AgingEIAMDNCT01787292
Effects of Exercise Intervention on Aging-related Motor Decline
A study testing Stretching Exercise Intervention, Aerobic Exercise Intervention and Self Monitoring in people with Aging and Exercise, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Stretching Exercise Intervention, Aerobic Exercise Intervention and Self Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2013to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living persons between 60 and 85 years of age
Who cannot join
- unmanaged diabetes
- participants completing vigorous exercise per week
- participants whose profession requires vigorous physical labor
- contraindication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
About this study
Official title: Effects of Exercise Intervention on Aging-related Motor Decline (AGING)
The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.
Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.
Read the detailed description
The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.
In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.
Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.
The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.
- Being tested
- Stretching Exercise Intervention, Aerobic Exercise Intervention, Self Monitoring
- Keywords
- Exercise, Magnetic Resonance Imaging, Transcranial Magnetic Stimulation, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching Exercise InterventionBehavioural
- Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
Aerobic Exercise InterventionBehavioural
Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Self MonitoringBehavioural
6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)
| Study group | Role | What they receive |
|---|---|---|
| Stretching Exercise Intervention | Experimental | A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. Receives: Behavioral: Stretching Exercise Intervention |
| Aerobic Exercise Intervention | Experimental | B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. Receives: Behavioral: Aerobic Exercise Intervention |
| Self Monitoring Intervention | Experimental | C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer. Receives: Behavioral: Self Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate Cardiovascular Efficiency After Aerobic Exercise
Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.
Measured: Baseline, 12 weeks, 24 weeks
Estimate of Cardiovascular Efficiency After Balance Training
Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.
Measured: Baseline, 12 weeks, 24 weeks
Silent Period Duration After Exercise Cycling Program
Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds
Measured: Baseline, 12 weeks, 24 weeks
Silent Period Duration for Balance Group
Ipsilateral silent period duration as assessed by TMS
Measured: Baseline, 12 weeks, 24 weeks
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise
Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.
Measured: Baseline to 24 Weeks with cross-over
fMRI Interhemispheric Inhibition Improvement After Balance Training
Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.
Measured: Baseline, 12 weeks, 24 weeks
Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention
Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).
Measured: 24 and 48 weeks
Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention
VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.
Measured: 24 and 48 weeks
Comparison of Silent Period Duration After Aerobic Exercise
Comparison of silent period duration at 24 weeks compared to baseline
Measured: Baseline, 12 weeks, 24 weeks
Comparison of Silent Period Duration After Balance Exercise
Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.
Measured: 24 and 48 weeks
Secondary outcomes (3)
Target Heart Rate Zone for Balance First Participants
Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve.
Measured: 24 and 48 weeks
Target Heart Rate Zone After Aerobic Exercise First
Targeted Heart Rate Zone among participants compared among short term exercise groups
Measured: 24 and 48 weeks
Heart Rate Workload After Home Based Intervention
Measured heart rate after home based intervention
Technical implementation at the facility level prevented acquisition of these metrics until late in the project.
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study start14 Jan 2013
- Primary completion7 Jul 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Keith M. McGregor, PhD MS BA, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787292
- Sponsor's protocol ID
- E0956-W
- Other IDs
- 2012-060697
- Acronym
- EIAMD
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2013
- Last updated
- 20 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGregor KM, Crosson B, Mammino K, Omar J, Garcia PS, Nocera JR. Influences of 12-Week Physical Activity Interventions on TMS Measures of Cortical Network Inhibition and Upper Extremity Motor Performance in Older Adults-A Feasibility Study. Front Aging Neurosci. 2018 Jan 4;9:422. doi: 10.3389/fnagi.2017.00422. eCollection 2017.
PubMed 29354049Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.
PubMed 28367334McGregor KM, Crosson B, Krishnamurthy LC, Krishnamurthy V, Hortman K, Gopinath K, Mammino KM, Omar J, Nocera JR. Effects of a 12-Week Aerobic Spin Intervention on Resting State Networks in Previously Sedentary Older Adults. Front Psychol. 2018 Nov 27;9:2376. doi: 10.3389/fpsyg.2018.02376. eCollection 2018.
