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

The Effect of Different Exercise Modes on Serum Concentrations of NfL, APP, and BLBP: a Nonrandomized Control Trial Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male and Female Subjects
• Intervention / Treatment: Other: Running; Other: Cycling; Other: Rugby; Other: control group

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Boone, North Carolina, United States, 28608
      • Appalachian State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Participants were expected to run 6.44 kilometers.; Other Names: Jogging
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; Participants were expected to cycle 39 kilometers; Other Names: Biking
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; Participants were expected to play in one rugby match.
Placebo Comparator: Control Group; Participants refrained from exercise for 24 hours followed by one blood draw.	Other: control group; Participants were asked to refrain from exercise for 24 hours.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Appalachian State University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Brain injury biomarkers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 21-0286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is small and collected from a specific population. Sharing IPD may indirectly identify some subjects.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No