An interventional study of Moderate-Intensity Strength Exercise Intervention and Moderate-Intensity Aerobic Exercise Intervention in Pain, Pain Management and Athlete, sponsored by Marquette University. Recruiting at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Marquette University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine how male and female former athletes experience pain and respond to moderate-intensity exercise (strength versus aerobic) compared with both current master's athletes and nonathletes.
The main questions this study aims to address are:
Participants will complete 3 different testing sessions:
There will be a washout period of approximately one week or greater between each of the three different testing sessions. The order of conditions (strength versus aerobic exercise) will be randomized (crossover randomized trial design).
Two major health challenges facing midlife adults in our society are chronic pain and insufficient physical activity (PA). Chronic pain is highly prevalent among females and those who previously engaged in substantial vigorous PA, such as former competitive athletes. Exercise (i.e., a specific planned subtype of PA) is one of the best interventions for optimizing health, maintaining function, and preserving cardiorespiratory fitness - yet ironically often not continued among midlife adults who were highly physically active as youth and young adults in competitive sports. While PA and other lifestyle behaviors (e.g., sleep) likely influence pain processing and response to exercise, the mechanisms underlying pain in males and females with distinct PA trajectories are unknown. Pain is a common and critical barrier to regular exercise. Yet exercise has paradoxical effects on pain, generally increasing pain during exercise and providing pain relief after, i.e., exercise-induced hypoalgesia. While higher exercise intensities may lead to greater exercise-induced hypoalgesia, the greater pain and discomfort experienced during high-intensity exercise may prevent uptake, making moderate-intensity exercise a promising solution balancing physiological benefits and exercise-induced hypoalgesia. The investigators' long-term objective is to alleviate pain, increase PA, and improve health in midlife and aging adults. This randomized crossover clinical trial will determine how markedly different PA trajectories and sex influence pain, lifestyle behaviors, and the pain response to exercise (exercise-induced hypoalgesia). Given that pain is affected by PA and sports history, this proposal will examine pain processing in midlife males and females with distinct PA trajectories evenly split across 3 unique groups: 1) former athletes no longer participating in sports; 2) master's athletes; and 3) nonathletes.
In order to compare pain perceptions and processing in former athletes, master's athletes, and nonathletes, quantitative sensory testing and validated questionnaires will be used. Lifestyle behaviors (PA and sleep) will be assessed using wearable devices. Moderate-intensity strength and aerobic exercise interventions will be included to determine how these influence the pain perceptions of former athletes, current master's athletes and nonathletes. Full participation will involve completing three in-person sessions including baseline assessment session and two intervention sessions (i.e., follow-up 1 and follow-up 2 at approximately 1 week intervals) at Marquette University as well as wearing a small physical activity monitor for 2 weeks following baseline session and an OURA ring for the duration of the study.
Aim 1: Determine the impact of physical activity history (group) and sex on (1a) pain processing and (1b) lifestyle behaviors in midlife adults (former athletes, master's athletes, and nonathletes).
Aim 2: Quantify the effect of physical activity history (group) and sex on the change in pain response to moderate-intensity exercise and explore differences in pain response to exercise modality (i.e., strength versus aerobic).
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 90 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria (General):
Participants will be enrolled into one of the following three mutually exclusive groups according to the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Former competitive athletes will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.
Other: Moderate-Intensity Strength Exercise Intervention · Other: Moderate-Intensity Aerobic Exercise Intervention
Master's Athletes will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.
Other: Moderate-Intensity Strength Exercise Intervention · Other: Moderate-Intensity Aerobic Exercise Intervention
Nonathlete Controls will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.
Other: Moderate-Intensity Strength Exercise Intervention · Other: Moderate-Intensity Aerobic Exercise Intervention
Participants will perform 10 isometric knee extension repetitions unilaterally on both sides separately for 10 seconds with each repetition at 50% of their maximal volitional contraction (MVC) on an electromechanical dynamometer. Participants will be provided 50 seconds rest in between repetitions. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. If there is a more affected limb with regards to pain, the less affected limb will be exercised first. If there is not a more affected limb, side will be randomized. A warm up will be performed prior to the intervention.
Participants will complete aerobic exercise at 40-59% of their heart rate reserve (HRR) through the mode of incline walking on a treadmill for 30 minutes with a 2 -minute warm up and 2-minute cool down with a target intensity of \~50% HRR. Adjustments will be made to the incline and speed throughout the intervention as needed to maintain 40-59% HRR range. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. Heart rate will be measured throughout the walking intervention to ensure the participant is within the targeted range for moderate intensity; pre- and post-aerobic intervention heart rate and blood pressure will be taken.
Pain Tolerance
The maximum stimulus intensity that the participant can tolerate will be measured by placing a thermode (Q-Sense, Medoc) on the ventral forearm. Three trials will be completed with the baseline temperature set at 35°C that increases at a rate of 1°/s with a maximum temperature of 50°C. Participants will be asked to press a timing device when they can no longer tolerate the temperature (i.e., pain tolerance), and this temperature will be recorded as the maximum stimulus intensity.
Time frame: Baseline (Aim 1a)
Pressure Pain Threshold (PPT)
Pressure Pain Thresholds (PPTs) will be used to measure group differences in pain sensitivity at baseline and the hypoalgesic response (increase in PPTs) during the exercise sessions with a pressure algometer (Algomed, Medoc) at the exercising limb, contralateral limb, and systemically at the right upper trapezius muscle. Two trials separated by a 10-second interval will be performed at each site with a 1cm\^2 rubber tip at a rate of 50 kPA/sec. Participants will be instructed to press a timing device when the pressure first changes to pain (i.e., pain threshold). Practice trials with be performed on the fourth digit fingernail bed prior to formal assessment at quad/trap and order will be randomized. The change scores from pre- to post-strength exercise and from pre- to post-aerobic exercise will be used as the primary outcome in Aim 2.
