Exercise Dosing for Pain in Healthy Participants

Study Overview
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Brief Summary
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In this study investigators will examine the effect of dose related to exercise therapy for pain in healthy adult humans. An acute pain model will be employed to study the effect of exercise dose on pain. Acute pain models are currently used to study pain (both acute and chronic) in human samples as there is currently no chronic pain model.

Detailed Description
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This study is designed as a randomized controlled trial with repeated measures. The effect of exercise dose on pain: subjects will be randomly assigned to one of four exercise groups: 1.) no exercise (control); 2.) low dose exercise (3x/week); 3.) moderate dose exercise (5x/week). 4.) high dose exercise (10x/week).

Official Title
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The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Walking Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between age 18-40 Normal BMI (18.5-25.0) Heart Rate (HR) 60-100 bmp BP less than or equal to 140/90 Exclusion Criteria: Age <18 or >40 years Cardiac, respiratory, neurological or musculoskeletal disease Acute pain Chronic pain condition Diabetes BMI ≥ 25.1 or ≤ 18.4 Regular participation in high intensity athletic/sporting activities Sedentary Anxiety or depression disorders Tape allergy Currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pseudo-randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Exercise<br>The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week. | Behavioral: Walking Exercise<br>* Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.<br>|
| Experimental: Moderate Dose Exercise<br>The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week. | Behavioral: Walking Exercise<br>* Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.<br>|
| Experimental: High Dose Exercise<br>The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week. | Behavioral: Walking Exercise<br>* Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.<br>|
| Sham Comparator: Control<br>The Control group will perform quiet rest, three times per week for one week. | Behavioral: Control<br>* The Control group will perform 30 minutes of quiet rest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Effects on Mechanical Sensitivity Threshold | Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response. | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Constant Heat Pain Intensity | Subjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where 0 represents no pain and 10 represents the worst pain imaginable (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Constant Heat Pain Unpleasantness | Subjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where 0 represents not unpleasant and 10 represents the most unpleasant sensation imaginable (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Radiant Heat Sensitivity | Subjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their sensitivity threshold to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Radiant Heat Pain | Subjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their pain threshold to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Pressure Pain Threshold | Subjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at pain threshold). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Constant Pressure Pain Intensity | Subjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where 0 represents no pain and 10 represents the worst pain imaginable (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 
| Intervention Effects on Constant Pressure Pain Unpleasantness | Subjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where 0 represents not unpleasant and 10 represents the most unpleasant sensation imaginable (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). | baseline and 24 hrs-post final intervention session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate will be measured before and after each exercise session. Percent pre-exercise session in heart rate (bpm) from start to end of exercise session will be calculated (100*Value at end trial/Value at start of trial). | days 1, 3, & 5 at start and end of each exercise session | 
| Borg Rate of Perceived Exertion (RPE) | Subjects will indicate rate of perceived exertion before and after each exercise session. Percent of pre-exercise RPE from start to end of exercise session will be calculated (100* end of trial / start of trial). | days 1, 3, & 5 at start and end of each exercise session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Dose, Analgesia