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

5 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

27

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Miguel Delicado Miralles, Physiotherapy
  • Numer telefonu: +34 679788377
  • E-mail: mdelicado@umh.es

Lokalizacje studiów

    • ALICANTE
      • Alicante, ALICANTE, Hiszpania, 03550
        • Universidad Miguel Hernández
        • Kontakt:
          • Miguel Delicado Miralles, Physiotherapy
          • Numer telefonu: +34 679788377
          • E-mail: mdelicado@umh.es

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Pozorny komparator: Kontrola
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
Eksperymentalny: 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
Eksperymentalny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain pressure threshold
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Kinematic measures
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2027

Ukończenie studiów (Szacowany)

30 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

11 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • DPC.MDM.240801

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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