NCT07675577

Brief Summary

The goal of this clinical trial is to compare the effects of two high-intensity training programs on physical performance and physiological adaptations in elite male middle- and long-distance runners aged 25 to 35 years who live and train at moderate altitude (approximately 1,400 meters above sea level). The main questions it aims to answer are: Does running-based high-intensity interval training improve aerobic fitness and race performance in elite distance runners? Does CrossFit training improve muscle strength, power, and physiological markers in elite distance runners? Researchers will compare running-based high-intensity interval training (HIIT) with CrossFit training to determine how each program affects aerobic capacity, strength, running performance, and selected blood markers. Participants will: Be randomly assigned to either a running-based HIIT program or a CrossFit training program Train five days per week for six weeks under supervision Complete exercise testing before and after the training period, including treadmill fitness testing and timed running trials Provide blood samples before and after the intervention to measure selected physiological markers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 22, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

CrossFitHigh-Intensity Interval TrainingHIITDistance RunningElite RunnersModerate AltitudeVO₂maxLactate ThresholdPeak Power OutputErythropoietinHemoglobinCreatine KinaseInterleukin-6TNF-alphaMiddle-Distance RunningLong-Distance RunningAltitude TrainingEndurance PerformanceNeuromuscular AdaptationExercise Physiology

Outcome Measures

Primary Outcomes (4)

  • Lactate Threshold (LT)

    Lactate threshold determined from a graded treadmill test using capillary blood lactate sampling and the modified Dmax method.

    Baseline and immediately after 6 weeks of intervention

  • Maximal Oxygen Uptake (VO₂max)

    VO₂max assessed by automated breath-by-breath cardiopulmonary exercise testing during an incremental running protocol to volitional exhaustion.

    Baseline and immediately after 6 weeks of intervention

  • 1,500-Meter Time Trial Performance

    Time to complete a 1,500-meter maximal effort run on a standardized 400-meter synthetic track, recorded using an infrared timing system.

    Baseline and immediately after 6 weeks of intervention

  • 5,000-Meter Time Trial Performance

    Time to complete a 5,000-meter maximal effort run on a standardized 400-meter synthetic track, recorded using an infrared timing system.

    Baseline and immediately after 6 weeks of intervention

Secondary Outcomes (7)

  • Peak Power Output (PPO)

    Baseline and immediately after 6 weeks of intervention

  • Deadlift One-Repetition Maximum (1RM)

    Baseline and immediately after 6 weeks of intervention

  • Hemoglobin Concentration

    Baseline and immediately after 6 weeks of intervention

  • Erythropoietin (EPO) Concentration

    Baseline and immediately after 6 weeks of intervention

  • Creatine Kinase (CK) Activity

    Baseline and immediately after 6 weeks of intervention

  • +2 more secondary outcomes

Other Outcomes (1)

  • Back Squat One-Repetition Maximum (1RM)

    Baseline and immediately after 6 weeks of intervention

Study Arms (4)

Endurance-HIIT

EXPERIMENTAL

Elite male runners specializing in long-distance events (≥5,000 m) who performed running-based high-intensity interval training (HIIT) five days per week for six weeks at moderate altitude (approximately 1,400 m). Each session consisted of 4-6 intervals of 2-4 minutes at 90-95% HRmax, interspersed with 2-3 minutes of active recovery at approximately 50% HRmax.

Behavioral: Running-Based High-Intensity Interval Training (HIIT)

Endurance-CF

EXPERIMENTAL

Elite male runners specializing in long-distance events (≥5,000 m) who performed multimodal CrossFit-based high-intensity training five days per week for six weeks at moderate altitude (approximately 1,400 m). Each session included a dynamic warm-up, strength and skill work, a high-intensity Workout of the Day (WOD) at 85-95% HRmax, and a cool-down period.

Behavioral: CrossFit-Based High-Intensity Training (CF)

SemiEnd-HIIT

EXPERIMENTAL

Elite male runners specializing in middle-distance events (800-3,000 m) who performed running-based high-intensity interval training (HIIT) five days per week for six weeks at moderate altitude (approximately 1,400 m). Each session consisted of 4-6 intervals of 2-4 minutes at 90-95% HRmax, interspersed with 2-3 minutes of active recovery at approximately 50% HRmax.

