- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07738640
Effects of Two Endurance Training Programs on 5-km Running Performance in Recreational Runners
Effects of Lactate Threshold Training and Pyramidal-to-Polarized Endurance Training on 5-km Running Performance, Physiological Capacity, and Post-exercise Neural Responses in Recreational Runners: A Randomized Controlled Trial
This study will examine the effects of two 8-week endurance training programs on 5-km running performance in recreational runners. Participants will be randomly assigned to a lactate threshold training group, a pyramidal-to-polarized endurance training group, or a control group that maintains usual physical activity without receiving the study training program.
Before and after the intervention, participants will complete assessments of 5-km running performance, aerobic fitness, lactate threshold, running economy, blood lactate responses, and brain activity recorded before and after maximal exercise. The study will compare changes among the three groups and examine whether physiological and post-exercise neural responses are associated with improvements in running performance.
The main purpose is to determine whether the two training programs produce different improvements in 5-km running performance and to better understand the physiological and neural adaptations associated with endurance training in recreational runners.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shuqi Jia
- Phone Number: +8613327732991
- Email: jsq2221111006@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women aged [18-30] years.
- Recreational runners with regular running or endurance-training experience for at least [6 months].
- Currently completing running training at least [2-3 times per week].
- Able to complete a continuous 5-km run.
- Willing and able to complete the 8-week training intervention and all study assessments.
- Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Current cardiovascular, respiratory, metabolic, neurological, or other medical conditions that may contraindicate maximal exercise or endurance training.
- Current musculoskeletal injury or pain that limits running or participation in maximal exercise testing.
- History of loss of consciousness, epilepsy, severe head injury, or other neurological conditions that may affect electroencephalographic recordings.
- Use of medications or substances known to substantially affect cardiovascular, metabolic, or central nervous system responses to exercise.
- Participation in another structured exercise intervention or clinical study during the study period.
- Inability or unwillingness to comply with the assigned training program, testing procedures, or study requirements.
- Any other condition judged by the investigators to make participation unsafe or to substantially affect the validity of the study outcomes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lactate Threshold Training Group
Participants assigned to this group will complete an 8-week endurance training program primarily prescribed around their individually determined lactate threshold intensity.
Training intensity will be individualized using baseline physiological testing and adjusted according to the study protocol.
Participants will complete the prescribed training sessions throughout the intervention period and will undergo the same pre- and post-intervention assessments as the other study groups.
|
Participants will complete an 8-week individualized endurance training program prescribed primarily around the lactate threshold.
Training intensity will be determined from baseline physiological testing.
The program will specify the frequency, duration, and intensity of each training session and will be adjusted according to the study protocol.
|
|
Experimental: Pyramidal-to-Polarized Endurance Training Group
Participants assigned to this group will complete an 8-week periodized endurance training program in which the training-intensity distribution progresses from a pyramidal pattern during the initial phase to a polarized pattern during the later phase.
Exercise intensity will be individualized using baseline physiological testing and adjusted according to the study protocol.
Participants will undergo the same pre- and post-intervention assessments as the other study groups.
|
Participants will complete an 8-week individualized endurance training program in which the training-intensity distribution progresses from a pyramidal pattern during the initial phase to a polarized pattern during the later phase.
Training intensity will be prescribed using individually determined physiological thresholds obtained from baseline testing.
The program will include low-, moderate-, and high-intensity running sessions, with the relative distribution of training time across intensity zones adjusted according to the planned periodization.
Training frequency, session duration, and intensity will be standardized according to the study protocol and monitored throughout the intervention.
|
|
No Intervention: Usual Activity Control Group
Participants assigned to this group will continue their usual physical activity and running habits during the 8-week study period and will not receive either of the structured training programs administered by the research team.
Participants will be asked not to begin any new structured endurance training program during the intervention period and will undergo the same pre- and post-intervention assessments as the training groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 5-km Running Performance
Time Frame: Baseline and immediately after the 8-week intervention
|
5-km running performance will be assessed using a maximal-effort self-paced 5-km run conducted on a standard 400-m outdoor athletics track.
Completion time will be recorded in seconds.
The primary outcome will be the change in 5-km completion time from baseline to the end of the 8-week intervention.
A lower completion time indicates better running performance.
|
Baseline and immediately after the 8-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Maximal Oxygen Uptake
Time Frame: Baseline and immediately after the 8-week intervention
|
Maximal oxygen uptake will be assessed during a graded cardiopulmonary exercise test performed to volitional exhaustion.
Oxygen uptake will be measured breath-by-breath and expressed relative to body mass in milliliters per kilogram per minute.
The outcome will be the change in maximal oxygen uptake from baseline to the end of the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
|
Change in Lactate Threshold
Time Frame: Baseline and immediately after the 8-week intervention
|
Lactate threshold will be determined during an incremental running test using blood lactate measurements and the prespecified threshold-identification method described in the study protocol.
The outcome will be the change in running speed or physiological intensity corresponding to the lactate threshold from baseline to the end of the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
|
Change in Running Economy
Time Frame: Baseline and immediately after the 8-week intervention
|
Running economy will be assessed during steady-state submaximal treadmill running at a standardized speed.
Oxygen uptake will be measured during the steady-state period and expressed relative to body mass.
The outcome will be the change in oxygen cost of running from baseline to the end of the 8-week intervention.
A lower oxygen cost at the same running speed indicates better running economy.
|
Baseline and immediately after the 8-week intervention
|
|
Change in Post-exercise Blood Lactate Concentration
Time Frame: Baseline and immediately after the 8-week intervention, with measurements before exercise and at 5 and 20 minutes after exercise
|
Capillary blood lactate concentration will be measured at prespecified time points before and after maximal exercise.
The outcome will include changes in post-exercise blood lactate concentration and lactate recovery from baseline to the end of the 8-week intervention.
Blood lactate concentration will be expressed in millimoles per liter.
|
Baseline and immediately after the 8-week intervention, with measurements before exercise and at 5 and 20 minutes after exercise
|
|
Change in Post-exercise Electroencephalographic Activity
Time Frame: Baseline and immediately after the 8-week intervention, with electroencephalographic recordings before exercise and at 5 and 20 minutes after exercise
|
Resting electroencephalographic activity will be recorded before maximal exercise and during recovery after exercise.
Prespecified electroencephalographic outcomes will include relative spectral power in selected frequency bands and cortical regions.
The outcome will be the change in post-exercise electroencephalographic responses from baseline to the end of the 8-week intervention.
|
Baseline and immediately after the 8-week intervention, with electroencephalographic recordings before exercise and at 5 and 20 minutes after exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Event-Related Potential Responses During Cognitive Tasks
Time Frame: Baseline and immediately after the 8-week intervention, with recordings before exercise and at 5 and 20 minutes after maximal exercise
|
Event-related potentials will be recorded during prespecified cognitive tasks before and after the 8-week intervention.
Prespecified outcomes will include the amplitude and latency of selected ERP components, including N2 and P3 components, at predefined scalp regions and task conditions.
The outcome will be the change in ERP amplitude and latency from baseline to the end of the intervention, as well as changes in the acute ERP response from before to after maximal exercise.
|
Baseline and immediately after the 8-week intervention, with recordings before exercise and at 5 and 20 minutes after maximal exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SUS-5KM-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.