Healthy AdultNCT07427979
Sex Differences in Exercise-Induced Hypoalgesia
A study testing Aerobic exercise using cycle ergometer in people with Healthy Adult, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
Exercise-induced hypoalgesia (EIH) refers to the reduction in pain sensitivity following acute exercise. Although aerobic exercise has been shown to induce hypoalgesia in healthy individuals, it remains unclear whether the magnitude of this response differs between men and women. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Aerobic exercise using cycle ergometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults
- Age between 18 and 65 years
- Able to perform moderate-to-vigorous aerobic exercise
- Able to understand study procedures
- Cleared for exercise participation using the Physical Activity Readiness Questionnaire (PAR-Q).
Who cannot join
- Cardiovascular, respiratory, neurological, or metabolic diseases contraindicating exercise
- Current musculoskeletal pain or injury
- Analgesic medication use within 24 hours prior to testing
- Vigorous exercise within 24 hours prior to testing
- Any contraindication to aerobic exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Centro Superior de Estudios Universitarios La Salle
Madrid, Madrid, 28023
Álvaro Reina Varona, MSc., (+34) 91 740 19 80 ext. 506, alvaro.reina@lasallecampus.es
About this study
Official title: Sex Differences in Exercise-Induced Hypoalgesia Following Aerobic Exercise Using a Lower-Limb Cycle Ergometer: A Quasi-Experimental Study
Exercise-induced hypoalgesia (EIH) refers to the reduction in pain sensitivity following acute exercise. Although aerobic exercise has been shown to induce hypoalgesia in healthy individuals, it remains unclear whether the magnitude of this response differs between men and women.
This quasi-experimental study aims to evaluate sex differences in pressure pain thresholds following a standardized aerobic exercise protocol using a lower-limb cycle ergometer. Pressure pain thresholds will be assessed before exercise, immediately after exercise, and 30 minutes after exercise in healthy adults aged 18 to 65 years.
The findings of this study may contribute to improving individualized exercise prescription strategies based on sex differences in pain modulation.
Read the detailed description
Exercise-induced hypoalgesia (EIH) is characterized by a transient reduction in pain sensitivity following acute physical exercise, measurable through pressure pain thresholds (PPTs). Aerobic exercise has been consistently shown to increase PPTs in healthy individuals through activation of endogenous pain inhibitory mechanisms, including opioid and non-opioid pathways.
However, the influence of biological sex on EIH remains unclear, and understanding potential differences between men and women could have important implications for exercise prescription in clinical and healthy populations.
This quasi-experimental study will include healthy male and female participants aged 18-65 years. Participants will undergo a single session of aerobic exercise on a lower-limb cycle ergometer at 70% heart rate reserve for 30 minutes.
Pressure pain thresholds will be assessed using a validated digital pressure algometer at:
- Quadriceps muscle (local site)
- Lateral epicondyle region (remote site)
Measurements will be performed at three time points:
- Pre-exercise
- Immediately post-exercise
- 30 minutes post-exercise
The primary analysis will compare changes in pressure pain thresholds between men and women using ANCOVA models adjusting for baseline values.
- Conditions
- Healthy Adult
- Being tested
- Aerobic exercise using cycle ergometer
- Keywords
- Exercise-Induced Hypoalgesia, Sex differences, Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise using cycle ergometerBehavioural
Participants will perform a 30-minute aerobic exercise protocol using a lower-limb cycle ergometer at 70% heart rate reserve. The protocol includes:
- 5-minute warm-up
- 20-minute exercise at target intensity
- 5-minute cool-down Heart rate will be monitored continuously using a validated heart rate monitor.
| Study group | Role | What they receive |
|---|---|---|
| Male participants | Experimental | Participants will perform a 30-minute aerobic exercise protocol on a lower-limb cycle ergometer at 70% heart rate reserve, including warm-up and cool-down periods. Receives: Behavioral: Aerobic exercise using cycle ergometer |
| Female participants | Experimental | Aerobic exercise using lower-limb cycle ergometer. Participants will perform the same aerobic exercise protocol. Receives: Behavioral: Aerobic exercise using cycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold at Quadriceps
Pressure pain threshold measured using a digital pressure algometer at the quadriceps muscle.
Measured: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise
Secondary outcomes (1)
Pressure Pain Threshold at Lateral Epicondyle
Pressure pain threshold measured at a remote anatomical site using pressure algometry.
