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Exercise Induced HypoalgesiaNCT07290465

Pain Perception and Exercise-Induced Hypoalgesia Across Circadian Rhythms

A study testing High-Intensity Functional Training (HIFT) and Supervised Deep Breathing in people with Exercise Induced Hypoalgesia and Circadian Rhythm, run by Medipol University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized crossover clinical trial is to investigate whether exercise-induced hypoalgesia (EIH) is influenced by circadian rhythm in healthy adults aged 18-40 years. The main questions it aims to answer are: Does the time of day (morning vs. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
High-Intensity Functional Training (HIFT) and Supervised Deep Breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jan 2026to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy participants
  • age 18 to 40 years
  • good level of English that allow the enrolled participant to provide informed consent and complete the questionnaires provided
  • being categorized as "moderate" in the International Physical Activity Questionnaire (IPAQ)

Who cannot join

  • inability to report pain intensity reliably
  • consumption of narcotics or tobacco products
  • regularly taking pain medications and analgesics
  • pregnant or planning to get pregnant
  • surgery within the last 12 months
  • acute or chronic pain conditions
Show all 13Show fewer
  • uncontrolled hypertension
  • cardiovascular diseases, pulmonary diseases, neurological diseases with significant changes in somatosensory and pain perception, metabolic diseases, serious systemic diseases or conditions that restrict normal daily activities, inflammatory conditions (e.g. rheumatoid arthritis), or orthopedic injuries
  • intolerable pain during the pain perception test
  • serious psychiatric conditions (e.g., schizophrenia and bipolar disorder) or psychological disorders (e.g., depression) that may affect pain thresholds (16).
  • Severe sleep disorders and circadian rhythm disturbances
  • BMI > 30
  • serious fatigue or delayed-onset muscle soreness (9) at least 24 h after exercise sessions or a sudden change in activity for more than one week

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatema Mohamed Soliman, PT, MSc (Cand.) contact

+90 537 736 20 79 ext. +20 15 0156870

pt.fatemasoliman@gmail.com

Aliaa Salem Menshawi, PT, MSc (Cand.) contact

+905527304660 ext. +96550268508

aliaamenshawi@gmail.com

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Beykoz, 34810

    Fatema Mohamed Soliman, PT, MSc (Cand.), +90 537 736 20 79 ext. +20 15 0156870, fatema.mohammed200088@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Exploring Pain Perception Through Exercise-Induced Hypoalgesia Across Circadian Rhythms for Healthy Participants

The goal of this randomized crossover clinical trial is to investigate whether exercise-induced hypoalgesia (EIH) is influenced by circadian rhythm in healthy adults aged 18-40 years.

The main questions it aims to answer are:

  • Does the time of day (morning vs. evening) influence changes in pain perception following exercise?
  • Do chronotype, sex, or stimulation site (bony vs. muscular) alter the magnitude of this effect?

Participants will:

  • Complete questionnaires
  • Undergo quantitative sensory testing
  • Attend both morning and evening sessions in randomized crossover order
Read the detailed description

Exercise-induced hypoalgesia (EIH) is a temporary reduction in pain sensitivity following physical activity. High-intensity functional training (HIFT) has been shown to produce EIH, yet the influence of circadian rhythms on this response is not well established. Circadian timing regulates physiological processes, including pain modulation, and may contribute to variability in exercise-related analgesia.

This randomized crossover trial will examine whether time of day (morning vs. evening) affects EIH in healthy adults. It will also explore the relationship between an individual's chronotype, the efficacy of EIH and the difference in magnitude between men and women, the difference in effect between bony and muscular landmarks for pressure stimulus application.

Null Hypothesis (H0) : Circadian rhythm has no significant influence on the efficacy of exercise-induced hypoalgesia (EIH), as measured by changes in pain perception before and after high intensity functional training at different times of day (morning vs. evening).

Alternative Hypothesis (H1): Circadian rhythm significantly influences the efficacy of exercise-induced hypoalgesia (EIH), with differences in pain perception before and after high intensity functional training depending on the time of day (morning vs. evening).

