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CompletedNCT06804291Updated Feb 3, 2025

The Effect of Cycling, Running, and Playing Rugby on Three Biomarkers That May Indicate Brain Injury

An interventional study of Running and Cycling in Healthy Male and Female Subjects, sponsored by Appalachian State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Appalachian State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial was to determine if and how the biomarkers neurofilament light (NfL), brain lipid binding protein (BLBP), and amyloid precursor protein (APP) accumulated over 72 hours in venous blood following running, cycling, or playing rugby as compared to a non-exercising control group. Participants in this study were recreationally active and healthy males and females 18 - 49 years of age. The main questions it aimed to answer was:

Do NfL, BLBP, and APP increase following exercise? Researchers compared the accumulation of NfL, BLBP, and NfL among runners, cyclists, rugby players, controls, and between sexes in each category.

Participants were asked to either run, bike, play a rugby match, or abstain from exercise. In the exercising group, blood was drawn from a vein prior to the activity, immediately after the activity, 30 minutes after the activity, 1 hour after the activity, 24 hours after the activity, 48 hours after the activity, and 72 hours after the activity. In the non-exercising group blood was drawn from a vein one time.

Read the detailed description

Participants were recruited for this study from fall 2021 - spring 2022. Participants recruited to play in a rugby match were current members of the university men's and women's club rugby team. Running participants consisted of members of the university's men's and women's running teams as well as recreational runners. Cycling participants consisted of members of the university's cycling club as well as recreational cyclists. Male rugby athletes played two 40-minute halves while female rugby athletes played two 20-minute halves. These are typical match times for men's and women's rugby. Runners were asked to run 6.44 kilometers at their own pace, and cyclists were asked to cycle 39 kilometers at their own pace. A control group comprised of both sedentary and recreationally active individuals was also recruited and asked to refrain from exercise for 24 hours.

Blood was drawn from an antecubital vein in the exercising groups before and after exercise as well as 30 minutes, 1-, 24-, 48-, and 72-hours after exercise. Only one blood draw was taken in the control group.

The blood biomarkers neurofilament light (NfL), brain lipid binding protein (BLBP), and amyloid precursor protein were then measured in the venous blood and compared within groups, among groups, and between sexes.

02

Conditions studied

  • Healthy Male and Female Subjects

Keywords

  • Brain injury biomarkers
03

In context

Lead sponsor

Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Apparently Healthy
  • Those in the running group must be able to run 6.44 kilometers
  • Those in the cycling group must be able to cycle 39 kilometers
  • Those in the ruby group must be members of the university club rugby team

Exclusion criteria

Exclusion Criteria:

  • Individuals with diabetes
  • Individuals with heart disease
  • Individuals who are pregnant
  • Individuals who get light-headed or dizzy while donating blood
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Running Group

    Participants run 6.44 kilometers. Venous blood is drawn prior to the run, immediately after the run, 30 minutes after the run, and 1-, 24-, 48, and 72-hours after the run.

    Other: Running

  • Active comparator
    Cycling Group

    Participants cycle 39 kilometers. Venous blood is drawn prior to cycling, immediately after cycling, 30 minutes after cycling, and 1-, 24-, 48, and 72-hours after cycling.

    Other: Cycling

  • Active comparator
    Rugby Group

    Participants play one rugby match. Venous blood is drawn prior to the match, immediately after the match, 30 minutes after the match and 1-, 24-, 48, and 72-hours after the match.

    Other: Rugby

  • Placebo comparator
    Control Group

    Participants refrained from exercise for 24 hours followed by one blood draw.

    Other: control group

Interventions

  • OtherRunning

    Participants were expected to run 6.44 kilometers.

    Also known as: Jogging

  • OtherCycling

    Participants were expected to cycle 39 kilometers

    Also known as: Biking

  • OtherRugby

    Participants were expected to play in one rugby match.

  • Othercontrol group

    Participants were asked to refrain from exercise for 24 hours.

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. Blood Biomarkers

    Neurofilament light (NfL) was measured in venous blood samples collected from participants. NfL was measured using enzyme-linked immunosorbent assays (ELISAs) in pg·mL-1.

    Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.

  2. Blood Biomarkers

    Brain lipid binding protein (BLBP) was measured in venous blood samples collected from participants. BLBP was measured using enzyme-linked immunosorbent assays (ELISAs) in ng·mL-1.

    Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.

  3. Blood Biomarkers

    Amyloid precursor protein (APP) was measured in venous blood samples collected from participants. APP was measured using enzyme-linked immunosorbent assays (ELISAs) in ng·mL-1.

    Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.

07

Study locations

1 site
  • Appalachian State University
    Boone, North Carolina 28608, United States
08

References and documents

Individual participant data

Plan to share: No — The data set is small and collected from a specific population. Sharing IPD may indirectly identify some subjects.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2021 to primary completion in Feb 2022, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2025
First posted
Feb 3, 2025
StartActual
Oct 16, 2021
Primary completionActual
Feb 15, 2022
CompletionActual
Feb 15, 2022
Last update
Feb 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06804291
Lead sponsor
Appalachian State University
Responsible party
Matthew Rogatzki (Assistant Professor, Appalachian State University) — Principal investigator
First posted
Feb 3, 2025
Start date
Oct 16, 2021
Primary completion
Feb 15, 2022
Completion
Feb 15, 2022
Last update
Feb 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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