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TrainingNCT07105410

Hypoalgesic Effects of Exercise and Training of Different Modalities

A study testing Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-wave, Aim #2: The hypoalgesic effects of acute exercise of different modalities and Aim #3: The hypoalgesic effects of chronic training of different modalities in people with Training and Exercise, run by Faculdade de Motricidade Humana at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Further research is needed to explore the analgesic effects of post-acute and chronic exercise and if effects are partially dependent on lower H-reflex/V-wave inhibition by group III and IV muscle afferents desensitization. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Training, Exercise, Fatigue
What is being tested?
Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-wave, Aim #2: The hypoalgesic effects of acute exercise of different modalities and Aim #3: The hypoalgesic effects of chronic training of different modalities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePortugal
Study dates
1 Jan 2022to 30 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 - 35 years males
  • Healthy (health status determined from a health-screening questionnaire performed at study admission)
  • Normal arterial blood pressure (ABP) (cut-off values for systolic arterial pressure (SAP) and diastolic arterial pressure (DAP) of ≤ 120/80 mmHg)

Who cannot join

  • Neurologic disease
  • Metabolic disease
  • Cardiovascular disease
  • Respiratory disease
  • Musculoskeletal issues in the 3 previous months limiting exercise performance
  • Taking any chronic medications for the treatment of pain or had any pain related condition

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Faculdade de Motricidade Humana

    Lisbon, 2685-224

Other trials in Portugal

About this study

Official title: The Influence of Nociception on Exercise Induced Fatigue: the Analgesic Role of Acute Exercise and Long-term Training of Different Exercise Modalities

Further research is needed to explore the analgesic effects of post-acute and chronic exercise and if effects are partially dependent on lower H-reflex/V-wave inhibition by group III and IV muscle afferents desensitization. In addition, it is important to note that the available research examining the interaction between exercise (acute and chronic) and pain did not compare the effect of different exercise modalities. Moreover, since discharge rate of III and IV afferents is highly dependent on specific task-metabolic requirements, it is relevant to determine if exercise modality differentially modulates the possible analgesic response via metaboreflex desensitization.

Therefore, with this project, the investigators aim at exploring the influence of experimentally induced metaboreflex activation (group III and IV afferents) (maintained submaximal isometric contraction followed by blood-flow occlusion - post-exercise circulatory occlusion (PECO)) Vs. a control condition (no isometric contraction nor blood flow occlusion), on H-reflex recruitment curve and V-wave excitability (aim #1). Since the activation of group III/IV afferents can inhibit the corticospinal pathway, the investigators hypothesize that the normalized maximal amplitude of H- and V-wave and the slope of the ascending limb of the H-recruitment curve will decrease with metaboreflex activation (during PECO). Additionally, the investigators intend to examine the acute impact of different lower-limb exercise regimens (aerobic, anaerobic and dynamic resistance) on pain sensitivity (by the application of a foot cold pain tolerance test, by determining pressure pain threshold of exercising and non-exercising muscles and through self-reported leg ischemic pain ratings (0-10 Cook scale) - during PECO) (aim #2). Participants are also asked to mark the intensity of cold pain sensation using a visual analogue scale (VAS) with a horizontal line of 100mm, every 30 s of testing.This will allow the investigators to investigate the analgesic role of different acute exercise paradigms through possible metaboreflex desensitization given by altered neuromuscular responses at post-exercise time point (attenuated inhibition of H-reflex and V-wave amplitude during PECO). Also, once past research has shown that muscle metaboreflex activation reduces the sensitivity of the baroreflex, the investigators will measure arterial pressure (AP) and heart rate variability (HRV) during cold test and AP during ischemic testing. Despite all exercise modalities could enhance reducing pain sensibility after exercise, the investigators hypothesize that resistance and anaerobic exercise stimuli will enhance pain threshold/tolerance and reduced pain ratings via metaboreflex desensitization compared to that seen with endurance exercise (attenuated increase of AP and sympathetic component of HRV during cold pressor test and attenuated increase of AP during ischemic pain test). Finally, the investigators intend to explore the impact of long-term aerobic, anaerobic and resistance training on pain sensibility, using the same tests of aim #2 (aim #3). The investigators hypothesize that chronic EIH will be of greater magnitude after anaerobic and resistance exercise training vs. endurance training. This will be related with attenuated inhibition of H-reflex and V-wave amplitude measured during PECO and attenuated increase of AP and sympathetic component of HRV during metaboreflex activation after those training modalities. Nevertheless, the investigators expect to see an increased motor performance in all training regimens via heightened H-reflex (aerobic and anaerobic groups) and V-wave (resistance group) excitability.

