ArthritisNCT02014038
Ultrarunners Longitudinal TRAcking Study (ULTRA)
An observational study of Arthritis and Osteoporosis, run by Stanford University at 1 site in United States.
Trial summary
Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Osteoporosis, Injuries
- How many people
- 2,452 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2016
- How long will I take part?
- 20 Years
- Phase
- Observational
- 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
Study population: Adult healthy volunteers who have completed at least one ULTRA marathon (50K distance or greater) prior to enrollment in the study.
Inclusion Criteria:Healthy adults, able to provide consent, able to do survey online, must have completed one ULTRA marathon prior to participating in this study.
Exclusion Criteria:Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.
Read the detailed description
The intent of this research is to longitudinally study the health of individuals who have run at least one ultramarathon (50K distance or greater) prior to enrollment.Longitudinal data will be collected through periodic (every 1-2 years) survey completion by enrolled subjects over the course of up to 20 years. All surveys will be collected through a secure web-based system used by Stanford University Qualtrics). Minor formatting adjustments will be required when placing into the on-line questionnaire format.
We anticipate that the follow-up surveys will be adjusted prior to use, so they will be submitted to the Institutional Review board as addendum or in continuing review. As indicated elsewhere, subjects will be recruited through an email exchange (referred to as the "Ultralist"), various ultramarathon-related web sites and blogs, and ultramarathon-related magazines. Initial recruitment will continue for up to 12 months or until we have reached our desired sample size. Recruitment material (attached) will include a link to the initial survey. For follow-up surveys, subjects will initially be sent an email (using the address they have provided with the initial survey) that contains a link to the survey and request that they complete the survey. Attempt to contact non-responders will be, in this order, through a second email, phone call, letter to their home, email to identified surrogate, phone call to identified surrogate, and letter to identified surrogate. Publicly available death records will be examined for cases where follow-up cannot be achieved.
- Conditions
- Arthritis, Osteoporosis, Injuries
- Keywords
- Ultrarunners, ultramarathon runners, ULTRA, Physical activity, Health Risks, sedentary, moderately active
- Medical subject headings
- Arthritis, Osteoporosis, Wounds and Injuries, Motor Activity, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare baseline demographic and health (number of lost work days, frequency of various medical conditions, change in BMI with aging) characteristics of ultramarathon runners with published data for less active populations.
- Compare baseline demographic (education level, marital status, amount of TV watching) and health (number of lost work days, frequency of various medical conditions, change in BMI with aging) characteristics of ultramarathon runners with published data for less active populations.
- Compare characteristics of those developing various medical conditions over the course of the longitudinal study with those not developing those conditions.
- Compare the longitudinal risk of developing various medical conditions between ultramarathon runners and those with sedentary or moderately active lifestyles. Knowledge gained from this work will help define if there is an upper limit in activity level for which health benefits are achieved.
Measured: Initailly at 12 months from start of enrollment and every one to two years over the next 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,452 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Lorinda S Chung, Stanford University
- Investigators
- Eswar Krishnan, MD, Principal investigator, Stanford UniversityMartin Hoffman, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014038
- Sponsor's protocol ID
- 21271
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2013
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrarunners Longitudinal TRAcking Study (ULTRA)
- ClinicalTrials.gov ID
- NCT02014038
- Acronym / sponsor ID
- 21271
- Conditions
- Arthritis, Osteoporosis, Injuries
- Keywords
- Ultrarunners, ultramarathon runners, ULTRA, Physical activity, Health Risks, sedentary, moderately active
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,452 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Dec 2013 (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.
Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.
Detailed description
The intent of this research is to longitudinally study the health of individuals who have run at least one ultramarathon (50K distance or greater) prior to enrollment.Longitudinal data will be collected through periodic (every 1-2 years) survey completion by enrolled subjects over the course of up to 20 years. All surveys will be collected through a secure web-based system used by Stanford University Qualtrics). Minor formatting adjustments will be required when placing into the on-line questionnaire format.
We anticipate that the follow-up surveys will be adjusted prior to use, so they will be submitted to the Institutional Review board as addendum or in continuing review. As indicated elsewhere, subjects will be recruited through an email exchange (referred to as the "Ultralist"), various ultramarathon-related web sites and blogs, and ultramarathon-related magazines. Initial recruitment will continue for up to 12 months or until we have reached our desired sample size. Recruitment material (attached) will include a link to the initial survey. For follow-up surveys, subjects will initially be sent an email (using the address they have provided with the initial survey) that contains a link to the survey and request that they complete the survey. Attempt to contact non-responders will be, in this order, through a second email, phone call, letter to their home, email to identified surrogate, phone call to identified surrogate, and letter to identified surrogate. Publicly available death records will be examined for cases where follow-up cannot be achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult healthy volunteers who have completed at least one ULTRA marathon (50K distance or greater) prior to enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare baseline demographic and health (number of lost work days, frequency of various medical conditions, change in BMI with aging) characteristics of ultramarathon runners with published data for less active populations.
Time frame: Initailly at 12 months from start of enrollment and every one to two years over the next 20 years.
1. Compare baseline demographic (education level, marital status, amount of TV watching) and health (number of lost work days, frequency of various medical conditions, change in BMI with aging) characteristics of ultramarathon runners with published data for less active populations. 2. Compare characteristics of those developing various medical conditions over the course of the longitudinal study with those not developing those conditions. 3. Compare the longitudinal risk of developing various medical conditions between ultramarathon runners and those with sedentary or moderately active lifestyles. Knowledge gained from this work will help define if there is an upper limit in activity level for which health benefits are achieved.
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 13 Apr 2023.
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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.
Eswar Krishnan, MD principal investigator
Stanford University
Martin Hoffman, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Osteoporosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Apr 2023. 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?
Compare baseline demographic and health (number of lost work days, frequency of various medical conditions, change in BMI with aging) characteristics of ultramarathon runners with published data for less active populations. (time frame: Initailly at 12 months from start of enrollment and every one to two years over the next 20 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.