NCT06804291

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 25, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

Brain injury biomarkers

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

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

Study Arms (4)

Running Group

ACTIVE COMPARATOR

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

Cycling Group

ACTIVE COMPARATOR

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

Rugby Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Other: control group

Interventions

RunningOTHER

Participants were expected to run 6.44 kilometers.

Also known as: Jogging
Running Group
CyclingOTHER

Participants were expected to cycle 39 kilometers

Also known as: Biking
Cycling Group
RugbyOTHER

Participants were expected to play in one rugby match.

Rugby Group

Participants were asked to refrain from exercise for 24 hours.

Also known as: Control
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608, United States

Location

MeSH Terms

Interventions

RunningJoggingalbumin Rugby ParkControl Groups

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2025

First Posted

February 3, 2025

Study Start

October 16, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The data set is small and collected from a specific population. Sharing IPD may indirectly identify some subjects.

Locations