Pain Perception and Exercise-Induced Hypoalgesia Across Circadian Rhythms

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое High-Intensity Functional Training (HIFT)
  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,
• Поведенческое Supervised Deep Breathing
  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-ex

Первичные конечные точки

• Pressure Pain Threshold (PPT) [Срок оценки: 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]
• Pressure Pain Tolerance (PPTol) [Срок оценки: 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]

Вторичные конечные точки (7)

• Munich Chronotype Questionnaire (MCTQ) [Срок оценки: Baseline (before any intervention session)]
• Pain Catastrophizing (PCS) [Срок оценки: Baseline (before any intervention session)]
• Fear of Pain (FPQ-9) [Срок оценки: Baseline (before any intervention session)]
• Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI) [Срок оценки: Baseline (before any intervention session)]
• Depression Anxiety Stress Scales (DASS-21) [Срок оценки: Baseline (before any intervention session)]
• Rate of Perceived Exertion (RPE, Borg scale) [Срок оценки: 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).]
• Rate of Perceived Relaxation (RPR) [Срок оценки: At minute 0 (baseline) and at minute 12 (immediately after the supervised deep-breathing session).]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT07290465 · E-10840098-202.3.02-1597

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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