NCT07577622

Brief Summary

Strength exercise is an active and dynamic activity that involves applying force against a resistance. This produces fatigue, seen as a reduced ability to apply force during and after the exercise, and perceived effort, which is a person's subjective feeling of how hard they are working. Strength exercise can also be used for therapy, as it has many benefits for different parts of the body. One of these is changing how the individual feels pain. It has been shown that doing strength exercises can reduce pain perception, a phenomenon called exercise-induced hypoalgesia (EIH), although the exact physical reasons and the amount of exercise needed to cause this effect are not yet known. One of the most studied exercises in this area is the leg extension machine. This is a specific exercise where the legs move freely (open kinetic chain) and the machine guides the movement, which helps keep things stable and limits the effect of other factors. It is usually used to strengthen and grow the muscles in the front of the thigh, especially the quadriceps, but it can also be used to study the effects on EIH. The main goal of this study is to see if fatigue and perceived effort during strength exercise are important for EIH to happen in healthy people. Participants will complete 3 sessions, at least 7 days apart. These will include a control session and 2 sessions designed to show different levels of fatigue. Before, during, and after the sessions, the investigators will measure pain sensitivity, isometric strength, and perceived effort. Also, there will be a test to find the maximum weight for 10 repetitions and several questionnaires to collect basic info (sex, age, height...), weekly physical activity, experience with strength training, and other factors like sleep quality, stress, and mood. All this information will be completely anonymous when the study results are shared.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started May 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 22, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

April 22, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

FatigueExerciseHypoalgesiaStrength trainingHealthy adultleg extension

Outcome Measures

Primary Outcomes (6)

  • Pain pressure threshold

    Pain pressure threshold measured with an analogic algometer (Baseline Dolorimeter, MVS In Motion SL, Belgium), in kilograms. These measurements will be taken at a local level (on one of the thighs, over the rectus femoris of the quadriceps, at the midpoint between the pelvic surface and the patella) and at a distance (on the neck over the belly of one of the upper trapezius muscles, at the midpoint between the surface of C7 and the acromion). The pressure will be applied at a rate of 1kg/s and the patient will be instructed to notify the first instance of pain.

    Baseline, immediately post-exercise, 30 minutes after exercise

  • Pressure-evoked pain

    Pain evoked by a 6kg pressure exerted with an analogic algometer (Baseline Dolorimeter, MVS In Motion SL, Belgium), at a rate of 1kg/s, measured with a numeric rating scale where zero is equivalent to no pain and 10 indicates the worst possible pain. These measurements will be taken at a local level (on one of the thighs, over the rectus femoris of the quadriceps, at the midpoint between the pelvic surface and the patella) and at a distance (on the neck over the belly of one of the upper trapezius muscles, at the midpoint between the surface of C7 and the acromion).

    Baseline, immediately post-exercise, 30 minutes after exercise

  • RPE (Rating of Perceived Exertion)

    Perceived exertion was measured on OMNI-Resistance exercise Scale where 0 is equivalent to no effort and 10 indicates maximal exertion.

    Immediately after each set of the training session

  • sRPE (Session rating of perceived exertion)

    Session Perceived Exertion was measured on a scale where 0 is equivalent to no effort and 10 indicates maximal exertion.

    Monitoring will take place 30 minutes after the final set, ensuring that the exertion from the last set does not interfere with the overall session RPE.

  • Repetitions in Reserve (RIR)

    Using the ERF (Estimated Repetitions to Failure) scale where 0 is equivalent to maximal effort or muscular failure, and higher numbers indicate lower effort. For this purpose, subjects will be asked how many more repetitions they believe they could have performed after each set.

    Immediately after each set of the training session.

  • Muscle fatigue

    This will be monitored taking into account objective variables (not dependent on the patient's subjective report), through isometric knee extension action tests measured by dynamometry using a portable load cell (Model 620 Tedea-Huntleigh, Vishay Precision Group Inc., Holon, Israel) and Chronojump software (Chronojump Bosco System, Barcelona, Spain). The variables used are the maximal voluntary isometric contraction (MVIC) measured in Newtons (N) and the Rate of Force Development (RFD) which calculates the slope of the force-time curve.

    Baseline, immediately post-exercise, 30 minutes after exercise

Secondary Outcomes (3)

  • Kinematic measures

    During each set of the exercise intervention in all 3 sessions (3 or 6 sets depending on each arm). Total measurement time approximately 3 minutes during a single experimental session (as the device will stop recording during rest periods between sets).

  • Wellness

    Prior to each exercise session.

  • Fitness level

    Baseline (Day 1)

Study Arms (3)

Control

SHAM COMPARATOR
Behavioral: Seated leg extension: control

Low fatigue

EXPERIMENTAL
Behavioral: Seated leg extension machine: low fatigue

High fatigue

EXPERIMENTAL
Behavioral: Seated leg extension machine: high fatigue

Interventions

Seated leg extension machine using 10RM external load for 6 sets of 5 repetitions with180 seconds rest between sets and a cadence of 1:2 second concentric:eccentric

Low fatigue

Seated leg extension machine using 10RM external load for 3 sets of 10 repetitions with 180 seconds rest between sets and a cadence of 1:2 second concentric:eccentric

High fatigue

Seated leg extension machine using no external load for 6 sets of 5 repetitions with 180 seconds rest between sets and a cadence of 1:2 second concentric:eccentric

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, asymptomatic subjects
  • Being physically active

You may not qualify if:

  • Experiencing episodes of acute pain in any part of the body.
  • Having chronic pain or a recent history of chronic pain conditions considered resolved within the last 6 months.
  • Having a serious illness or inability to perform moderate or intense physical activity.
  • Having taken pain relievers, fever reducers, anti-inflammatory drugs (NSAIDs), steroids, opioids, or similar medications in the 24 hours before a session.
  • Having consumed alcohol or other psychoactive substances, caffeine, or other stimulants in the 24 hours before a session.
  • Having performed tiring physical activity or strength exercise in the 24 hours before a session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Miguel Hernández

Alicante, ALICANTE, 03550, Spain

Location

Related Publications (3)

  • Hogge R, Mascheri M, Shurik D, Hanney WJ, Anderson AW. High-Fatigue Dynamic Resistance Exercise Induces Significant Hypoalgesia Effect. J Strength Cond Res. 2025 Feb 1;39(2):165-172. doi: 10.1519/JSC.0000000000004985. Epub 2024 Nov 26.

    PMID: 39590221BACKGROUND
  • Vaegter HB, Jones MD. Exercise-induced hypoalgesia after acute and regular exercise: experimental and clinical manifestations and possible mechanisms in individuals with and without pain. Pain Rep. 2020 Sep 23;5(5):e823. doi: 10.1097/PR9.0000000000000823. eCollection 2020 Sep-Oct.

    PMID: 33062901BACKGROUND
  • Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26.

    PMID: 32599154BACKGROUND

MeSH Terms

Conditions

FatigueMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Miguel Delicado Miralles, Physiotherapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The Statistician will also be masked
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double-blind randomized crossover controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asociated Professor

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 11, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations