Athletic PerformanceNCT07675577
Event-Specific Adaptations to CrossFit and Running-Based HIIT in Elite Distance Runners at Moderate Altitude
A study testing Running-Based High-Intensity Interval Training (HIIT) and CrossFit-Based High-Intensity Training (CF) in people with Athletic Performance and Physical Endurance, run by University of Sistan and Baluchestan at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance, Physical Endurance, Altitude Training Adaptation
- What is being tested?
- Running-Based High-Intensity Interval Training (HIIT) and CrossFit-Based High-Intensity Training (CF)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2021to 30 Oct 2021
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Incomplete study application or failure to meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
Iran1 site
Sport Sciences Department, University of Sistan and Baluchestan
Zahedan, Sistan and Baluchestan, 98135-986
About this study
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:
Read more
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
Read the detailed description
Background and Rationale:
Altitude training is widely employed by elite middle- and long-distance runners to stimulate key physiological adaptations, including erythropoietic upregulation, expansion of oxygen transport capacity, mitochondrial biogenesis, and skeletal muscle capillarization. These adaptations are considered central mechanisms through which hypoxic exposure enhances endurance performance. Despite the growing adoption of both running-based high-intensity interval training (HIIT) and multimodal CrossFit (CF) as primary high-intensity training modalities in elite endurance sport, no study has directly compared their respective physiological, neuromuscular, performance, and biomarker effects in runners residing and training at moderate altitude. Moreover, the extent to which event specialization (middle-distance: 800-3,000 m vs. long-distance: ≥5,000 m) moderates modality-specific training adaptations remains unexamined. This study is designed to address these gaps by providing the first direct empirical comparison of these two high-intensity training modalities in elite altitude-resident runners, stratified by competitive event specialization.
Study Design:
This is a six-week stratified quasi-experimental study employing a 2×2 factorial design with pre- and post-intervention assessments, conducted during the general preparatory phase of the competitive season at moderate altitude (approximately 1,400 m above sea level) in Zahedan, Iran. The two independent factors are training modality (HIIT vs. CF) and event specialization (middle-distance vs. long-distance). The study protocol has received ethical approval from the Ethics Committee of the University of Sistan and Baluchestan (Approval No. IR.USB.REC.1400.021) and will be conducted in full accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent will be obtained from all participants prior to any study-related procedures.
Randomization and Allocation Concealment:
Eligible participants will be stratified by primary event specialization and randomly allocated to one of two training modalities using computer-generated variable block randomization with block sizes of four and eight, conducted by an independent investigator using R software (version 4.2.1; R Foundation for Statistical Computing, Vienna, Austria). Allocation concealment will be maintained through the use of sequentially numbered, opaque, sealed envelopes, which will be opened only after the completion of all baseline assessments. Baseline equivalence across groups will be confirmed using propensity score matching prior to the commencement of the intervention.
Training Interventions:
All participants will complete five fully supervised training sessions per week for six weeks, with each session lasting 60-75 minutes. All sessions will be conducted at moderate altitude (approximately 1,400 m) on a standard 400-m synthetic track. Exercise intensity will be continuously monitored throughout all sessions using Polar H10 chest-strap heart rate sensors (Polar Electro Oy, Kempele, Finland), with real-time data transmitted to the coaching staff via the Polar Team application.
Intervention 1 - Running-Based High-Intensity Interval Training (HIIT):
Each HIIT session will consist of 4-6 work 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 will self-select their running pace to maintain heart rate within the prescribed target zone throughout each work bout.
