Skip to content

Exercise Dosing for Pain in Healthy Participants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03642938
Enrollment
41
Registered
2018-08-22
Start date
2015-02-11
Completion date
2017-06-06
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Exercise, Dose, Analgesia

Brief summary

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

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).

Interventions

BEHAVIORALControl

The Control group will perform 30 minutes of quiet rest.

BEHAVIORALWalking Exercise

Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Duquesne University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pseudo-randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Between age 18-40 2. Normal BMI (18.5-25.0) 3. Heart Rate (HR) 60-100 bmp 4. BP less than or equal to 140/90

Exclusion criteria

1. Age \<18 or \>40 years 2. Cardiac, respiratory, neurological or musculoskeletal disease 3. Acute pain 4. Chronic pain condition 5. Diabetes 6. BMI ≥ 25.1 or ≤ 18.4 7. Regular participation in high intensity athletic/sporting activities 8. Sedentary 9. Anxiety or depression disorders 10. Tape allergy 11. Currently pregnant

Design outcomes

Primary

MeasureTime frameDescription
Intervention Effects on Constant Pressure Pain Unpleasantnessbaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Pressure Pain Thresholdbaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Constant Pressure Pain Intensitybaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Mechanical Sensitivity Thresholdbaseline and 24 hrs-post final intervention sessionSubjects' 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.
Intervention Effects on Constant Heat Pain Intensitybaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Constant Heat Pain Unpleasantnessbaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Radiant Heat Sensitivitybaseline and 24 hrs-post final intervention sessionSubjects' 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).
Intervention Effects on Radiant Heat Painbaseline and 24 hrs-post final intervention sessionSubjects' 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).

Secondary

MeasureTime frameDescription
Borg Rate of Perceived Exertion (RPE)days 1, 3, & 5 at start and end of each exercise sessionSubjects 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).
Heart Ratedays 1, 3, & 5 at start and end of each exercise sessionHeart 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Low Dose Exercise
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week. Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
10
Moderate Dose Exercise
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week. Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
10
High Dose Exercise
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week. Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
10
Control
The Control group will perform quiet rest, three times per week for one week. Control: The Control group will perform 30 minutes of quiet rest.
10
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject0001

