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The Role of Fatigue Associated With Strength Training in Exercise-induced Hypoalgesia (FATIGUEIH)

5 mei 2026 bijgewerkt door: Jaime Gascón Jaen, Universidad Miguel Hernandez de Elche

The Role of Fatigue Associated With Different Protocols of Strength Training in Exercise-induced Hypoalgesia: A Randomized Crossover Trial

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

27

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Miguel Delicado Miralles, Physiotherapy
  • Telefoonnummer: +34 679788377
  • E-mail: mdelicado@umh.es

Studie Locaties

  • Spanje
    • ALICANTE
      • Alicante, ALICANTE, Spanje, 03550
        • Universidad Miguel Hernández
        • Contact:
          • Miguel Delicado Miralles, Physiotherapy
          • Telefoonnummer: +34 679788377
          • E-mail: mdelicado@umh.es

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Healthy, asymptomatic subjects
  • Being physically active

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Controle
Gedragsmatig: Seated leg extension: control
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
Experimenteel: Low fatigue
Gedragsmatig: Seated leg extension machine: low fatigue
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
Experimenteel: High fatigue
Gedragsmatig: Seated leg extension machine: high 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain pressure threshold
Tijdsspanne: Baseline, immediately post-exercise, 30 minutes after exercise
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
Tijdsspanne: Baseline, immediately post-exercise, 30 minutes after exercise

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)
Tijdsspanne: Immediately after each set of the training session
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)
Tijdsspanne: 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.
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)
Tijdsspanne: Immediately after each set of the training session.
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
Tijdsspanne: Baseline, immediately post-exercise, 30 minutes after exercise
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Kinematic measures
Tijdsspanne: 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).
Angular position (º), velocity(º/s) and acceleration(º/s^2) of the machine's pad during the exercise will be recorded using an accelerometer (BWT901CL, WitMotion Shenzhen Co., Ltd).
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
Tijdsspanne: Prior to each exercise session.
Data regarding fatigue, sleep quality, DOMS, stress levels and mood will be tracked every session using a Wellness questionnaire where 5 is the best outcome and 1 is the worst for each individual item.
Prior to each exercise session.
Fitness level
Tijdsspanne: Baseline (Day 1)
The subject's level of physical activity will be collected via the IPAQ (International Physical Activity Questionnaire), which accounts for every physical activity performed throughout the week prior to taking the questionnare and converts them to METs (Metabolic Equivalent of a Task). Higher values indicate higher degree of fitness, and 0 being the floor (zero physical activity).
Baseline (Day 1)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Miguel Hernandez de Elche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 mei 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DPC.MDM.240801

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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