and may contribute to the high rate of falls and declining function typically encountered by older adults recovering from hip fracture. Implementing a high-intensity rehabilitation approach targeting asymmetries after hip fracture is likely to yield improved symmetry in both physical function and muscle function. This study will recruit older adults who have recently incurred a hip fracture and completed "usual care" physical therapy to determine whether a high-intensity rehabilitation strategy targeting asymmetries in movement strategies and muscle function of the surgical limb can be successfully implemented in this challenging population. In particular, recruitment, adherence to rehab protocol parameters, and retention will be addressed among those who initiate high-resistance training at approximately 8-12wk after hip fracture incidence.
In addition, the investigators will explore the potential of targeted unilaterally-biased resistance training to improve surgical limb function and performance after hip fracture. Specifically, physical performance, muscle function, and muscle quality/composition are recorded and compared pre-/post-training to determine whether improvements occur in conjunction with high-intensity rehabilitation training. Additionally, the investigators will measure improvements in muscle composition that occur as a result of this high-intensity resistance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Unilaterally Biased Resistance Training / "MOVE"High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE" |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 50 yrs
- Ability to sign informed consent
- Mental Status MoCA score greater than 22
- Independent community ambulatory prior to hip fracture
- Ability to ambulate greater than 50 feet with or without assistive device
Key exclusion criteria (15 listed)
- Previous hip fracture
- Bilateral hip fracture
- Pathological fracture
- Expected life Expectancy less than one year
- Permanently institutionalized
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 |
|---|---|---|
| Unilaterally Biased Resistance Training / "MOVE"Also: High-Intensity Task Oriented Strength Training / "HI-TOSS"High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks | Behavioural | Experimental |
Primary outcome
muscle strength
Time frame: 12 week
Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.
muscle power
Time frame: 12 week
Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.
11 secondary outcomes
sit-to-stand task performance
Time frame: 12 week
usual gait speed
Time frame: 12 week
muscle mass
Time frame: 12 week
Modified Physical Performance Test
Time frame: 12 week
Berg Balance Scale
Time frame: 12 week
Timed up and Go Test
Time frame: 12 week
Stair Climb Test
Time frame: 12 week
Stair Descent Test
Time frame: 12 week
Lower Extremity Measure
Time frame: 12 week
Activities Specific Balance Scale
Time frame: 12 week
Six minute walk test
Time frame: 12 week.
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 18 Dec 2015.
- Background: PubMed 22565360Kneiss JA, Houck JR, Bukata SV, Puzas JE. Influence of upper extremity assistance on lower extremity force application symmetry in individuals post-hip fracture during the sit-to-stand task. J Orthop Sports Phys Ther. 2012 May;42(5):474-81. doi: 10.2519/jospt.2012.3562. Epub 2012 Apr 30.
- Background: PubMed 25497603Kneiss JA, Hilton TN, Tome J, Houck JR. Weight-bearing asymmetry in individuals post-hip fracture during the sit to stand task. Clin Biomech (Bristol). 2015 Jan;30(1):14-21. doi: 10.1016/j.clinbiomech.2014.11.012. Epub 2014 Nov 29.
- Background: PubMed 22842835Edgren J, Rantanen T, Heinonen A, Portegijs E, Alen M, Kiviranta I, Kallinen M, Sipila S. Effects of progressive resistance training on physical disability among older community-dwelling people with history of hip fracture. Aging Clin Exp Res. 2012 Apr;24(2):171-5. doi: 10.1007/BF03325162.
- Background: PubMed 18760151Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipila S. Effects of resistance training on lower-extremity impairments in older people with hip fracture. Arch Phys Med Rehabil. 2008 Sep;89(9):1667-74. doi: 10.1016/j.apmr.2008.01.026.
- Background: PubMed 18303470Portegijs E, Sipila S, Rantanen T, Lamb SE. Leg extension power deficit and mobility limitation in women recovering from hip fracture. Am J Phys Med Rehabil. 2008 May;87(5):363-70. doi: 10.1097/PHM.0b013e318164a9e2.
- Background: PubMed 22884315Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipila S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9.
- Background: PubMed 17284548Host HH, Sinacore DR, Bohnert KL, Steger-May K, Brown M, Binder EF. Training-induced strength and functional adaptations after hip fracture. Phys Ther. 2007 Mar;87(3):292-303. doi: 10.2522/ptj.20050396. Epub 2007 Feb 6.
- Background: PubMed 15315998Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. doi: 10.1001/jama.292.7.837.
- Background: PubMed 21196069Houck J, Kneiss J, Bukata SV, Puzas JE. Analysis of vertical ground reaction force variables during a Sit to Stand task in participants recovering from a hip fracture. Clin Biomech (Bristol). 2011 Jun;26(5):470-6. doi: 10.1016/j.clinbiomech.2010.12.004. Epub 2010 Dec 31.
- Background: PubMed 25958401Miller RR, Eastlack M, Hicks GE, Alley DE, Shardell MD, Orwig DL, Goodpaster BH, Chomentowski PJ, Hawkes WG, Hochberg MC, Ferrucci L, Magaziner J. Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies. J Gerontol A Biol Sci Med Sci. 2015 Jun;70(6):753-6. doi: 10.1093/gerona/glr188.
- Background: PubMed 24370941D'Adamo CR, Hawkes WG, Miller RR, Jones M, Hochberg M, Yu-Yahiro J, Hebel JR, Magaziner J. Short-term changes in body composition after surgical repair of hip fracture. Age Ageing. 2014 Mar;43(2):275-80. doi: 10.1093/ageing/aft198. Epub 2013 Dec 25.
- Background: PubMed 15209649Penrod JD, Boockvar KS, Litke A, Magaziner J, Hannan EL, Halm EA, Silberzweig SB, Sean Morrison R, Orosz GM, Koval KJ, Siu AL. Physical therapy and mobility 2 and 6 months after hip fracture. J Am Geriatr Soc. 2004 Jul;52(7):1114-20. doi: 10.1111/j.1532-5415.2004.52309.x.
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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.
Robin L Marcus, PhD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Unilaterally Biased Resistance Training / "MOVE" in people with Hip Fracture, run by University of Utah.
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 15 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 18 Dec 2015. 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?
muscle strength (time frame: 12 week). 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?
On the ClinicalTrials.gov record for NCT02635308, which also lists 15 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 18 Dec 2015.