HealthyChronicPA-PAINNCT06207422
The Effects of a Moderate Intensity Training Program Versus a High Intensity Training Program on Central Pain Processing
A study testing Moderate intensity training program and High intensity training program in people with Healthy, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Moderate intensity training program and High intensity training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Nov 2023to 23 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objectives:
Since research on the effects of chronic exercise interventions on pain modulation is scarce and since there is no optimal exercise prescription to reduce pain sensitivity, the effects of a moderate intensity training (MIT) program versus a high intensity training (HIT) program on central pain processing will be examined in healthy sedentary individuals.
Study population:
Thirty healthy sedentary adults between 18 and 55 years of age and with a body mass index (BMI) between 20 and 25 kg/cm² will be recruited. Sedentary is defined as "having a sedentary job and performing less than three hours of moderate physical activity per week". Moderate physical activity is defined as "an activity that requires at least three times the amount of passively expended energy". The sample size was calculated based on a similar previously conducted study.
Study Protocol:
The participants will be invited for a first contact moment (T0) at Ghent University Hospital or at the participant's homes. During T0, participants will be asked to sign an informed consent form. Furthermore, the procedure of the intervention will be explained and a general questionnaire on sociodemographic and health-related characteristics will be administered. Participants will then receive an ActiGraph accelerometer to take home and wear for seven consecutive days to monitor physical activity (i.e., number of steps, moderate and vigorous physical activity, and sedentary behavior).
After wearing the Actigraph accelerometer for seven consecutive days, participants will be invited for a first test moment (T1) at Ghent University Hospital. During T1, three questionnaires will be administered, namely a day survey (intake of medication, caffeine, alcohol and nicotine in the past 24 hours and performance of extreme physical exertion in the past 48 hours), the International Physical Activity Questionnaire (IPAQ) and the Hospital Anxiety and Depression Scale (HADS). Before the start of the experimental pain measurements, blood pressure will be measured with a blood pressure monitor and resting heart rate will be measured using a heart rate belt around the chest.
Next, central pain processing will be assessed:
- to evaluate pain sensitivity, pressure algometry will be performed using a digital algometer to determine the pressure pain threshold (PPT) bilaterally on the muscle belly of the extensor carpi radialis and the rectus femoris.
- to evaluate pain inhibition, a conditioned pain modulation (CPM) paradigm will be performed in which the measurement of the PPT (= test stimulus (TS)) 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 (CS)) of 45.5°C for six minutes.
- to evaluate exercise-induced hypoalgesia (EIH), the PPT 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. Cycling will start at a load of 25 W. Then the load will be increased by 25 W every minute until the submaximal level, defined as 75% of the predicted maximum heart rate (= 220 - age), is reached. Heart rate will be measured before, during, and after the test with a heart rate belt around the chest.
- to evaluate spinal nociception, transcutaneous electrical neurostimulation (TENS) of the n. suralis of the dominant leg will be performed using a bar electrode. The nociceptive flexion reflex (NFR) threshold will be determined, as well as the pain intensity during repetitive stimulation at the intensity of the NFR threshold to evaluate temporal summation of the NFR. The elicitation of the NFR will be evaluated by measuring the involuntary contraction of the ipsilateral biceps femoris, which will be recorded using electromyography (EMG).
After the experimental pain measurements, the test subjects will receive a Fitbit smartwatch to measure weekly step count during the 10-week exercise program.
After T1, the participants will be randomly assigned to one of two 10-week intervention programs, namely a MIT or a HIT program based on a 1:1 ratio.
Upon completion of the intervention, participants' physical activity will be monitored again for 7 consecutive days using an Actigraph accelerometer. After these 7 days, participants will be invited again for a second test moment (T2) at Ghent University Hospital. During T2, the day survey and the IPAQ will be administered again, blood pressure will be measured and the pain measurements will be repeated.
- Conditions
- Healthy
- Being tested
- Moderate intensity training program, High intensity training program
- Keywords
- moderate intensity training, high intensity training, pressure pain threshold, conditioned pain modulation, exercise induced hypoalgesia, nociceptive flexion reflex, quantitative sensory testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity training programOther
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.
