- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07577622
The Role of Fatigue Associated With Strength Training in Exercise-induced Hypoalgesia (FATIGUEIH)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Miguel Delicado Miralles, Physiotherapy
- Phone Number: +34 679788377
- Email: mdelicado@umh.es
Study Locations
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ALICANTE
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Alicante, ALICANTE, Spain, 03550
- Universidad Miguel Hernández
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Contact:
- Miguel Delicado Miralles, Physiotherapy
- Phone Number: +34 679788377
- Email: mdelicado@umh.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
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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
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Experimental: Low fatigue
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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
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Experimental: High fatigue
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold
Time Frame: 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.
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Baseline, immediately post-exercise, 30 minutes after exercise
|
|
Pressure-evoked pain
Time Frame: 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
|
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RPE (Rating of Perceived Exertion)
Time Frame: Immediately after each set of the training session
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Perceived exertion was measured on OMNI-Resistance exercise Scale where 0 is equivalent to no effort and 10 indicates maximal exertion.
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Immediately after each set of the training session
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sRPE (Session rating of perceived exertion)
Time Frame: 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.
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Session Perceived Exertion was measured on a scale where 0 is equivalent to no effort and 10 indicates maximal exertion.
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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.
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Repetitions in Reserve (RIR)
Time Frame: Immediately after each set of the training session.
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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.
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Immediately after each set of the training session.
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Muscle fatigue
Time Frame: Baseline, immediately post-exercise, 30 minutes after exercise
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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.
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Baseline, immediately post-exercise, 30 minutes after exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinematic measures
Time Frame: 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).
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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).
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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).
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Wellness
Time Frame: Prior to each exercise session.
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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.
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Prior to each exercise session.
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Fitness level
Time Frame: Baseline (Day 1)
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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).
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Baseline (Day 1)
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPC.MDM.240801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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