Intervention 2 - Multimodal CrossFit Training (CF):
Each CF session will follow a structured four-part format:
Dynamic warm-up incorporating mobility exercises and movement preparation (10-15 minutes) Strength and skill development targeting foundational lifting patterns and gymnastic movements (15-20 minutes) High-intensity Workout of the Day (WOD) maintained at 85-95% HRmax (10-20 minutes) Cool-down consisting of static stretching and controlled breathing exercises (5-10 minutes) WODs will be selected from the official CrossFit programming archive (2021-2023) and individually scaled by a Level 2 CrossFit-certified coach to ensure appropriate and safe loading for each participant. Loading for barbell movements will be prescribed at 30-85% of each participant's baseline one-repetition maximum (1RM) values. Bodyweight and kettlebell movements will be regulated by repetition targets and ratings of perceived exertion (RPE) of 14-18 on the Borg 6-20 scale. Progressive overload will be systematically applied biweekly through incremental increases of 5-10% in load, repetitions, and movement complexity.
Blinding:
Given the inherently observable nature of the training interventions, participant blinding is not feasible in this study. However, all outcome assessors and data analysts will remain masked to group assignment throughout the study period to ensure objective and unbiased evaluation of all outcome measures.
Dietary and Environmental Controls:
All participants will adhere to a standardized nutritional plan of approximately 2,800 ± 150 kcal·day-¹ with a macronutrient distribution of approximately 55% carbohydrates, 25% protein, and 20% fat, supervised and monitored by a registered sports nutritionist. Dietary intake will be assessed using validated three-day food logs at baseline, week 3, and week 6, and records will be analyzed using Nutritionist Pro software (version 7.0; Axxya Systems LLC, Redmond, WA, USA). The introduction of new nutritional supplements will be prohibited throughout the study period, and dietary compliance will be verified weekly via structured interviews. Caffeine consumption will be withheld for a minimum of 24 hours prior to all testing sessions.
All training and testing sessions will be conducted under standardized and monitored environmental conditions (ambient temperature: 25-30°C; relative humidity: 40-50%; wind speed: <2 m·s-¹), measured using a handheld anemometer (Kestrel 3000; Nielsen-Kellerman Co., Boothwyn, PA, USA) prior to each outdoor session. Sleep duration will be maintained at a minimum of seven hours per night, and subjective recovery status will be monitored daily using a validated five-point Likert scale (1 = very poor; 5 = very good).
Statistical Analysis Plan:
Linear mixed-effects models (LMMs) will serve as the primary analytical framework, implemented using the lme4 package in R (version 4.2.1). Models will incorporate fixed effects for group, time, and group × time interaction, with random intercepts specified for individual participants to account for within-subject correlation. Model selection will be guided by the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC), with emphasis on model parsimony. Residual diagnostics will be performed to validate the assumptions of normality, homoscedasticity, and independence.
Between-group differences in change scores will be further examined using analysis of covariance (ANCOVA), adjusting for age, baseline values, and training history. Effect sizes will be quantified using Cohen's d and interpreted as small (0.2), moderate (0.5), or large (0.8). All observed changes will be evaluated against predefined minimal clinically important difference (MCID) thresholds to facilitate meaningful clinical interpretation. The significance level will be set at α = 0.05 for all statistical comparisons.
Sample size was determined a priori using G*Power (version 3.1; Heinrich-Heine-Universität Düsseldorf, Germany). Calculations indicated that a minimum of nine participants per group would provide greater than 80% statistical power to detect a moderate-to-large effect size in the primary outcome of maximal oxygen uptake (VO₂max; α = 0.05; Cohen's d = 0.6; intraclass correlation coefficient r = 0.70).
- Conditions
- Athletic Performance, Physical Endurance, Altitude Training Adaptation, Aerobic Capacity, Neuromuscular Performance, Exercise-Induced Inflammation
- Being tested
- Running-Based High-Intensity Interval Training (HIIT), CrossFit-Based High-Intensity Training (CF)
- Keywords
- CrossFit, High-Intensity Interval Training, HIIT, Distance Running, Elite Runners, Moderate Altitude, VO₂max, Lactate Threshold, Peak Power Output, Erythropoietin, Hemoglobin, Creatine Kinase, Interleukin-6, TNF-alpha, Middle-Distance Running, Long-Distance Running, Altitude Training, Endurance Performance, Neuromuscular Adaptation, Exercise Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running-Based High-Intensity Interval Training (HIIT)Behavioural
Also called Endurance-HIIT
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.