Being tested
Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-wave, Aim #2: The hypoalgesic effects of acute exercise of different modalities, Aim #3: The hypoalgesic effects of chronic training of different modalities
Keywords
hypoalgesia, pain
Medical subject headings
Motor Activity, Fatigue, Bites and Stings, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-waveOther

    Aim #1 follows a randomized and crossover design in which 16 young and healthy males are evaluated during thigh circulatory occlusion performed after a submaximal isometric plantar flexion contraction (PECO day). In the other session, participants are evaluated during free-flow conditions and without previous fatiguing contraction (no-PECO day). In PECO day, participants complete a 3-min contraction at 40% of maximal force. Then, for testing, blood flow from lower-leg is blocked during 4 min, by an inflatable cuff around the ipsilateral thigh before task termination, during which H- reflex is tested. At the end of recordings, the cuff is deflated. Participants ware allowed to rest for 5-10 min. Then, they are requested to perform a new 3 min contraction with the cuff being inflated before task termination. The cuff remains inflated for ~ 2 min during which V-wave recordings are obtained. In both days, leg pain intensity is reported by participants and brachial AP is measured.

  • Aim #2: The hypoalgesic effects of acute exercise of different modalitiesOther

    Aim #2 follows a randomized and crossover-controlled design, consisting on two experimental sessions. 24 healthy male (all diferent from Experiment 1) are randomly allocated to one of the following exercising regimens: aerobic, anaerobic or dynamic resistance (8 participants for each exercise group). In one of the experimental days, participants are evaluated for pain sensitivity and neuromuscular responses both before and after a lower-limb acute exercise protocol (exercise day) and in the other day before and after 15 min of quiet rest (non-exercise day). In both sessions, participants are evaluated for rectus femoris, upper trapezius and biceps brachiis muscles pressure pain threshold, followed by the application of a cold pain tolerance test on the foot. The intensity of pain is reported by a 0-100mm VAS and AP and HRV continously measured. Then, participants are tested for H-reflex and V-wave excitability during PECO, with leg pain intensity (0-10) and brachial AP recorded.

  • Aim #3: The hypoalgesic effects of chronic training of different modalitiesOther

    Aim #3 follows a randomized-controlled design. 32 healthy male (all the 24 participants from Experimental 2 plus 8 new subjects) are randomly allocated to one of the following groups: aerobic, anaerobic, dynamic resistance training and no-training (control) (8 participants for each group). Each intervention group perform 6 weeks of exercise training (3x week). Participants allocated to each training group are evaluated before and after training (2 assessment days in each time-point). On one day participants are tested for pressure pain threshold and cold pain tolerance with concomitant measures of pain ratings (0-100mm VAS), AP and HRV. The influence of metaboreflex activation on H-reflex and V-wave is also measured (during PECO). In addition, during PECO ischemic pain rating and AP are obtained. On another day, participants are evaluated for motor performance (maximal oxygen uptake, maximal voluntary contraction and peak power) and neuromuscular adaptations (i.e. H-reflex and V-wave)

Study groups in NCT07105410
Study groupRoleWhat they receive
PECO and No-PECOExperimentalNot described
Receives: Other: Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-wave
Aerobic, Anaerobic and Dynamic Resistance ExerciseExperimentalNot described
Receives: Other: Aim #2: The hypoalgesic effects of acute exercise of different modalities
Aerobic, Anaerobic, Dynamic Resistance Training and Control GroupExperimentalNot described
Receives: Other: Aim #3: The hypoalgesic effects of chronic training of different modalities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. H-reflex

    With soleus electromyographic recording electrode (Delsys) and electrical stimulation of the tibial nerve (Stimsola) the H-reflex recruitment curve parameters (spinal excitability) will be obtained in a 4-min protocol

    Measured: During PECO and No-PECO conditions (aim #1); Pre-post acute exercise during PECO (aim #2); Pre-post 6 weeks of training during PECO (aim #3)

  2. V-wave

    With soleus electromyographic recording electrode (Delsys) and electrical stimulation of the tibial nerve (Stimsola) the V-wave parameters (spinal and supraspinal excitability) will be obtained

