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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention group | Experimental | 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. |
|
| Control group | No Intervention | Participants maintain their original physical activity and lifestyle habits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-intensity combined aerobic and resistance exercise training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm progressive motility | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm concentration | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Puyu Su, Professor | Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34806474 | Background | Hajizadeh Maleki B, Tartibian B, Chehrazi M. Effectiveness of Exercise Training on Male Factor Infertility: A Systematic Review and Network Meta-analysis. Sports Health. 2022 Jul-Aug;14(4):508-517. doi: 10.1177/19417381211055399. Epub 2021 Nov 20. |
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IPD will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.
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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 | 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 | 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 |
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 | 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 |