Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207422
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-18
Brief Title:
The Effects of a Moderate Intensity Training Program Versus a High Intensity Training Program on Central Pain Processing
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
The Effects of a Moderate Intensity Training Program Versus a High Intensity Training Program on Central Pain Processing
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChronicPA-PAIN
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 ie 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 ie 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 kgcm² 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 participants 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 ie 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
1 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
2 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 455C for six minutes
3 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
4 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 11 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
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 kgcm² 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 participants 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 ie 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
1 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
2 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 455C for six minutes
3 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
4 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None