Time frame: Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline) (Aim 2)
Physical Activity - Step Counts
Physical activity (PA) will be monitored continuously using an activPAL activity monitor. Step counts will be recorded as the average number of steps taken per day.
Time frame: Remote monitoring for 2 weeks during the study (Aim 1b)
Sedentary Behavior
Total sedentary behavior will be assessed using an activPAL activity monitor and recorded as the average daily amount of time in wakeful sedentary behavior (hours:minutes).
Time frame: Remote monitoring for 2 weeks during the study (Aim 1b)
Pain Intensity (pain perception)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-SF v.1.0 3a will be collected at baseline to capture average pain and worst pain intensity over the past 7 days and right now. The survey has 3 questions where respondents rates pain from no pain (1) to very severe pain (5). The total raw score ranges from 3 to 15 with higher scores indicating more severe pain.
Time frame: Baseline
Michigan Body Map for Pain (pain perception)
Pain distribution or location at rest and with movement will be assessed using the Michigan Body Map for Pain (validated questionnaire).
Time frame: Baseline
Temporal Summation of Pain (TSP)
Temporal summation of pain (TSP) is an increase in pain with a repetitive or constant-intensity, noxious stimulus and represents central pain facilitation. A custom-made pressure pain device, used frequently in the assessment of exercise-induced hypoalgesia, will assess TSP and consists of an 8 x 1.5-mm Lucite edge (Romus Inc., Milwaukee, WI) placed on the mid portion of the middle phalanx of the right index finger for 2 min. A 10-N force (equivalent to a 1-kg mass) will be applied to the Lucite edge, and participants will be asked to press a timing device when the pressure first changes to pain (i.e., pain threshold) and to rate the intensity of pain on a 0-10 numerical pain rating scale every 20-s throughout the test. The increase in the pain intensity during the 2-minute test represents TSP.
Time frame: Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Condition Pain Modulation (CPM)
Condition pain modulation (CPM) is the concept that pain inhibits pain and will be used to indirectly measure the efficiency of descending inhibitory pathways. For the CPM protocol, PPTs (test stimulus) will be measured using a pressure algometer (AlgoMed, Medoc) as described above at the quadriceps and upper trapezius muscles with and without the participant's foot submerged in an ice water bath (conditioning stimulus). An increase in PPTs during the conditioning stimulus represents the pain inhibits pain phenomenon, whereas no change or decrease in PPTs indicates low CPM efficiency.
Time frame: Baseline
Numeric Pain Rating Scale
The numeric pain rating scale (0-10) will be used to assess pain before, during, and after the strength and aerobic exercise interventions.
Time frame: Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline) and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Prolonged Bouts of Sedentary Behavior
Prolonged (\>1 hours) bouts of sedentary behavior will be assessed using an activPAL activity monitor.
Time frame: Remote monitoring for 2 weeks during the study (Aim 1b)
Sleep Duration
Sleep duration will be monitored remotely throughout the study using an Oura Ring. Sleep duration will be measured in time (hours:minutes) with greater values indicating longer sleep.
Time frame: Remote monitoring throughout the study (i.e., about 2-3 weeks)
Rating of Perceived Exertion
Rating of Perceived Exertion (RPE) will be assessed before, during, and after the strength and aerobic exercise interventions. The RPE scale ranges from 6 (no exertion at all) to 20 (maximal exertion) with high values indicating greater exertion.
Time frame: Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Knee Extension Strength
Participants will complete standardized isometric strength testing on an electromechanical dynamometer using our established protocol. Following submaximal warm-up efforts, participants will complete 5 maximal effort (i.e., 100%) isometric knee extensions (i.e., maximal volitional contractions \[MVCs\]) with rest breaks (\~1 minute) in between. The order of limbs will be randomized unless the participant has any knee or lower extremity pain prior to testing in which case the less involved limb will be tested first. The peak value from the MVC for each limb will be used to determine the target intensity of the moderate-intensity strength exercise intervention.
Time frame: Baseline
Cardiorespiratory Fitness Testing
Participants will perform the submaximal aerobic 3-minute YMCA Step Test using a 12-inch step at a stepping rate of 24 steps/min set via a metronome set to 96 beats/min for each foot movement. Following 3 minutes of stepping, the participant immediately stops, sits down, and remains still. The total one-minute post-exercise heart rate is the participant's score.
Time frame: Baseline
Injury and Surgical History
A detailed injury and surgical history will be captured by a licensed physical therapist or other trained study personnel using an injury and surgical history questionnaire.
Time frame: Baseline
Sleep Latency
Sleep latency will be monitored remotely throughout the study using an Oura Ring. Sleep latency is the time (in minutes) it takes to fall asleep.
Time frame: Remote monitoring throughout the study (i.e., about 2-3 weeks)
Physical Activity - Metabolic Equivalents of Task (METs)
Physical activity (PA) will be monitored continuously using an activPAL activity monitor. Metabolic equivalents of task, an indicator of overall activity level, will be recorded.
Time frame: Remote monitoring for 2 weeks during the study
Sleep Efficiency
Sleep efficiency will be monitored remotely throughout the study using an Oura Ring. Sleep efficiency is the percentage of time in bed spent asleep (0-100%). Higher values indicate greater sleep efficiency, whereas lower values are indicative of restlessness.
Time frame: Remote monitoring throughout the study (i.e., about 2-3 weeks)
Plan to share: Yes — Data will be shared in accordance with policies of the funder should this study receive extramural funding.
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