Pain in Aging Former Athletes, Master's Athletes, and Nonathletes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorMarquette University

About this trial

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:

1. How do former athletes, master's athletes, and nonathletes experience pain? 2. How do different types of moderate-intensity exercise (strength versus aerobic exercise) influence pain in former athletes, master's athletes, and nonathletes?

Participants will complete 3 different testing sessions:

1. Baseline testing including assessments of strength, cardiorespiratory fitness, and pain; 2. Strength exercise: pain assessments will occur before and after moderate-intensity strength training exercise; 3. Aerobic exercise: pain assessments will occur before and after moderate-intensity aerobic exercise.

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 35 years through 65 years

Current master's athlete, former competitive athletes, or non-athlete control (see details below)

Ability to participate in exercise and exercise testing based on the Physical Activity Readiness Questionnaire (PAR-Q+)

Disqualifiers

Currently pregnant or planning to become pregnant during the study

Currently taking heart rate lowering medications (e.g., betablockers) that would impact exercise testing

Contraindications to ice such as Raynaud's, cryoglobulinemia, cold urticaria, and/or impaired circulation or sensation

Fibromyalgia and/or chronic regional pain syndrome (CRPS)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Moderate-Intensity Strength Exercise Intervention

    Other 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.

  • Moderate-Intensity Aerobic Exercise Intervention

    Other 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Former Competitive AthletesExperimental treatment 2 interventions
Group B: Master's AthletesActive comparator 2 interventions
Group C: Nonathlete ControlsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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
2

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
3

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)
4

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

Other outcomes

1

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)
2

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
3

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
4

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

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