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OpenTrials
Completed

NCT Number: NCT02014038

Ultrarunners Longitudinal TRAcking Study (ULTRA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of California, Davis

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Dec 17, 2013
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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