NCT07427979

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 17, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Exercise-Induced HypoalgesiaSex differencesAerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold at Quadriceps

    Pressure pain threshold measured using a digital pressure algometer at the quadriceps muscle.

    Pre-exercise, immediately post-exercise, and 30 minutes post-exercise

Secondary Outcomes (1)

  • Pressure Pain Threshold at Lateral Epicondyle

    Pre-exercise, immediately post-exercise, and 30 minutes post-exercise

Study Arms (2)

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.

Behavioral: Aerobic exercise using cycle ergometer

Female participants

EXPERIMENTAL

Aerobic exercise using lower-limb cycle ergometer. Participants will perform the same aerobic exercise protocol.

Behavioral: Aerobic exercise using cycle ergometer

Interventions

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.

Female participantsMale participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Superior de Estudios Universitarios La Salle

Madrid, Madrid, 28023, Spain

Location

Related Publications (1)

  • 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

    BACKGROUND

Central Study Contacts

Álvaro Reina-Varona, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

March 15, 2026

Primary Completion

May 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data regarding the principal and secondary outcomes: Pressure Pain Thresholds for the quadriceps and epicondyle sites.

Shared Documents
STUDY PROTOCOL, SAP

Locations