Baseline characteristics

CharacteristicModerate Dose ExerciseHigh Dose ExerciseControlLow Dose ExerciseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants10 Participants10 Participants40 Participants
Age, Continuous22.3 years
STANDARD_DEVIATION 3
20.6 years
STANDARD_DEVIATION 1.3
22.7 years
STANDARD_DEVIATION 3.7
20.7 years
STANDARD_DEVIATION 0.7
21.58 years
STANDARD_DEVIATION 2.2
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
10 participants10 participants10 participants10 participants40 participants
Sex: Female, Male
Female
10 Participants10 Participants10 Participants10 Participants40 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Constant Heat Pain IntensityForearm88.79 100*Value at 24 hours/Value at BaselineStandard Error 4.819
Low Dose ExerciseIntervention Effects on Constant Heat Pain IntensityCalf59.46 100*Value at 24 hours/Value at BaselineStandard Error 9.12
Moderate Dose ExerciseIntervention Effects on Constant Heat Pain IntensityCalf114.3 100*Value at 24 hours/Value at BaselineStandard Error 34.57
Moderate Dose ExerciseIntervention Effects on Constant Heat Pain IntensityForearm80.03 100*Value at 24 hours/Value at BaselineStandard Error 21.37
High Dose ExerciseIntervention Effects on Constant Heat Pain IntensityForearm80.16 100*Value at 24 hours/Value at BaselineStandard Error 14.24
High Dose ExerciseIntervention Effects on Constant Heat Pain IntensityCalf79.4 100*Value at 24 hours/Value at BaselineStandard Error 22.68
ControlIntervention Effects on Constant Heat Pain IntensityForearm110.4 100*Value at 24 hours/Value at BaselineStandard Error 55.2
ControlIntervention Effects on Constant Heat Pain IntensityCalf136.3 100*Value at 24 hours/Value at BaselineStandard Error 31.55
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnessforearm110.1 100*Value at 24 hours/Value at BaselineStandard Error 20.33
Low Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnesscalf65.94 100*Value at 24 hours/Value at BaselineStandard Error 9.63
Moderate Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnesscalf137.5 100*Value at 24 hours/Value at BaselineStandard Error 33.49
Moderate Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnessforearm130.7 100*Value at 24 hours/Value at BaselineStandard Error 48.24
High Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnessforearm110.6 100*Value at 24 hours/Value at BaselineStandard Error 35.89
High Dose ExerciseIntervention Effects on Constant Heat Pain Unpleasantnesscalf83.20 100*Value at 24 hours/Value at BaselineStandard Error 24.27
ControlIntervention Effects on Constant Heat Pain Unpleasantnessforearm79.63 100*Value at 24 hours/Value at BaselineStandard Error 39.68
ControlIntervention Effects on Constant Heat Pain Unpleasantnesscalf118.1 100*Value at 24 hours/Value at BaselineStandard Error 39.5
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Constant Pressure Pain Intensityforearm93.3 100*Value at 24 hours/Value at BaselineStandard Error 17.15
Low Dose ExerciseIntervention Effects on Constant Pressure Pain Intensitycalf89.6 100*Value at 24 hours/Value at BaselineStandard Error 10.88
Moderate Dose ExerciseIntervention Effects on Constant Pressure Pain Intensitycalf85.37 100*Value at 24 hours/Value at BaselineStandard Error 33.67
Moderate Dose ExerciseIntervention Effects on Constant Pressure Pain Intensityforearm49.6 100*Value at 24 hours/Value at BaselineStandard Error 6.87
High Dose ExerciseIntervention Effects on Constant Pressure Pain Intensityforearm67.26 100*Value at 24 hours/Value at BaselineStandard Error 25.76
High Dose ExerciseIntervention Effects on Constant Pressure Pain Intensitycalf74.30 100*Value at 24 hours/Value at BaselineStandard Error 16.17
ControlIntervention Effects on Constant Pressure Pain Intensityforearm157.6 100*Value at 24 hours/Value at BaselineStandard Error 20.83
ControlIntervention Effects on Constant Pressure Pain Intensitycalf84.14 100*Value at 24 hours/Value at BaselineStandard Error 11.23
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnessforearm92.61 100*Value at 24 hours/Value at BaselineStandard Error 17.34
Low Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnesscalf80.51 100*Value at 24 hours/Value at BaselineStandard Error 9.95
Moderate Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnesscalf76.56 100*Value at 24 hours/Value at BaselineStandard Error 27.48
Moderate Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnessforearm46.62 100*Value at 24 hours/Value at BaselineStandard Error 9.4
High Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnessforearm46.58 100*Value at 24 hours/Value at BaselineStandard Error 14.6
High Dose ExerciseIntervention Effects on Constant Pressure Pain Unpleasantnesscalf95.01 100*Value at 24 hours/Value at BaselineStandard Error 36.24
ControlIntervention Effects on Constant Pressure Pain Unpleasantnessforearm127.9 100*Value at 24 hours/Value at BaselineStandard Error 19.25
ControlIntervention Effects on Constant Pressure Pain Unpleasantnesscalf114.7 100*Value at 24 hours/Value at BaselineStandard Error 35.59
Primary

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.

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdForearm Data125.6 100*Value at 24 hours/Value at BaselineStandard Error 38
Low Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdCalf Data299 100*Value at 24 hours/Value at BaselineStandard Error 138.9
Moderate Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdCalf Data396.7 100*Value at 24 hours/Value at BaselineStandard Error 138.1
Moderate Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdForearm Data93.56 100*Value at 24 hours/Value at BaselineStandard Error 36.03
High Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdForearm Data63.04 100*Value at 24 hours/Value at BaselineStandard Error 15.08
High Dose ExerciseIntervention Effects on Mechanical Sensitivity ThresholdCalf Data202.4 100*Value at 24 hours/Value at BaselineStandard Error 65.09
ControlIntervention Effects on Mechanical Sensitivity ThresholdForearm Data70.27 100*Value at 24 hours/Value at BaselineStandard Error 23.15
ControlIntervention Effects on Mechanical Sensitivity ThresholdCalf Data287 100*Value at 24 hours/Value at BaselineStandard Error 138.9
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Pressure Pain Thresholdforearm135.5 100*Value at 24 hours/Value at BaselineStandard Error 9.78
Low Dose ExerciseIntervention Effects on Pressure Pain Thresholdcalf122.6 100*Value at 24 hours/Value at BaselineStandard Error 8.66
Moderate Dose ExerciseIntervention Effects on Pressure Pain Thresholdcalf134.7 100*Value at 24 hours/Value at BaselineStandard Error 10.02
Moderate Dose ExerciseIntervention Effects on Pressure Pain Thresholdforearm143.3 100*Value at 24 hours/Value at BaselineStandard Error 14.01
High Dose ExerciseIntervention Effects on Pressure Pain Thresholdforearm150.1 100*Value at 24 hours/Value at BaselineStandard Error 21.57
High Dose ExerciseIntervention Effects on Pressure Pain Thresholdcalf130.8 100*Value at 24 hours/Value at BaselineStandard Error 15.54
ControlIntervention Effects on Pressure Pain Thresholdforearm111 100*Value at 24 hours/Value at BaselineStandard Error 9.01
ControlIntervention Effects on Pressure Pain Thresholdcalf124.5 100*Value at 24 hours/Value at BaselineStandard Error 12.65
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Radiant Heat Painforearm98.65 100*Value at 24 hours/Value at BaselineStandard Error 1.81
Low Dose ExerciseIntervention Effects on Radiant Heat Paincalf100.6 100*Value at 24 hours/Value at BaselineStandard Error 2.4
Moderate Dose ExerciseIntervention Effects on Radiant Heat Paincalf99.59 100*Value at 24 hours/Value at BaselineStandard Error 1.7
Moderate Dose ExerciseIntervention Effects on Radiant Heat Painforearm96.83 100*Value at 24 hours/Value at BaselineStandard Error 3.14
High Dose ExerciseIntervention Effects on Radiant Heat Painforearm97.10 100*Value at 24 hours/Value at BaselineStandard Error 2.42
High Dose ExerciseIntervention Effects on Radiant Heat Paincalf104.5 100*Value at 24 hours/Value at BaselineStandard Error 2.66
ControlIntervention Effects on Radiant Heat Painforearm99.2 100*Value at 24 hours/Value at BaselineStandard Error 2.6
ControlIntervention Effects on Radiant Heat Paincalf101.9 100*Value at 24 hours/Value at BaselineStandard Error 1.999
Primary

