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We will investigate the effects of the length of education on exercise-induced hypoalgesia (EIH). Two previous studies have shown that positive education about the effects of exercise and the phenomena of EIH produce enhancements to EIH response (having decreased reports of pain with exercise). These previous studies used different amounts of education time, this study will compare directly if the length of education time varies the effects on EIH.
The use of fliers will be posted on USD campus explaining study and the need for volunteers. Potential volunteers will contact study personal listed on the flier to set up potential time for study enrollment. When the prospective participant arrives, they will be provided a hard copy of informed consent and study personnel will be available to answer questions. If the participant consents and signs, they will then be screened to ensure inclusion/exclusion by answering screening questions.
Once they have consented and met study inclusion/exclusion the participants will then be randomized into 1 of 2 groups by picking a number out of an envelope. Group 1 will receive a more extensive education session (10-15 min) on the benefits of exercise and EIH. Group 2 will receive a brief education session (1 minute) on the benefits of exercise and EIH. Next participants will complete basic demographic information: age, gender, history of injuries, athletic participation history, and Knowledge and Beliefs about Exercise and Pain Questionnaire (questions 1 -4).
Then they will be introduced and tested for pain pressure threshold (PPT). This standard measurement assesses the threshold when a pressure applied to the body passes from pressure to pain. A PPT algometer with a 1 cm tip is used to apply pressure to a body part slowly. When the participant first feels the sensation of pain, the pressure being applied is stopped and the amount of force is recorded as the individual's PPT. The participant will initially be introduced to the testing at the web space of the thumb and index finger on their dominant hand, this is done 3 times with minimum 15 seconds between each measurement and the average of the 3 measurements is used.
Participants then will receive the education about EIH depending on their group allocation last 1 minute or 10-15 minutes. After the education, the participants will be asked question #5 on the Knowledge and Beliefs about exercise and pain questionnaire. Both groups will be shown a picture of the exercise (wall squat) that they will perform and provided instruction on the exercise before they begin. The wall squat exercise will consist of standing upright with their back against the wall with feet 45 cm from the wall, feet parallel and shoulder width apart, and hands at their side. They will slide down the wall bending at the hips and knees, keeping their back against the wall and feet in place until their knee joint angle reaches 100 degrees of flexion measured by the study personnel. All participants are asked to maintain the position for 3 minutes or until fatigued and need to stop.
Prior to beginning the wall squat exercise, participants are asked to rate the intensity of pain in their legs using the Numeric Rating Scale (NRS=0-10, 0=no pain, 10=worst imaginable pain). Pain Pressure Threshold will be measured on the dominant quadriceps muscle and the non-dominate upper trapezius muscle. During the exercise, the NRS and category-ration scale of Rating of Perceived Exertion (CR 10, 0=nothing at all, 10=extremely strong) will be measured while performing the exercise at 1 minute, 2 minutes, and 3 minutes. Immediately post-exercise, Pain Pressure Threshold will be measured again on the dominant quadriceps muscle and the non-dominate upper trapezius muscle. The participants will also be asked to assess exercise expectations on EIH immediately post-exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short education | Active Comparator | Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia |
|
| Long education | Active Comparator | Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education on effects of Exercise-induced hypoalgesia from exercise | Behavioral | Educational session with participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Pressure Threshold | Measurement in kg/cm2, higher score is better outcome | 3 minutes post exercise on Day following educational session and exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge and Beliefs About Exercise and Pain Questionnaire | paper questionnaire on Likert scale 1 strongly disagree, 5 strongly agree. higher number indicates more knowledge. | 3 minutes post exercise on Day following educational session and exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kory Zimney, DPT, PT | University of South Dakota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Dakota | Vermillion | South Dakota | 57069 | United States |
upon request
Upon completion of study for 3 years after closing study.
email PI at kory.zimney@usd.edu for data
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Education | Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants |
| FG001 | Long Education | Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Education | Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants |
| BG001 | Long Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Pressure Threshold | Measurement in kg/cm2, higher score is better outcome | Posted | Mean | Standard Deviation | kg/cm^2 | 3 minutes post exercise on Day following educational session and exercise |
|
Participants were assessed during the intervention of the exercise protocol (3 imuntes) and for a follow-up of 10 minutes post exercise, they were to report any changes that may be due to adverse event for 3 days post exercise.
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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 | Short Education | Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kory Zimney | USouthDakota | 6056586373 | kory.zimney@usd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2023 | Sep 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2023 | Nov 21, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants will be randomized into 1 of 2 groups. Outcome assessor will not be informed of participant grouping.
Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Knowledge and Beliefs About Exercise and Pain Questionnaire | paper questionnaire on Likert scale 1 strongly disagree, 5 strongly agree. higher number indicates more knowledge. | Posted | Mean | Standard Deviation | units on a scale | 3 minutes post exercise on Day following educational session and exercise |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Long Education | Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia Education on effects of Exercise-induced hypoalgesia from exercise: Educational session with participants | 0 | 5 | 0 | 5 | 0 | 5 |
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