Ultrarunners Longitudinal TRAcking Study (ULTRA)
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| ClinicalTrials.gov Identifier: NCT02014038 |
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Recruitment Status :
Enrolling by invitation
First Posted : December 17, 2013
Last Update Posted : December 17, 2013
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| Condition or disease |
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| Arthritis Osteoporosis Injuries |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 2452 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 20 Years |
| Official Title: | Ultrarunners Longitudinal TRAcking Study (ULTRA) |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | December 2012 |
| Estimated Study Completion Date : | December 2031 |
- 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. ]
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014038
| United States, California | |
| Stanford University School of Medicine | |
| Palo Alto, California, United States, 94304 | |
| Principal Investigator: | Eswar Krishnan, MD | Stanford University | |
| Principal Investigator: | Martin Hoffman, MD | University of California, Davis |
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT02014038 History of Changes |
| Other Study ID Numbers: |
21271 |
| First Posted: | December 17, 2013 Key Record Dates |
| Last Update Posted: | December 17, 2013 |
| Last Verified: | December 2013 |
Keywords provided by Stanford University:
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Ultrarunners ultramarathon runners ULTRA Physical activity |
Health Risks sedentary moderately active |
Additional relevant MeSH terms:
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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |