- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867627
Effect of Combined Aerobic and Resistance Exercise on Semen Quality Among Chinese College Students
Effect of Moderate-intensity Combined Aerobic and Resistance Exercise on Semen Quality in Chinese College Students
The goal of this randomized controlled clinical trial is to investigate the effects of moderate-intensity combined aerobic and resistance exercise on semen quality in Chinese college students. The main question is aim to explore whether moderate-intensity combined aerobic and resistance exercise can improve semen quality.
Participants in the intervention group will receive moderate-intensity combined aerobic and resistance exercise three times a week for a period of 12 weeks (The time range is from March 17, 2025 to June 8, 2025. Excluding weekends, Labor Day, and the traditional Chinese Qingming Festival and the Dragon Boat Festival during that period, a total of 32 training sessions are planned). The control group are requested to maintain their normal daily activities. Both groups receive semen routine and serum sex hormones testing before and after the intervention.
Researchers will compare the change in semen routine parameters from baseline to post-intervention at 12 weeks between the intervention and control groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators will conduct a randomized controlled trial to examine whether moderate-intensity combined aerobic and resistance exercise can improve semen quality. A total of 60 participants will be recruited from one university. Inclusion criteria were college students aged 18 to 24 who signed informed consent form, good health with no eating disorders, mental health disorders, chronic diseases, serious systemic illnesses, genitourinary diseases or infections, and were assessed as having "low" physical activity on the self-reported International Physical Activity Questionnaire (IPAQ) over the past year, with sperm progressive motility of less than 32%, at least two evaluations at three-month intervals. Exclusion criteria include smoking, alcohol dependence, and use of drugs that affect sperm production function such as hormones and antibiotics within the past 3 months, and history of reproductive system surgery (e.g., cryptorchidism, postoperative varicocele). After stratification by BMI, participants were assigned 1:1 to the intervention and control groups.
The intervention group will receive 12 weeks of moderate-intensity combined aerobic and resistance exercise training for 60 minutes three times per week on non-consecutive days (The time range is from March 17, 2025 to June 8, 2025. Excluding weekends, Labor Day, and the traditional Chinese Qingming Festival and the Dragon Boat Festival during that period, a total of 32 training sessions are planned). Aerobic exercise is carried out in the form of running and skipping rope, and resistance exercise involves different muscle groups in the upper and lower limbs of the body. All training sessions will be conducted daily at the same time (17:00-18:00) under the guidance of a professional physical education teacher and two trained postgraduate medical students. Before the official start of the exercise intervention, participants in the intervention group will undergo a pre-intervention adaptive test to determine the maximum heart rate, and the repetitions maximum (RM) for resistance training.
Training sessions begin with a 10-minute warm-up period that includes jogging and dynamic muscle stretching. This is followed by 20 minutes of running/jumping rope on the playground. Each intervention participant will wear a heart rate armband (Polar OH1, Finland) for real-time heart rate detection to maintain achievement of a predetermined target heart rate and training intensity. Target heart rate of moderate-intensity = maximum heart rate x 64%~76%. Then, after 10 minutes of rest adjustment and preparation, a 20-minute resistance training session will be performed, including all major muscle groups. Exercises for upper body muscles such as push-ups, pull-ups, and band curl; Lower body exercises included squats, tuck jump, and burpee; and exercises for core muscle groups such as plank hold, sit-ups, and hip bridge. Resistance training will start at 50% of 1RM and increases intensity by 10% after every three sessions, with two sets of repetitions and 60-90 seconds of rest between sets. By the third week, it will reach 70% of 1RM, and repeat 3 sets at 70% of 1RM starting at week 4. After the end of week 6, re-evaluate the RM every 3 weeks and repeat 3 sets at 70% of the new 1RM (i.e., starting from Week 7 and Week 10), maintaining a 60-90 second rest between each sets. The Borg rating of perceived exercise (RPE) is combined with target heart rate for monitoring exercise intensity during exercise implementation. RPE will be applied at the end of warm-up, aerobic exercise, and resistance exercise to assess the subjective perception of participants during exercise. RPE scores of 12-13 indicate moderate intensity. After resistance training, investigators will perform a 10-minute relaxation session that includes slow walking and static muscle stretching.
The control group did not receive exercise intervention and maintained their original physical activity habits. All participants were required to maintain normal dietary habits during the study period. The primary outcome of this study is to compare the change of sperm progressive motility between intervention and control groups from pre- to post-intervention at 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- College student, 18 to 22 years old.
- Good health with no eating disorders, mental health disorders, chronic diseases (such as diabetes and cardiovascular diseases), serious systemic illnesses, genitourinary diseases or infections.
- Assessed as "low" physical activity trajectory on the self-reported International Physical Activity Questionnaire (IPAQ) over the past year.
- In the past year, sperm progressive motility of less than 32% on at least two evaluations at three-month intervals.
Exclusion Criteria:
- Smoking and alcohol dependence.
- Use of drugs that affect sperm production function, such as hormones and antibiotics, in the past 3 months.
- History of reproductive system surgery (e.g., cryptorchidism, postoperative varicocele).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Participants maintain their original physical activity and lifestyle habits.
|
|
|
Experimental: Exercise intervention group
Participants will receive 12 weeks of moderate-intensity combined aerobic and resistance exercise training for 60 minutes three times per week on non-consecutive days (A total of 32 training sessions, excluding weekends, Labor Day, and the traditional Chinese Qingming Festival and the Dragon Boat Festival during that period).