High intensity training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity training program | Experimental | Not described Receives: Other: Moderate intensity training program |
| High intensity training program | Experimental | Not described Receives: Other: High intensity training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Secondary outcomes (11)
Hospital anxiety and depression scale
Self-report measure assessing anxiety and depression
Measured: Baseline (T1)
International physical activity questionnaire
Self-report measure assessing physical activity during the previous 7 days
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Moderate physical activity
Moderate physical activity will be measured with an ActiGraph accelerometer during 7 consecutive days.
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Vigorous physical activity
Vigorous physical activity will be measured with an ActiGraph accelerometer during 7 consecutive days.
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Sedentary behavior
Sedentary behavior will be measured with an ActiGraph accelerometer during 7 consecutive days.
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Step count
Step count will be measured with an ActiGraph accelerometer during 7 consecutive days.
Measured: Change from baseline (T1) at 1 week after intervention (T2)
Step count
Step count will be measured with a FitBit charge 4 during the 10-week intervention program
Measured: During 10-week intervention program
Resting heart rate
Resting heart rate will be measured for 10 minutes using a heart rate belt around the chest.
Measured: Baseline (T1)
Blood pressure
Systolic and diastolic blood pressure will be measured with a blood pressure monitor.
Measured: Baseline (T1)
Blood pressure
Systolic and diastolic blood pressure will be measured with a blood pressure monitor.
Measured: 1 week after intervention
Sociodemographic and health-related characteristics
A general questionnaire assessing sociodemographic and health-related characteristics
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start27 Nov 2023
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
Why it stopped: The study was terminated prematurely due to difficulties in participant recruitment. We reframed the project as a pilot feasibility study to better assess recruitment processes and inform the design of a future full-scale trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Principal investigator, Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207422
- Sponsor's protocol ID
- ONZ-2023-0425
- Acronym
- ChronicPA-PAIN
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33253748Bernstein 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.
PubMed 10358676Dhondt 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.
PubMed 33290578Hakansson 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.
PubMed 29956398Hermans 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.
PubMed 26011523Van 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.
PubMed 39029881Billens A, Hamelink T, Meeus M, Van Oosterwijck J. The influence of a moderate versus high intensity training program on central pain processing: a pilot feasibility study. Pain Manag. 2026 May;16(5):445-459. doi: 10.1080/17581869.2026.2626256. Epub 2026 Feb 6.
PubMed 41649235
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Moderate Intensity Training Program Versus a High Intensity Training Program on Central Pain Processing
- ClinicalTrials.gov ID
- NCT06207422
- Acronym / sponsor ID
- ChronicPA-PAIN / ONZ-2023-0425
- Conditions
- Healthy
- Keywords
- moderate intensity training, high intensity training, pressure pain threshold, conditioned pain modulation, exercise induced hypoalgesia, nociceptive flexion reflex, quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to difficulties in participant recruitment. We reframed the project as a pilot feasibility study to better assess recruitment processes and inform the design of a future full-scale trial.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Since research on the effects of chronic exercise interventions on pain modulation is scarce and since there is no optimal exercise prescription to reduce pain sensitivity, the effects of a moderate intensity training (MIT) program versus a high intensity training (HIT) program on central pain processing will be examined in healthy sedentary individuals.
Study population:
Thirty healthy sedentary adults between 18 and 55 years of age and with a body mass index (BMI) between 20 and 25 kg/cm² will be recruited. Sedentary is defined as "having a sedentary job and performing less than three hours of moderate physical activity per week". Moderate physical activity is defined as "an activity that requires at least three times the amount of passively expended energy". The sample size was calculated based on a similar previously conducted study.
Study Protocol:
The participants will be invited for a first contact moment (T0) at Ghent University Hospital or at the participant's homes. During T0, participants will be asked to sign an informed consent form. Furthermore, the procedure of the intervention will be explained and a general questionnaire on sociodemographic and health-related characteristics will be administered. Participants will then receive an ActiGraph accelerometer to take home and wear for seven consecutive days to monitor physical activity (i.e., number of steps, moderate and vigorous physical activity, and sedentary behavior).
After wearing the Actigraph accelerometer for seven consecutive days, participants will be invited for a first test moment (T1) at Ghent University Hospital. During T1, three questionnaires will be administered, namely a day survey (intake of medication, caffeine, alcohol and nicotine in the past 24 hours and performance of extreme physical exertion in the past 48 hours), the International Physical Activity Questionnaire (IPAQ) and the Hospital Anxiety and Depression Scale (HADS). Before the start of the experimental pain measurements, blood pressure will be measured with a blood pressure monitor and resting heart rate will be measured using a heart rate belt around the chest.