    Measured: During PECO and No-PECO conditions (aim #1); Pre-post acute exercise during PECO (aim #2); Pre-post 6 weeks of training during PECO (aim #3)

  3. Ischemic pain ratings

    Participants will be asked to rate their leg pain intensity twice at the 4-min H-reflex protocol (at 2nd and 4th min of the procedure) using a Cook pain sale (0-10). In the scale, 0 represents no pain while 10 represents the worst possible pain

    Measured: During PECO and No-PECO conditions (aim #1); Pre-post acute exercise during PECO (aim #2); Pre-post 6 weeks of training during PECO (aim #3)

  4. Arterial blood pressure

    Brachial arterial pressure will be measured twice at the 4-min H-reflex protocol (at 2nd and 4th min of the procedure) by an automated equiment (Tango SunTech Medical)

    Measured: During PECO and No-PECO conditions (aim #1); Pre-post acute exercise during PECO (aim #2); Pre-post 6 weeks of training during PECO (aim #3)

  5. Pressure pain threshold

    It will be assessed with an analogue algometer (FDK 60, Wagner Instruments) (in rectus femoris, upper-trapezius and biceps brachiis muscles). It measures the kg of force at the time participants report they are feeling pain intead of pressure

    Measured: Pre-post acute exercise (aim #2); Pre-post 6 weeks of training (aim #3)

  6. Cold pain tolerance

    It will be assessed with participants immersing their right foot into a container with cold water between 0 and 2ºC. It measures the time participants can endure the cold painful stimuli

    Measured: Pre-post acute exercise (aim #2); Pre-post 6 weeks of training (aim #3)

  7. Cold pain ratings

    While participants immerse their right foot into a container with cold water between 0 and 2ºC, they will beasked to rate the intensity of pain they perceived each minute by writing in a visual analogue scale (0-100mm) that pain intensity. 0 is considered no-pain and 100 the worst possible pain

    Measured: Pre-post acute exercise (aim #2); Pre-post 6 weeks of training (aim #3)

  8. Heart rate variability during cold pain testing

    It will be measured continuosly during the time participants have their foot in cold water using a heart rate monitor (Polar H10)

    Measured: Pre-post acute exercise (aim #2); Pre-post 6 weeks of training (aim #3)

  9. Arterial blood pressure during cold pain testing

    It will be measured each minute during the time participants have their foot in cold water using an automatic equipment (Tango SunTech Medical)

    Measured: Pre-post acute exercise (aim #2); Pre-post 6 weeks of training (aim #3)

  10. Maximal oxygen uptake

    For the aerobic group, it will be determined in a treadmill graded exercise testing using a gas analyses system (Metamax, Cortex)

    Measured: Pre-post 6 weeks of training (aim #3)

  11. Peak power

    For the anaerobic group, it will be determined with a 30-s Wingate all-out test (Monark cycloergometer)

    Measured: Pre-post 6 weeks of training (aim #3)

  12. Maximal voluntary isometric contraction

    For the dynamic resistance group, it will be determined for the knee extensors muscles using an isokinetic dynamometer (Biodex)

    Measured: Pre-post 6 weeks of training (aim #3)

  13. H-reflex after training

    With soleus electromyographic recording electrode (Delsys) and electrical stimulation of the tibial nerve (Stimsola) the H-reflex recruitment curve parameters (spinal excitability) will be obtained

    Measured: Pre-post 6 weeks of training (aim #3)

  14. V-wave after training

    With soleus electromyographic recording electrode (Delsys) and electrical stimulation of the tibial nerve (Stimsola) the V-wave parameters (spinal and supraspinal excitability) will be obtained

    Measured: Pre-post 6 weeks of training (aim #3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start1 Jan 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105410
Sponsor's protocol ID
CEIFMH Nº33/2021
Status last verified
Jul 2025
First submitted
17 Jul 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aim #1: The effect of post-exercise circulatory occlusion on H-reflex and V-wave, Aim #2: The hypoalgesic effects of acute exercise of different modalities and Aim #3: The hypoalgesic effects of chronic training of different modalities in people with Training and Exercise, run by Faculdade de Motricidade Humana at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

H-reflex (time frame: During PECO and No-PECO conditions (aim #1); Pre-post acute exercise during PECO (aim #2); Pre-post 6 weeks of training during PECO (aim #3)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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