Each participant will complete both morning and evening sessions in randomized order, separated by ≥72 hours. Participants who completed the morning sessions will cross over to the evening sessions and vice versa. Within each session, they will perform a 12-minute supervised deep breathing control condition and a 12-minute HIFT intervention, separated by a 30-minute rest.

Being tested
High-Intensity Functional Training (HIFT), Supervised Deep Breathing
Keywords
Exercise-Induced Hypoalgesia, Pain Perception, Circadian Rhythm, Chronotype, Healthy Participants, High-Intensity Functional Training, Supervised Deep Breathing, Pressure Pain Threshold (PPT), Pain pressure tolerance threshold (PPTol), Quantative Sensory Testing, Bony Landmarks, Muscular Landmarks, Physical Therapy, Randomized Control Trial, Crossover, Pain Management
Medical subject headings
Agnosia

What participants receive

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

  • High-Intensity Functional Training (HIFT)Behavioural

    A 12-minute, instructor-led HIFT protocol delivered via the same video to all participants. After a 5-minute warm-up, participants perform six exercises targeting major muscle groups. The exercises are 4 lunges followed by one push-up, 10 high knees followed by 10 shuffles, burpees, squat jumps, skaters, and plank up-downs. Each exercise is done for 40 seconds then 20 seconds rest. The cycle repeats twice for a total of 12 minutes. Rate of Perceived Exertion (Borg scale) is recorded at baseline, post-warmup, during each rest interval, and immediately post-exercise. A physiotherapist supervises performance, ensures correct technique, and enforces safety and target intensity while motivating and encouraging the participant.

  • Supervised Deep BreathingBehavioural

    A 12-minute deep breathing session delivered via a prerecorded audio and supervised by a physiotherapist. The breathing rhythm includes inhaling for 4 seconds and exhaling for 6 seconds for a total 1 minute, followed by 1 minute of normal breathing. This cycle is repeated six times for a total duration of 12 minutes. Participants lie supine in a comfortable position and wear headphones. A self-reported Rate of Perceived Relaxation (RPR, 0-10) is recorded before and after. This serves as a non-exercise control to account for relaxation and attention effects.

Study groups in NCT07290465
Study groupRoleWhat they receive
Morning ChronotypeExperimentalParticipants classified as morning chronotype using the Munich Chronotype Questionnaire (MCTQ) will attend both a morning session and an evening session in randomized order with at least 72 hours between visits. Within each session the participant completes both a 12-minute supervised deep-breathing control condition and a 12-minute High-Intensity Functional Training (HIFT) intervention, separated by a 30-minute break to minimize carryover effects. Pain perception is assessed before and after each condition.
Receives: Behavioral: High-Intensity Functional Training (HIFT); Behavioral: Supervised Deep Breathing
Evening ChronotypeExperimentalParticipants classified as evening chronotype using the Munich Chronotype Questionnaire (MCTQ) will attend both a morning session and an evening session in randomized order with at least 72 hours between visits. Within each session the participant completes both a 12-minute supervised deep-breathing control condition and a 12-minute High-Intensity Functional Training (HIFT) intervention, separated by a 30-minute break to minimize carryover effects. Pain perception is assessed before and after each condition.
Receives: Behavioral: High-Intensity Functional Training (HIFT); Behavioral: Supervised Deep Breathing

What is being measured

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

  1. Pressure Pain Threshold (PPT)

    Pressure Pain Threshold (PPT) will be measured using an algometer at standardized bony and muscular landmarks. Pressure Pain Threshold (PPT) is defined as the minimal pressure at which a participant first perceives pain. Changes in Pressure Pain Threshold (PPT) will be used to assess the magnitude of exercise-induced hypoalgesia (EIH).

    Unit: kg/cm²

    Measured: Baseline (0 minute before intervention) and immediately post-intervention (within 2 minutes) Measured in both high intensity functional training (HIFT) and supervised deep-breathing conditions during each morning and evening session

  2. Pressure Pain Tolerance (PPTol)

    Pressure Pain Tolerance (PPTol) will be measured using an algometer at standardized bony and muscular landmarks. Pressure Pain Tolerance (PPTol) is defined as the maximal pressure the participant is willing to tolerate. Changes in Pressure Pain Tolerance (PPTol) will be used to assess pain modulation in response to exercise across circadian phases.

