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Clinical Trials/NCT07427979
NCT07427979
Not yet recruiting
Not Applicable

Sex Differences in Exercise-Induced Hypoalgesia Following Aerobic Exercise Using a Lower-Limb Cycle Ergometer: A Quasi-Experimental Study

Centro Universitario La Salle1 site in 1 country30 target enrollmentStarted: March 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Centro Universitario La Salle
Enrollment
30
Locations
1
Primary Endpoint
Pressure Pain Threshold at Quadriceps

Overview

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.

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

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Aerobic exercise using cycle ergometer (Behavioral)

Female participants

Experimental

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

Intervention: Aerobic exercise using cycle ergometer (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pressure Pain Threshold at Lateral Epicondyle(Pre-exercise, immediately post-exercise, and 30 minutes post-exercise)

Investigators

Sponsor
Centro Universitario La Salle
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Álvaro Reina Varona

Principal Investigator

Centro Universitario La Salle

Study Sites (1)

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