PubMed 30542314
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intervention on Aging-related Motor Decline (AGING)
- ClinicalTrials.gov ID
- NCT01787292
- Acronym / sponsor ID
- EIAMD / E0956-W
- Keywords
- Exercise, Magnetic Resonance Imaging, Transcranial Magnetic Stimulation, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Posted 20 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.
Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.
Detailed description
The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.
In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.
Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.
The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer
| Arm | Type | Receives |
|---|---|---|
| Stretching Exercise Intervention | Experimental | Behavioral: Stretching Exercise InterventionA. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. |
| Aerobic Exercise Intervention | Experimental | Behavioral: Aerobic Exercise InterventionB. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. |
| Self Monitoring Intervention | Experimental | Behavioral: Self MonitoringC. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living persons between 60 and 85 years of age
Key exclusion criteria (4 listed)
- unmanaged diabetes
- participants completing vigorous exercise per week
- participants whose profession requires vigorous physical labor
- contraindication to magnetic resonance imaging
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 |
|---|---|---|
| Stretching Exercise InterventionA. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. | Behavioural | Stretching Exercise Intervention |
| Aerobic Exercise InterventionSupervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum. | Behavioural | Aerobic Exercise Intervention |
| Self Monitoring6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling) | Behavioural | Self Monitoring Intervention |
Primary outcome
Estimate Cardiovascular Efficiency After Aerobic Exercise
Time frame: Baseline, 12 weeks, 24 weeks
Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.
Estimate of Cardiovascular Efficiency After Balance Training
Time frame: Baseline, 12 weeks, 24 weeks
Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.
Silent Period Duration After Exercise Cycling Program
Time frame: Baseline, 12 weeks, 24 weeks
Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds
Silent Period Duration for Balance Group
Time frame: Baseline, 12 weeks, 24 weeks
Ipsilateral silent period duration as assessed by TMS
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise
Time frame: Baseline to 24 Weeks with cross-over
Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.
fMRI Interhemispheric Inhibition Improvement After Balance Training
Time frame: Baseline, 12 weeks, 24 weeks
Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.
Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention
Time frame: 24 and 48 weeks
Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).
Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention
Time frame: 24 and 48 weeks
VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.
Comparison of Silent Period Duration After Aerobic Exercise
Time frame: Baseline, 12 weeks, 24 weeks
Comparison of silent period duration at 24 weeks compared to baseline
Comparison of Silent Period Duration After Balance Exercise
Time frame: 24 and 48 weeks
Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.
3 secondary outcomes
Target Heart Rate Zone for Balance First Participants
Time frame: 24 and 48 weeks
Target Heart Rate Zone After Aerobic Exercise First
Time frame: 24 and 48 weeks
Heart Rate Workload After Home Based Intervention
Time frame: 24 and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29354049McGregor KM, Crosson B, Mammino K, Omar J, Garcia PS, Nocera JR. Influences of 12-Week Physical Activity Interventions on TMS Measures of Cortical Network Inhibition and Upper Extremity Motor Performance in Older Adults-A Feasibility Study. Front Aging Neurosci. 2018 Jan 4;9:422. doi: 10.3389/fnagi.2017.00422. eCollection 2017.
- Results publication: PubMed 28367334Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.
- Results publication: PubMed 30542314McGregor KM, Crosson B, Krishnamurthy LC, Krishnamurthy V, Hortman K, Gopinath K, Mammino KM, Omar J, Nocera JR. Effects of a 12-Week Aerobic Spin Intervention on Resting State Networks in Previously Sedentary Older Adults. Front Psychol. 2018 Nov 27;9:2376. doi: 10.3389/fpsyg.2018.02376. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Keith M. McGregor, PhD MS BA principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching Exercise Intervention, Aerobic Exercise Intervention and Self Monitoring in people with Aging and Exercise, run by VA Office of Research and Development 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 1 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 20 Feb 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?
Yes. Results are posted in the registry (first posted 20 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimate Cardiovascular Efficiency After Aerobic Exercise (time frame: Baseline, 12 weeks, 24 weeks). 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?
On the ClinicalTrials.gov record for NCT01787292, which also lists 3 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 20 Feb 2020.