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).

Time frame: baseline and 24 hrs-post final intervention session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseIntervention Effects on Radiant Heat Sensitivityforearm99.08 100*Value at 24 hours/Value at BaselineStandard Error 1.4
Low Dose ExerciseIntervention Effects on Radiant Heat Sensitivitycalf100.1 100*Value at 24 hours/Value at BaselineStandard Error 2.68
Moderate Dose ExerciseIntervention Effects on Radiant Heat Sensitivitycalf101.5 100*Value at 24 hours/Value at BaselineStandard Error 1.51
Moderate Dose ExerciseIntervention Effects on Radiant Heat Sensitivityforearm101.2 100*Value at 24 hours/Value at BaselineStandard Error 2.4
High Dose ExerciseIntervention Effects on Radiant Heat Sensitivityforearm99.8 100*Value at 24 hours/Value at BaselineStandard Error 1.46
High Dose ExerciseIntervention Effects on Radiant Heat Sensitivitycalf102.8 100*Value at 24 hours/Value at BaselineStandard Error 3.1
ControlIntervention Effects on Radiant Heat Sensitivityforearm100.8 100*Value at 24 hours/Value at BaselineStandard Error 1.4
ControlIntervention Effects on Radiant Heat Sensitivitycalf102 100*Value at 24 hours/Value at BaselineStandard Error 1.5
Secondary

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).

Time frame: days 1, 3, & 5 at start and end of each exercise session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 3147.2 PercentStandard Error 6.8
Low Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 1144 PercentStandard Error 5.4
Low Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 5154.6 PercentStandard Error 9.12
Moderate Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 3156.3 PercentStandard Error 7.12
Moderate Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 1159.4 PercentStandard Error 8.1
Moderate Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 5155.71 PercentStandard Error 7.11
High Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 1152.45 PercentStandard Error 12.17
High Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 5157.98 PercentStandard Error 7.98
High Dose ExerciseBorg Rate of Perceived Exertion (RPE)Day 3161.3 PercentStandard Error 6.16
Secondary

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).

Time frame: days 1, 3, & 5 at start and end of each exercise session

ArmMeasureGroupValue (MEAN)Dispersion
Low Dose ExerciseHeart RateDay 3121.443 PercentStandard Error 3.218
Low Dose ExerciseHeart RateDay 1124.12 PercentStandard Error 4.2
Low Dose ExerciseHeart RateDay 5113.440 PercentStandard Error 5.272
Moderate Dose ExerciseHeart RateDay 3118.8 PercentStandard Error 5.7
Moderate Dose ExerciseHeart RateDay 1115.87 PercentStandard Error 7.15
Moderate Dose ExerciseHeart RateDay 5112.226 PercentStandard Error 4.632
High Dose ExerciseHeart RateDay 1112.349 PercentStandard Error 1.747
High Dose ExerciseHeart RateDay 5109.221 PercentStandard Error 3.435
High Dose ExerciseHeart RateDay 3110.16 PercentStandard Error 2.122

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026