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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Exercise | Experimental | The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week. |
|
| Moderate Dose Exercise | Experimental | The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week. |
|
| High Dose Exercise | Experimental | The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week. |
|
| Control | Sham Comparator | The Control group will perform quiet rest, three times per week for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking Exercise | Behavioral | Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes. |
|
| 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). |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Szucs, PhD | Duquesne University | Principal Investigator |
| Amy L Phelps, PhD | Duquesne University | Principal Investigator |
| Matthew C Kostek, PhD | Duquesne University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duquesne University | Pittsburgh | Pennsylvania | 15282 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31619738 | Result | Polaski AM, Phelps AL, Szucs KA, Ramsey AM, Kostek MC, Kolber BJ. The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants. Sci Rep. 2019 Oct 16;9(1):14842. doi: 10.1038/s41598-019-51247-0. |
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There is no plan to share. Raw data is available through the peer review publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Moderate Dose Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
Adverse events were collected during trial period only (1 week)
Adverse events will be reported to IRB (Institutional Review Board).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benedict Kolber | Duquesne University (now at University of Texas at Dallas) | 972-883-7225 | Benedict.kolber@utdallas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2016 | Mar 10, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2016 | Mar 10, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009043 | Motor Activity |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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Pseudo-randomized controlled trial
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| Control | Behavioral | The Control group will perform 30 minutes of quiet rest. |
|
| 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 |
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 |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | 100*Value at 24 hours/Value at Baseline | baseline and 24 hrs-post final intervention session |
|
|
|
| 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). | Posted | Mean | Standard Error | Percent | days 1, 3, & 5 at start and end of each exercise session |
|
|
|
| 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). | Posted | Mean | Standard Error | Percent | days 1, 3, & 5 at start and end of each exercise session |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Calf |
|
| calf |
|
| calf |
|
| calf |
|
| calf |
|
| calf |
|
| calf |
|
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| Day 5 |
|
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| Day 5 |
|