Healthy Male and Female SubjectsNCT06804291
The Effect of Cycling, Running, and Playing Rugby on Three Biomarkers That May Indicate Brain Injury
A study testing Running, Cycling and Rugby in people with Healthy Male and Female Subjects, run by Appalachian State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- Running, Cycling and Rugby
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with diabetes
- Individuals with heart disease
- Individuals who are pregnant
- Individuals who get light-headed or dizzy while donating blood
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University
Boone, North Carolina, 28608
About this study
Official title: 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.
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.
- Conditions
- Healthy Male and Female Subjects
- Being tested
- Running, Cycling, Rugby, control group
- Keywords
- Brain injury biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RunningOther
Also called Jogging
Participants were expected to run 6.44 kilometers.
CyclingOther
Also called Biking
Participants were expected to cycle 39 kilometers
RugbyOther
Participants were expected to play in one rugby match.
control groupOther
Also called Control
Participants were asked to refrain from exercise for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Rugby |
| Control Group | Placebo comparator | Participants refrained from exercise for 24 hours followed by one blood draw. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start16 Oct 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Rogatzki, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804291
- Sponsor's protocol ID
- 21-0286
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data set is small and collected from a specific population. Sharing IPD may indirectly identify some subjects.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Exercise Modes on Serum Concentrations of NfL, APP, and BLBP: a Nonrandomized Control Trial Exploratory Study
- ClinicalTrials.gov ID
- NCT06804291
- Acronym / sponsor ID
- 21-0286
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Brain injury biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Running Group | Active comparator | Other: RunningParticipants 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. |
| Cycling Group | Active comparator | Other: CyclingParticipants 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. |
| Rugby Group | Active comparator | Other: RugbyParticipants 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. |
| Control Group | Placebo comparator | Other: control groupParticipants refrained from exercise for 24 hours followed by one blood draw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Individuals with diabetes
- Individuals with heart disease
- Individuals who are pregnant
- Individuals who get light-headed or dizzy while donating blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RunningAlso: JoggingParticipants were expected to run 6.44 kilometers. | Other | Running Group |
| CyclingAlso: BikingParticipants were expected to cycle 39 kilometers | Other | Cycling Group |
| RugbyParticipants were expected to play in one rugby match. | Other | Rugby Group |
| control groupAlso: ControlParticipants were asked to refrain from exercise for 24 hours. | Other | Control Group |
Primary outcome
Blood Biomarkers
Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.
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.
Blood Biomarkers
Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.
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.
Blood Biomarkers
Time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No. The data set is small and collected from a specific population. Sharing IPD may indirectly identify some subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running, Cycling and Rugby in people with Healthy Male and Female Subjects, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Biomarkers (time frame: Baseline, 0, 0.5, 1, 24, 48, 72 hours post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.