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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Álvaro Reina-Varona, MSc. contact

(+34) 91 740 19 80 ext. 506

alvaro.reina@lasallecampus.es

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

Other trials in Spain

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 groups in NCT07427979
Study groupRoleWhat they receive
Male participantsExperimentalParticipants 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 participantsExperimentalAerobic 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.

  1. 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)

  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.

  1. First posted23 Feb 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 Jul 2026 (estimated)

Resources

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)
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

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.

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