Aerobic exercises take the form of running and jumping rope.
Resistance exercises involve different muscle groups in the upper and lower body.
|
Training sessions begin with a 10-minute warm-up period that includes jogging and dynamic muscle stretching.
This is followed by 20 minutes of running/jumping rope on the playground.
Each intervention participant will wear a heart rate armband (Polar OH1, Finland) for real-time heart rate detection to maintain achievement of a predetermined target heart rate and training intensity.
Then, after 10 minutes of rest adjustment and preparation, a 20-minute resistance training session will be performed, including all major muscle groups.
Resistance training will start at 50% of 1RM and increases intensity by 10% after every three sessions, with two sets of repetitions and 60-90 seconds of rest between sets.
By the third week, it will reach 70% of 1RM, and repeat 3 sets at 70% of 1RM starting at week 4.
After the end of week 6, re-evaluate the RM every 3 weeks and repeat 3 sets at 70% of the new 1RM (i.e., starting from Week 7 and Week 10), maintaining a 60-90 second rest between each sets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sperm progressive motility
Time Frame: Baseline and 12 weeks
|
Sperm progressive motility and sperm concentration are two major parameters for evaluating semen quality and infertility in males.
In the previous one-year prospective intensive follow-up study, basically no sperm concentration among college students was below the WHO standard.
In addition, sperm progressive motility is more stable and less susceptible to time and seasonal influences than other semen parameters.
Therefore, investigators chose sperm progressive motility as the primary outcome.
The computer-assisted sperm analysis (CASA) technology is applied to measure sperm progressive motility.
According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm progressive motility is ≥ 32%.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sperm concentration
Time Frame: Baseline and 12 weeks
|
Measurement of sperm concentration using CASA.
According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm concentration is ≥ 15 million/ml.
|
Baseline and 12 weeks
|
|
Sperm total motility
Time Frame: Baseline and 12 weeks
|
Measurement of sperm total motility using CASA.
According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm total motility is ≥ 40%.
|
Baseline and 12 weeks
|
|
Semen volume
Time Frame: Baseline and 12 weeks
|
Measure semen volume using the weighing method recommended by the WHO laboratory manual for human semen analysis and processing (5th edition).
The semen cup containing the semen specimen was weighed on an electronic balance and the result was subtracted from the previously determined dead weight of the cup to obtain the semen weight.
The semen density was standardized to 1 g/ml and the semen volume was obtained by dividing the semen weight by the semen density.
According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm volume is ≥ 1.5 ml.
|
Baseline and 12 weeks
|
|
Sperm count
Time Frame: Baseline and 12 weeks
|
The total sperm count is obtained by multiplying the semen volume and the sperm concentration that have been obtained.
According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm count is ≥ 39 million.
|
Baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Testosterone
Time Frame: Baseline and 12 weeks
|
Serum levels of testosterone is measured using the fully automated chemiluminescent immunoassay analyzer (Siemens, USA).
The testosterone serum level in adult males is approximately 9.01-45.75
nmol/L.
|
Baseline and 12 weeks
|
|
Follicle stimulating hormone
Time Frame: Baseline and 12 weeks
|
Serum levels of follicle stimulating hormone is measured using the fully automated chemiluminescent immunoassay analyzer (Siemens, USA).
The level of follicle stimulating hormone in adult males is approximately 4-8 IU/L.
|
Baseline and 12 weeks
|
|
Luteinizing hormone
Time Frame: Baseline and 12 weeks
|
Serum levels of luteinizing hormone is measured using the fully automated chemiluminescent immunoassay analyzer (Siemens, USA).
The level of luteinizing hormone in adult males is approximately 5-10 IU/L.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Puyu Su, Professor, Anhui Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 82240107
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
product manufactured in and exported from the U.S.
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.
Clinical Trials on Semen Quality
-
Institut Universitari DexeusUniversitat Politècnica de Catalunya; Dexeus Clinic WomanCompleted
-
Horsens HospitalVidens- og Forskningscenter for Alternativ BehandlingCompleted
-
Hamad Medical CorporationFairhaven HealthUnknownInfertility, Male | Antioxidants | Semen QualityQatar
-
Aalborg UniversityAalborg University HospitalCompleted
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
ReproNovo ApsRecruitingSemen QualityUnited States
-
Copenhagen University Hospital at HerlevRigshospitalet, DenmarkTerminatedInfertility | Varicocele | Semen QualityDenmark
-
CONRADJohns Hopkins University; Eastern Virginia Medical SchoolCompleted
-
ART Fertility Clinics LLCRecruitingICSI | PGT-A | Semen AnalysisUnited Arab Emirates
-
VIVUS LLCCompletedAvanfil ADME | Semen Exposure | Sperm FunctionUnited States
Clinical Trials on Moderate-intensity combined aerobic and resistance exercise training
-
Riphah International UniversityRecruitingPsychological Well-BeingPakistan
-
Mayo ClinicCompleted
-
University of South CarolinaCompletedObstructive Sleep ApneaUnited States
-
General Hospital Murska SobotaUniversity of Primorska; University of LjubljanaUnknownCoronary Artery Disease | Heart Failure With Reduced Ejection FractionSlovenia
-
Riphah International UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
Riphah International UniversityCompletedPolycystic Ovary SyndromePakistan
-
Federal University of UberlandiaTerminatedHypertension | MenopauseBrazil
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedDiabetes Mellitus, Type 2Pakistan