Behavioral: Running-Based High-Intensity Interval Training (HIIT)

SemiEnd-CF

EXPERIMENTAL

Elite male runners specializing in middle-distance events (800-3,000 m) who performed multimodal CrossFit-based high-intensity training five days per week for six weeks at moderate altitude (approximately 1,400 m). Each session included a dynamic warm-up, strength and skill work, a high-intensity Workout of the Day (WOD) at 85-95% HRmax, and a cool-down period.

Behavioral: CrossFit-Based High-Intensity Training (CF)

Interventions

Participants performed five supervised HIIT sessions per week for six weeks at moderate altitude (approximately 1,400 m) in Zahedan, Iran. Each session lasted 60-75 minutes and was conducted on a standard 400-m synthetic track. Sessions consisted of 4-6 intervals of 2-4 minutes duration performed at 90-95% of maximum heart rate (HRmax), interspersed with 2-3 minutes of active recovery at approximately 50% HRmax. Participants self-selected their interval pace to maintain heart rate within the prescribed target zone throughout each work bout. Exercise intensity was continuously monitored using Polar H10 chest-strap heart rate sensors. Progressive overload was applied throughout the intervention period.

Also known as: Endurance-HIIT
Endurance-HIITSemiEnd-HIIT

Participants performed five supervised CrossFit sessions per week for six weeks at moderate altitude (approximately 1,400 m) in Zahedan, Iran. Each session lasted 60-75 minutes and followed a structured four-part format: (i) Dynamic warm-up incorporating mobility exercises and movement preparation (10-15 minutes); (ii) Strength and skill work targeting foundational lifting patterns and gymnastic movements (15-20 minutes); (iii) High-intensity Workout of the Day (WOD) at 85-95% HRmax (10-20 minutes); (iv) Cool-down consisting of static stretching and controlled breathing exercises (5-10 minutes). WODs were selected from the official CrossFit programming archive (2021-2023) and individually scaled by a Level 2 CrossFit-certified coach. Loading for barbell movements was prescribed at 30-85% of baseline 1RM values. Bodyweight and kettlebell movements were regulated by repetition targets and RPE scores of 14-18 on the Borg 6-20 scale. Progressive overload was applied biweekly through increa

Also known as: Endurance-CF
Endurance-CFSemiEnd-CF

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nationally ranked elite male middle- or long-distance runner
  • Ranked within the national top 10 in their respective primary competitive event
  • Aged between 25 and 35 years
  • Minimum of six months of structured high-intensity training prior to enrollment, defined as more than five supervised sessions per week
  • Living and training year-round at moderate altitude (approximately 1,400 m) in Zahedan, Iran
  • Competing in one of the following event categories: middle-distance (800-3,000 m) or long-distance (≥5,000 m)
  • Willing and able to provide written informed consent prior to participation
  • Able to commit to five supervised training sessions per week for the full six-week intervention period

You may not qualify if:

  • Musculoskeletal injury within the three months preceding enrollment
  • Current or recent use of performance-enhancing substances
  • Use of new nutritional supplements during the study period
  • Any medical condition or physical limitation that could interfere with safe participation in high-intensity exercise training
  • Inability to complete the required number of training sessions due to scheduling conflicts or other commitments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Sciences Department, University of Sistan and Baluchestan

Zahedan, Sistan and Baluchestan, 98135-986, Iran

Location

Study Officials

  • Mohammadreza Rezaeipour

    University of Sistan and Baluchestan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Although participants could not be blinded to their assigned training modality due to the inherently observable nature of the interventions, all data analysts and outcome assessors were masked to group assignment throughout the study to ensure objective evaluation of all physiological, performance, and biochemical outcomes.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: A 2×2 factorial design was used to evaluate the independent and combined effects of training modality (running-based HIIT vs. CrossFit) and event specialization (middle-distance: 800-3,000 m vs. long-distance: ≥5,000 m) on physiological, neuromuscular, performance, and biomarker outcomes in elite male runners training at moderate altitude (approximately 1,400 m) over six weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor at the Sport Sciences Department

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 30, 2026

Study Start

September 1, 2021

Primary Completion

October 15, 2021

Study Completion

October 30, 2021

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared.

Time Frame
Data will become available immediately following publication and will be accessible for a period of five years.
Access Criteria
Data will be shared with researchers who provide a statistically sound proposal and sign a data access agreement. Requests should be directed to the corresponding author at rezaeipour@ped.usb.ac.ir.

Locations