Measured: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Álvaro Reina Varona, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427979
- Sponsor's protocol ID
- CSEULS-PI-002/2026
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data regarding the principal and secondary outcomes: Pressure Pain Thresholds for the quadriceps and epicondyle sites.
Publications
Awali, A., Nevsimal, R., O'Melia, S., Alsouhibani, A., & Bement, M. Hoeger. (2019). (305) The Contribution of Experimental Pain to the Sex Differences in Exercise-Induced Hypoalgesia. The Journal of Pain, 20(4, Supplement), S50. https://doi.org/10.1016/j.jpain.2019.01.462 Belavy, Daniel L., Oosterwijck, Jessica Van, Clarkson, Matthew, Dhondt, Evy, Mundell, Niamh L., Miller, Clint T., & Owen, Patrick J. (2021). Pain sensitivity is reduced by exercise training: Evidence from a systematic review and meta-analysis. Neuroscience & Biobehavioral Reviews, 120, 100-108. https://doi.org/10.1016/J.NEUBIOREV.2020.11.012 Cano-Climent, Antoni, Oliver-Roig, Antonio, Cabrero-García, Julio, Vries, Jolanda de, & Richart-Martínez, Miguel. (2017). The Spanish version of the Fatigue Assessment Scale: Reliability and validity assessment in postpartum women. PeerJ, 5(9). https://doi.org/10.7717/PEERJ.3832 Castañeda, Francisco Javier Rubio, Aznar, Concepción Tomás, & Baquero, Carmen Muro. (2017). Validity, Reliability and Associated Factors of the International Physical Activity Questionnaire Adapted to Elderly (IPAQ-E). Revista Espanola de Salud Publica, 91. Chesterton, Linda S., Sim, Julius, Wright, Christine C., & Foster, Nadine E. (2007). Interrater Reliability of Algometry in Measuring Pressure Pain Thresholds in Healthy Humans, Using Multiple Raters. The Clinical Journal of Pain, 23(9), 760-766. https://doi.org/10.1097/AJP.0b013e318154b6ae Day, M. L., McGuigan, M. R., Brice, G., & Foster, C. (2004). Monitoring exercise intensity during resistance training using the session RPE scale. Journal of Strength and Conditioning Research, 18(2), 353-358. https://doi.org/10.1519/R-13113.1 Faul, Franz, Erdfelder, Edgar, Lang, Albert-Georg, & Buchner, Axel. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. https://doi.org/10.3758/BF03193146 Kinser, Ann M., Sands, William A., & Stone, M
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Exercise-Induced Hypoalgesia Following Aerobic Exercise Using a Lower-Limb Cycle Ergometer: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07427979
- Acronym / sponsor ID
- CSEULS-PI-002/2026
- Conditions
- Healthy Adult
- Keywords
- Exercise-Induced Hypoalgesia, Sex differences, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 23 Feb 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.
Exercise-induced hypoalgesia (EIH) refers to the reduction in pain sensitivity following acute exercise. Although aerobic exercise has been shown to induce hypoalgesia in healthy individuals, it remains unclear whether the magnitude of this response differs between men and women.
This quasi-experimental study aims to evaluate sex differences in pressure pain thresholds following a standardized aerobic exercise protocol using a lower-limb cycle ergometer. Pressure pain thresholds will be assessed before exercise, immediately after exercise, and 30 minutes after exercise in healthy adults aged 18 to 65 years.
The findings of this study may contribute to improving individualized exercise prescription strategies based on sex differences in pain modulation.
Detailed description
Exercise-induced hypoalgesia (EIH) is characterized by a transient reduction in pain sensitivity following acute physical exercise, measurable through pressure pain thresholds (PPTs). Aerobic exercise has been consistently shown to increase PPTs in healthy individuals through activation of endogenous pain inhibitory mechanisms, including opioid and non-opioid pathways.
However, the influence of biological sex on EIH remains unclear, and understanding potential differences between men and women could have important implications for exercise prescription in clinical and healthy populations.
This quasi-experimental study will include healthy male and female participants aged 18-65 years. Participants will undergo a single session of aerobic exercise on a lower-limb cycle ergometer at 70% heart rate reserve for 30 minutes.