Next, central pain processing will be assessed:
- to evaluate pain sensitivity, pressure algometry will be performed using a digital algometer to determine the pressure pain threshold (PPT) bilaterally on the muscle belly of the extensor carpi radialis and the rectus femoris.
- to evaluate pain inhibition, a conditioned pain modulation (CPM) paradigm will be performed in which the measurement of the PPT (= test stimulus (TS)) 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 (CS)) of 45.5°C for six minutes.
- to evaluate exercise-induced hypoalgesia (EIH), the PPT 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. Cycling will start at a load of 25 W. Then the load will be increased by 25 W every minute until the submaximal level, defined as 75% of the predicted maximum heart rate (= 220 - age), is reached. Heart rate will be measured before, during, and after the test with a heart rate belt around the chest.
- to evaluate spinal nociception, transcutaneous electrical neurostimulation (TENS) of the n. suralis of the dominant leg will be performed using a bar electrode. The nociceptive flexion reflex (NFR) threshold will be determined, as well as the pain intensity during repetitive stimulation at the intensity of the NFR threshold to evaluate temporal summation of the NFR. The elicitation of the NFR will be evaluated by measuring the involuntary contraction of the ipsilateral biceps femoris, which will be recorded using electromyography (EMG).
After the experimental pain measurements, the test subjects will receive a Fitbit smartwatch to measure weekly step count during the 10-week exercise program.
After T1, the participants will be randomly assigned to one of two 10-week intervention programs, namely a MIT or a HIT program based on a 1:1 ratio.
Upon completion of the intervention, participants' physical activity will be monitored again for 7 consecutive days using an Actigraph accelerometer. After these 7 days, participants will be invited again for a second test moment (T2) at Ghent University Hospital. During T2, the day survey and the IPAQ will be administered again, blood pressure will be measured and the pain measurements will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity training program | Experimental | Other: Moderate intensity training program |
| High intensity training program | Experimental | Other: High intensity training program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity training programA 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. | Other | Moderate intensity training program |
| High intensity training programA 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. | Other | High intensity training program |
Primary outcome
Pressure pain threshold
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
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.
Conditioned pain modulation
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
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.
Exercise-induced hypoalgesia
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
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.
Nociceptive flexion reflex - threshold
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
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.
Nociceptive flexion reflex - temporal summation
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
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.
11 secondary outcomes
Hospital anxiety and depression scale
Time frame: Baseline (T1)
International physical activity questionnaire
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
Moderate physical activity
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
Vigorous physical activity
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
Sedentary behavior
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
Step count
Time frame: Change from baseline (T1) at 1 week after intervention (T2)
Step count
Time frame: During 10-week intervention program
Resting heart rate
Time frame: Baseline (T1)
Blood pressure
Time frame: Baseline (T1)
Blood pressure
Time frame: 1 week after intervention
Sociodemographic and health-related characteristics
Time frame: Baseline (T0)
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to difficulties in participant recruitment. We reframed the project as a pilot feasibility study to better assess recruitment processes and inform the design of a future full-scale trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 33253748Belavy 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.
- Background: PubMed 10358676Bernstein 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.
- Background: PubMed 33290578Dhondt 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.
- Background: PubMed 29956398Hakansson 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.
- Background: PubMed 26011523Hermans 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.
- Background: PubMed 39029881Van 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.
- Derived from this study: PubMed 41649235Billens A, Hamelink T, Meeus M, Van Oosterwijck J. The influence of a moderate versus high intensity training program on central pain processing: a pilot feasibility study. Pain Manag. 2026 May;16(5):445-459. doi: 10.1080/17581869.2026.2626256. Epub 2026 Feb 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Van Oosterwijck principal investigator
Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity training program and High intensity training program in people with Healthy, run by University Ghent at 1 site in Belgium.
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 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: stopped early, as of the sponsor's last update on 8 Sep 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 Belgium. 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 was stopped early (reason given: The study was terminated prematurely due to difficulties in participant recruitment. We reframed the project as a pilot feasibility study to better assess recruitment processes and inform the design of a future full-scale trial.). Results are not available in the source record.
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?
Pressure pain threshold (time frame: Change from baseline (T1) at 1 week after intervention (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207422, which also lists 7 linked publications.
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 8 Sep 2025.