CrossFit-Based High-Intensity Training (CF)Behavioural
Also called Endurance-CF
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: CrossFit-Based High-Intensity Training (CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate Threshold (LT)
Lactate threshold determined from a graded treadmill test using capillary blood lactate sampling and the modified Dmax method.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after 6 weeks of intervention
Secondary outcomes (7)
Peak Power Output (PPO)
Peak mechanical power output measured during a 30-second Wingate Anaerobic Test on a mechanically braked cycle ergometer.
Measured: Baseline and immediately after 6 weeks of intervention
Deadlift One-Repetition Maximum (1RM)
Maximal strength assessed as the highest successfully completed deadlift load using a standardized progressive loading protocol.
Measured: Baseline and immediately after 6 weeks of intervention
Hemoglobin Concentration
Hemoglobin concentration measured from venous blood samples using an automated hematology analyzer.
Measured: Baseline and immediately after 6 weeks of intervention
Erythropoietin (EPO) Concentration
Circulating erythropoietin measured in venous blood samples using duplicate ELISA analysis.
Measured: Baseline and immediately after 6 weeks of intervention
Creatine Kinase (CK) Activity
Serum creatine kinase activity measured as a biomarker of muscle damage using an enzymatic colorimetric assay.
Measured: Baseline and immediately after 6 weeks of intervention
Interleukin-6 (IL-6) Concentration
Circulating IL-6 measured in venous blood samples using duplicate ELISA analysis.
Measured: Baseline and immediately after 6 weeks of intervention
Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Circulating TNF-α measured in venous blood samples using duplicate ELISA analysis.
Measured: Baseline and immediately after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Sep 2021
- Primary completion15 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies 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
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sistan and Baluchestan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan
- Investigators
- Mohammadreza Rezaeipour, Principal investigator, University of Sistan and Baluchestan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675577
- Sponsor's protocol ID
- IR.USB.REC.1400.021
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event-Specific Adaptations to CrossFit and Running-Based HIIT in Elite Distance Runners at Moderate Altitude
- ClinicalTrials.gov ID
- NCT07675577
- Acronym / sponsor ID
- IR.USB.REC.1400.021
- Conditions
- Athletic Performance, Physical Endurance, Altitude Training Adaptation, Aerobic Capacity, Neuromuscular Performance, Exercise-Induced Inflammation
- Keywords
- CrossFit, High-Intensity Interval Training, HIIT, Distance Running, Elite Runners, Moderate Altitude, VO₂max, Lactate Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sistan and BaluchestanUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 30 Jun 2026 (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 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
Detailed description
Background and Rationale:
Altitude training is widely employed by elite middle- and long-distance runners to stimulate key physiological adaptations, including erythropoietic upregulation, expansion of oxygen transport capacity, mitochondrial biogenesis, and skeletal muscle capillarization. These adaptations are considered central mechanisms through which hypoxic exposure enhances endurance performance. Despite the growing adoption of both running-based high-intensity interval training (HIIT) and multimodal CrossFit (CF) as primary high-intensity training modalities in elite endurance sport, no study has directly compared their respective physiological, neuromuscular, performance, and biomarker effects in runners residing and training at moderate altitude. Moreover, the extent to which event specialization (middle-distance: 800-3,000 m vs. long-distance: ≥5,000 m) moderates modality-specific training adaptations remains unexamined. This study is designed to address these gaps by providing the first direct empirical comparison of these two high-intensity training modalities in elite altitude-resident runners, stratified by competitive event specialization.
Study Design:
This is a six-week stratified quasi-experimental study employing a 2×2 factorial design with pre- and post-intervention assessments, conducted during the general preparatory phase of the competitive season at moderate altitude (approximately 1,400 m above sea level) in Zahedan, Iran. The two independent factors are training modality (HIIT vs. CF) and event specialization (middle-distance vs. long-distance). The study protocol has received ethical approval from the Ethics Committee of the University of Sistan and Baluchestan (Approval No. IR.USB.REC.1400.021) and will be conducted in full accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent will be obtained from all participants prior to any study-related procedures.