    Unit: kg/cm²

    Measured: Baseline (0 minute before intervention) and immediately post-intervention (within 2 minutes) Measured in both high intensity functional training (HIFT) and supervised deep-breathing conditions during each morning and evening session

Secondary outcomes (7)
  1. Munich Chronotype Questionnaire (MCTQ)

    Chronotype will be assessed using the Munich Chronotype Questionnaire (MCTQ). Participants will be classified as morning or evening chronotypes to examine whether individual circadian preference moderates exercise-induced hypoalgesia.

    Measured: Baseline (before any intervention session)

  2. Pain Catastrophizing (PCS)

    Pain-related cognitions will be measured using the Pain Catastrophizing Scale (PCS) to control for potential psychological influences and understandings on pain perception. PCS is scored according to a 5-point Likert scale ranging from 0 = not at all to 4 = all the time with a maximum score of 52, with higher scores >30 indicating increased pain catastrophizing.

    Measured: Baseline (before any intervention session)

  3. Fear of Pain (FPQ-9)

    Fear of pain will be assessed using the Fear of Pain Questionnaire-9 (FPQ-9), as psychological fear responses may influence pain reporting. Fear of Pain Questionnaire-9 (FPQ-9) is scored by using a 5-point Likert scale with a score ranging from 9 to 45 with higher scores indicate greater fear of pain.

    Measured: Baseline (before any intervention session)

  4. Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI)

    The Brief Pittsburgh Sleep Quality Index (B-PSQI) will be used to assess participants' sleep patterns and their potential influence on pain modulation. Total score ranges between 0 and 15, where higher values suggest worse quality of sleep. Scores from 0 to 5 indicate good sleep quality and scores of ≥6 poor sleep quality.

    Measured: Baseline (before any intervention session)

  5. Depression Anxiety Stress Scales (DASS-21)

    Depression, Anxiety, and Stress Scale-21 (DASS-21) will be administered to capture psychological states that may influence experimental pain measures. Scores are presented as a total score (between 0 and 63) and a score for the three subscales (between 0 and 21). Higher scores indicate worse psychological distress.

    Measured: Baseline (before any intervention session)

  6. Rate of Perceived Exertion (RPE, Borg scale)

    Rate of Perceived Exertion (RPE, Borg scale) will be recorded during High intensity functional training (HIFT) to confirm intensity differences between interventions. A scale of 0-10 (1 being very light, and 10 being maximum effort) is used.

    Measured: At minute 0 (before warm-up), at minute 5 (after warm-up), every 1 minute during the high-intensity functional training (HIFT) protocol, and at minute 17 (end of session).

  7. Rate of Perceived Relaxation (RPR)

    Relaxation level during supervised deep breathing control session will be assessed using a 0-10 relaxation scale. The score range is 0 (no relaxation) to 10 (maximum relaxation) with higher scores indicate better relaxation.

    Measured: At minute 0 (baseline) and at minute 12 (immediately after the supervised deep-breathing session).

Timeline

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

  1. First posted18 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionApr 2026 (estimated)

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
Model description
Participants who completed the morning sessions will cross over to the evening sessions and vice versa in a randomized order with a washout period.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290465
Sponsor's protocol ID
E-10840098-202.3.02-1597
Status last verified
Dec 2025
First submitted
14 Nov 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Functional Training (HIFT) and Supervised Deep Breathing in people with Exercise Induced Hypoalgesia and Circadian Rhythm, run by Medipol University at 1 site in Turkey (Türkiye).

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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 Dec 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fatema Mohamed Soliman, PT, MSc (Cand.) (+90 537 736 20 79 ext. +20 15 0156870, pt.fatemasoliman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (PPT) (time frame: Baseline (0 minute before intervention) and immediately post-intervention (within 2 minutes) Measured in both high intensity functional training (HIFT) and supervised deep-breathing conditions during each morning and evening session). The study lists 2 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 18 Dec 2025.

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