The Effects of a Moderate Intensity Training Program Versus a High Intensity Training Program on Central Pain Processing

NCT06207422 | Terminated

• 1 other identifier: ONZ-2023-0425
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown that healthy individuals who take more steps per day and who spend more time on moderate- to vigorous-intensity activities exhibit better pain inhibition and less pain facilitation. Furthermore, exercise training (i.e., exercise performed over a number of sessions) can result in reduced pain sensitivity (increased pressure pain threshold). However, the optimal exercise prescription required to achieve pain sensitivity reduction is currently unclear. The next step is to determine experimentally whether increasing physical fitness will lead to positive effects on central pain processing (i.e., pain sensitivity, pain modulation, spinal nociception). The aim of this study is to examine the effects of two exercise programs on central pain processing in healthy sedentary individuals. In case of positive effects, this would provide a rationale for the future to investigate this in chronic pain patients with impaired pain modulation.

Conditions

Healthy

Keywords

moderate intensity training; high intensity training; pressure pain threshold; conditioned pain modulation; exercise induced hypoalgesia; nociceptive flexion reflex; quantitative sensory testing

Outcome Measures

Primary Outcomes (5)

• Pressure pain threshold

  Pressure algometry will be performed using a digital algometer to determine the pressure pain threshold bilaterally on the muscle belly of the extensor carpi radialis and the rectus femoris.

  Change from baseline (T1) at 1 week after intervention (T2)

• Conditioned pain modulation

  A conditioned pain modulation paradigm will be performed in which the measurement of the pressure pain threshold (= test stimulus) will be repeated on the dominant body side during (at minute two) and two minutes after immersion of the non-dominant hand in a warm water bath (= conditioning stimulus) of 45.5°C for six minutes.

  Change from baseline (T1) at 1 week after intervention (T2)

• Exercise-induced hypoalgesia

  To evaluate exercise-induced hypoalgesia, the pressure pain threshold measurements will be repeated before (bilaterally) and after (on the dominant body side) a submaximal exercise test (Aerobic Power Index test) performed on an electrically braked bicycle ergometer.

  Change from baseline (T1) at 1 week after intervention (T2)

• Nociceptive flexion reflex - threshold

  The nociceptive flexion reflex will be elicited by performing transcutaneous electrical nerve stimulation of the sural nerve of the dominant leg in its retromalleolar path using a bar electrode. The elicitation of the NFR will be evaluated by measuring the involuntary contraction of the ipsilateral biceps femoris, which will be recorded using electromyography.

  Change from baseline (T1) at 1 week after intervention (T2)

• Nociceptive flexion reflex - temporal summation

  Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times.

  Change from baseline (T1) at 1 week after intervention (T2)

Secondary Outcomes (11)

• Hospital anxiety and depression scale

  Baseline (T1)

• International physical activity questionnaire

  Change from baseline (T1) at 1 week after intervention (T2)

• Moderate physical activity

  Change from baseline (T1) at 1 week after intervention (T2)

• Vigorous physical activity

  Change from baseline (T1) at 1 week after intervention (T2)

• Sedentary behavior

  Change from baseline (T1) at 1 week after intervention (T2)

Study Arms (2)

Moderate intensity training program

EXPERIMENTAL

Other: Moderate intensity training program

High intensity training program

EXPERIMENTAL

Other: High intensity training program

Interventions

Moderate intensity training program OTHER

A 10-week intervention program performed at 60-70% of the heart rate reserve. Heart rate reserve will be calculated using the Karvonen formula (target heart rate = \[(predicted maximum heart rate (= 220 - age) - resting heart rate) x %intensity\] + resting heart rate). The intervention program will consist of three exercise sessions per week, of which one guided group session at Ghent University Hospital and two sessions to be carried out at home.

Moderate intensity training program

High intensity training program OTHER

A 10-week intervention program performed at ≥80% of the predicted maximum heart rate (target heart rate = predicted maximum heart rate (= 220 - age) x %intensity). The intervention program will consist of three exercise sessions per week, of which one guided group session at Ghent University Hospital and two sessions to be carried out at home.

High intensity training program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 55 years
• BMI between 20 and 25 kg/m²
• Dutch-speaking
• sedentary job and performing less than 3 hours of moderate physical activity per week

You may not qualify if:

• current pain complaints or other (medical and/or psychological) health problems
• history of serious pain complaints or (medical and/or psychological) health problems
• history of serious conditions (e.g. cancer, cardiovascular disease, epilepsy, diabetes, depression, etc.)
• being pregnant
• pregnant in the past 12 months
• currently breastfeeding

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (6)

• Belavy DL, Van Oosterwijck J, Clarkson M, Dhondt E, Mundell NL, Miller CT, Owen PJ. Pain sensitivity is reduced by exercise training: Evidence from a systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Jan;120:100-108. doi: 10.1016/j.neubiorev.2020.11.012. Epub 2020 Nov 27.

  PMID: 33253748 BACKGROUND

• Bernstein MS, Morabia A, Sloutskis D. Definition and prevalence of sedentarism in an urban population. Am J Public Health. 1999 Jun;89(6):862-7. doi: 10.2105/ajph.89.6.862.

  PMID: 10358676 BACKGROUND

• Dhondt E, Danneels L, Van Oosterwijck S, Palmans T, Rijckaert J, Van Oosterwijck J. The influence of physical activity on the nociceptive flexion reflex in healthy people. Eur J Pain. 2021 Apr;25(4):774-789. doi: 10.1002/ejp.1708. Epub 2020 Dec 27.

  PMID: 33290578 BACKGROUND

• Hakansson S, Jones MD, Ristov M, Marcos L, Clark T, Ram A, Morey R, Franklin A, McCarthy C, Carli LD, Ward R, Keech A. Intensity-dependent effects of aerobic training on pressure pain threshold in overweight men: A randomized trial. Eur J Pain. 2018 Nov;22(10):1813-1823. doi: 10.1002/ejp.1277. Epub 2018 Jul 11.

  PMID: 29956398 BACKGROUND

• Hermans L, Van Oosterwijck J, Goubert D, Goudman L, Crombez G, Calders P, Meeus M. Inventory of Personal Factors Influencing Conditioned Pain Modulation in Healthy People: A Systematic Literature Review. Pain Pract. 2016 Jul;16(6):758-69. doi: 10.1111/papr.12305. Epub 2015 May 26.

  PMID: 26011523 BACKGROUND

• Van Oosterwijck S, Meeus M, van Der Wekken J, Dhondt E, Billens A, Van Oosterwijck J. Physical Activity Is Predictive of Conditioned Pain Modulation in Healthy Individuals: A Cross-Sectional Study. J Pain. 2024 Nov;25(11):104639. doi: 10.1016/j.jpain.2024.104639. Epub 2024 Jul 18.

  PMID: 39029881 BACKGROUND

Study Officials

• Jessica Van Oosterwijck

  Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 17, 2024
• Study Start: November 27, 2023
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

BE (1)