Randomization and Allocation Concealment:
Eligible participants will be stratified by primary event specialization and randomly allocated to one of two training modalities using computer-generated variable block randomization with block sizes of four and eight, conducted by an independent investigator using R software (version 4.2.1; R Foundation for Statistical Computing, Vienna, Austria). Allocation concealment will be maintained through the use of sequentially numbered, opaque, sealed envelopes, which will be opened only after the completion of all baseline assessments. Baseline equivalence across groups will be confirmed using propensity score matching prior to the commencement of the intervention.
Training Interventions:
All participants will complete five fully supervised training sessions per week for six weeks, with each session lasting 60-75 minutes. All sessions will be conducted at moderate altitude (approximately 1,400 m) on a standard 400-m synthetic track. Exercise intensity will be continuously monitored throughout all sessions using Polar H10 chest-strap heart rate sensors (Polar Electro Oy, Kempele, Finland), with real-time data transmitted to the coaching staff via the Polar Team application.
Intervention 1 - Running-Based High-Intensity Interval Training (HIIT):
Each HIIT session will consist of 4-6 work 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 will self-select their running pace to maintain heart rate within the prescribed target zone throughout each work bout.
Intervention 2 - Multimodal CrossFit Training (CF):
Each CF session will follow a structured four-part format:
Dynamic warm-up incorporating mobility exercises and movement preparation (10-15 minutes) Strength and skill development targeting foundational lifting patterns and gymnastic movements (15-20 minutes) High-intensity Workout of the Day (WOD) maintained at 85-95% HRmax (10-20 minutes) Cool-down consisting of static stretching and controlled breathing exercises (5-10 minutes) WODs will be selected from the official CrossFit programming archive (2021-2023) and individually scaled by a Level 2 CrossFit-certified coach to ensure appropriate and safe loading for each participant. Loading for barbell movements will be prescribed at 30-85% of each participant's baseline one-repetition maximum (1RM) values. Bodyweight and kettlebell movements will be regulated by repetition targets and ratings of perceived exertion (RPE) of 14-18 on the Borg 6-20 scale. Progressive overload will be systematically applied biweekly through incremental increases of 5-10% in load, repetitions, and movement complexity.
Blinding:
Given the inherently observable nature of the training interventions, participant blinding is not feasible in this study. However, all outcome assessors and data analysts will remain masked to group assignment throughout the study period to ensure objective and unbiased evaluation of all outcome measures.
Dietary and Environmental Controls:
All participants will adhere to a standardized nutritional plan of approximately 2,800 ± 150 kcal·day-¹ with a macronutrient distribution of approximately 55% carbohydrates, 25% protein, and 20% fat, supervised and monitored by a registered sports nutritionist. Dietary intake will be assessed using validated three-day food logs at baseline, week 3, and week 6, and records will be analyzed using Nutritionist Pro software (version 7.0; Axxya Systems LLC, Redmond, WA, USA). The introduction of new nutritional supplements will be prohibited throughout the study period, and dietary compliance will be verified weekly via structured interviews. Caffeine consumption will be withheld for a minimum of 24 hours prior to all testing sessions.
All training and testing sessions will be conducted under standardized and monitored environmental conditions (ambient temperature: 25-30°C; relative humidity: 40-50%; wind speed: <2 m·s-¹), measured using a handheld anemometer (Kestrel 3000; Nielsen-Kellerman Co., Boothwyn, PA, USA) prior to each outdoor session. Sleep duration will be maintained at a minimum of seven hours per night, and subjective recovery status will be monitored daily using a validated five-point Likert scale (1 = very poor; 5 = very good).
Statistical Analysis Plan:
Linear mixed-effects models (LMMs) will serve as the primary analytical framework, implemented using the lme4 package in R (version 4.2.1). Models will incorporate fixed effects for group, time, and group × time interaction, with random intercepts specified for individual participants to account for within-subject correlation. Model selection will be guided by the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC), with emphasis on model parsimony. Residual diagnostics will be performed to validate the assumptions of normality, homoscedasticity, and independence.