Pressure pain thresholds will be assessed using a validated digital pressure algometer at:
- Quadriceps muscle (local site)
- Lateral epicondyle region (remote site)
Measurements will be performed at three time points:
- Pre-exercise
- Immediately post-exercise
- 30 minutes post-exercise
The primary analysis will compare changes in pressure pain thresholds between men and women using ANCOVA models adjusting for baseline values.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male participants | Experimental | Behavioral: Aerobic exercise using cycle ergometerParticipants will perform a 30-minute aerobic exercise protocol on a lower-limb cycle ergometer at 70% heart rate reserve, including warm-up and cool-down periods. |
| Female participants | Experimental | Behavioral: Aerobic exercise using cycle ergometerAerobic exercise using lower-limb cycle ergometer. Participants will perform the same aerobic exercise protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male and female adults
- Age between 18 and 65 years
- Able to perform moderate-to-vigorous aerobic exercise
- Able to understand study procedures
- Cleared for exercise participation using the Physical Activity Readiness Questionnaire (PAR-Q).
Key exclusion criteria (5 listed)
- Cardiovascular, respiratory, neurological, or metabolic diseases contraindicating exercise
- Current musculoskeletal pain or injury
- Analgesic medication use within 24 hours prior to testing
- Vigorous exercise within 24 hours prior to testing
- Any contraindication to aerobic exercise
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 |
|---|---|---|
| Aerobic exercise using cycle ergometerParticipants will perform a 30-minute aerobic exercise protocol using a lower-limb cycle ergometer at 70% heart rate reserve. The protocol includes: * 5-minute warm-up * 20-minute exercise at target intensity * 5-minute cool-down Heart rate will be monitored continuously using a validated heart rate monitor. | Behavioural | Female participants, Male participants |
Primary outcome
Pressure Pain Threshold at Quadriceps
Time frame: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise
Pressure pain threshold measured using a digital pressure algometer at the quadriceps muscle.
1 secondary outcome
Pressure Pain Threshold at Lateral Epicondyle
Time frame: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- BackgroundAwali, A., Nevsimal, R., O'Melia, S., Alsouhibani, A., & Bement, M. Hoeger. (2019). (305) The Contribution of Experimental Pain to the Sex Differences in Exercise-Induced Hypoalgesia. The Journal of Pain, 20(4, Supplement), S50. https://doi.org/10.1016/j.jpain.2019.01.462 Belavy, Daniel L., Oosterwijck, Jessica Van, Clarkson, Matthew, Dhondt, Evy, Mundell, Niamh L., Miller, Clint T., & Owen, Patrick J. (2021). Pain sensitivity is reduced by exercise training: Evidence from a systematic review and meta-analysis. Neuroscience & Biobehavioral Reviews, 120, 100-108. https://doi.org/10.1016/J.NEUBIOREV.2020.11.012 Cano-Climent, Antoni, Oliver-Roig, Antonio, Cabrero-García, Julio, Vries, Jolanda de, & Richart-Martínez, Miguel. (2017). The Spanish version of the Fatigue Assessment Scale: Reliability and validity assessment in postpartum women. PeerJ, 5(9). https://doi.org/10.7717/PEERJ.3832 Castañeda, Francisco Javier Rubio, Aznar, Concepción Tomás, & Baquero, Carmen Muro. (2017). Validity, Reliability and Associated Factors of the International Physical Activity Questionnaire Adapted to Elderly (IPAQ-E). Revista Espanola de Salud Publica, 91. Chesterton, Linda S., Sim, Julius, Wright, Christine C., & Foster, Nadine E. (2007). Interrater Reliability of Algometry in Measuring Pressure Pain Thresholds in Healthy Humans, Using Multiple Raters. The Clinical Journal of Pain, 23(9), 760-766. https://doi.org/10.1097/AJP.0b013e318154b6ae Day, M. L., McGuigan, M. R., Brice, G., & Foster, C. (2004). Monitoring exercise intensity during resistance training using the session RPE scale. Journal of Strength and Conditioning Research, 18(2), 353-358. https://doi.org/10.1519/R-13113.1 Faul, Franz, Erdfelder, Edgar, Lang, Albert-Georg, & Buchner, Axel. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. https://doi.org/10.3758/BF03193146 Kinser, Ann M., Sands, William A., & Stone, M
- Individual participant dataSharing planned: Yes. Data regarding the principal and secondary outcomes: Pressure Pain Thresholds for the quadriceps and epicondyle sites.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise using cycle ergometer in people with Healthy Adult, run by Centro Universitario La Salle at 1 site in Spain.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Mar 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Álvaro Reina-Varona, MSc. ((+34) 91 740 19 80 ext. 506, alvaro.reina@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold at Quadriceps (time frame: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427979, which also lists 1 linked publication.
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 18 Mar 2026.