Between-group differences in change scores will be further examined using analysis of covariance (ANCOVA), adjusting for age, baseline values, and training history. Effect sizes will be quantified using Cohen's d and interpreted as small (0.2), moderate (0.5), or large (0.8). All observed changes will be evaluated against predefined minimal clinically important difference (MCID) thresholds to facilitate meaningful clinical interpretation. The significance level will be set at α = 0.05 for all statistical comparisons.
Sample size was determined a priori using G*Power (version 3.1; Heinrich-Heine-Universität Düsseldorf, Germany). Calculations indicated that a minimum of nine participants per group would provide greater than 80% statistical power to detect a moderate-to-large effect size in the primary outcome of maximal oxygen uptake (VO₂max; α = 0.05; Cohen's d = 0.6; intraclass correlation coefficient r = 0.70).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Endurance-HIIT | Experimental | Behavioral: Running-Based High-Intensity Interval Training (HIIT)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. |
| Endurance-CF | Experimental | Behavioral: CrossFit-Based High-Intensity Training (CF)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. |
| SemiEnd-HIIT | Experimental | Behavioral: Running-Based High-Intensity Interval Training (HIIT)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. |
| SemiEnd-CF | Experimental | Behavioral: CrossFit-Based High-Intensity Training (CF)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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Running-Based High-Intensity Interval Training (HIIT)Also: Endurance-HIITParticipants 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. | Behavioural | Endurance-HIIT, SemiEnd-HIIT |
| CrossFit-Based High-Intensity Training (CF)Also: Endurance-CFParticipants 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 | Behavioural | Endurance-CF, SemiEnd-CF |
Primary outcome
Lactate Threshold (LT)
Time frame: Baseline and immediately after 6 weeks of intervention
Lactate threshold determined from a graded treadmill test using capillary blood lactate sampling and the modified Dmax method.
Maximal Oxygen Uptake (VO₂max)
Time frame: Baseline and immediately after 6 weeks of intervention
VO₂max assessed by automated breath-by-breath cardiopulmonary exercise testing during an incremental running protocol to volitional exhaustion.
1,500-Meter Time Trial Performance
Time frame: Baseline and immediately after 6 weeks of intervention
Time to complete a 1,500-meter maximal effort run on a standardized 400-meter synthetic track, recorded using an infrared timing system.
5,000-Meter Time Trial Performance
Time frame: Baseline and immediately after 6 weeks of intervention
Time to complete a 5,000-meter maximal effort run on a standardized 400-meter synthetic track, recorded using an infrared timing system.
7 secondary outcomes
Peak Power Output (PPO)
Time frame: Baseline and immediately after 6 weeks of intervention
Deadlift One-Repetition Maximum (1RM)
Time frame: Baseline and immediately after 6 weeks of intervention
Hemoglobin Concentration
Time frame: Baseline and immediately after 6 weeks of intervention
Erythropoietin (EPO) Concentration
Time frame: Baseline and immediately after 6 weeks of intervention
Creatine Kinase (CK) Activity
Time frame: Baseline and immediately after 6 weeks of intervention
Interleukin-6 (IL-6) Concentration
Time frame: Baseline and immediately after 6 weeks of intervention
Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Time frame: Baseline and immediately after 6 weeks of intervention
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared.
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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.
Mohammadreza Rezaeipour principal investigator
University of Sistan and Baluchestan
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-Based High-Intensity Interval Training (HIIT) and CrossFit-Based High-Intensity Training (CF) in people with Athletic Performance and Physical Endurance, run by University of Sistan and Baluchestan at 1 site in Iran.
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 8 inclusion and 6 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 30 Jun 2026. 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 Iran. 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. 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?
Lactate Threshold (LT) (time frame: Baseline and immediately after 6 weeks of intervention). The study lists 4 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 30 Jun 2026.