ExerciseNCT05658224
Education Time Influence on Exercise-Induced Hypoalgesia
A study testing Education on effects of Exercise-induced hypoalgesia from exercise in people with Exercise, run by University of South Dakota at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Education on effects of Exercise-induced hypoalgesia from exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and understand English,
- Refrained from alcohol, pain medication, and vigorous exercise for the past 24 hours,
- No history of chronic pain (pain > 3 months), or current pain/injury that would prevent the ability to do exercise.
Who cannot join
- unable to meet screening questions for PAR-Q+ for safe exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Dakota
Vermillion, South Dakota, 57069
About this study
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.
Read the detailed description
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.
- Conditions
- Exercise
- Being tested
- Education on effects of Exercise-induced hypoalgesia from exercise
- Keywords
- Exercise induced hypoalgesia, Education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on effects of Exercise-induced hypoalgesia from exerciseBehavioural
Educational session with participants
| Study group | Role | What they receive |
|---|---|---|
| Short education | Active comparator | Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia Receives: Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise |
| Long education | Active comparator | Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia Receives: Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold
Measurement in kg/cm2, higher score is better outcome
Measured: 3 minutes post exercise on Day following educational session and exercise
Secondary outcomes (1)
Knowledge and Beliefs About Exercise and Pain Questionnaire
paper questionnaire on Likert scale 1 strongly disagree, 5 strongly agree. higher number indicates more knowledge.
Measured: 3 minutes post exercise on Day following educational session and exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Nov 2022
- Primary completion15 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kory Zimney, PT, DPT, PhD, University of South Dakota
- Investigators
- Kory Zimney, DPT, PT, Principal investigator, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658224
- Sponsor's protocol ID
- USouthDakota
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2022
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Time Influence on Exercise-Induced Hypoalgesia
- ClinicalTrials.gov ID
- NCT05658224
- Acronym / sponsor ID
- USouthDakota
- Conditions
- Exercise
- Keywords
- Exercise induced hypoalgesia, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South DakotaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short education | Active comparator | Behavioral: Education on effects of Exercise-induced hypoalgesia from exerciseIndividuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia |
| Long education | Active comparator | Behavioral: Education on effects of Exercise-induced hypoalgesia from exerciseIndividuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to read and understand English,
- Refrained from alcohol, pain medication, and vigorous exercise for the past 24 hours,
- No history of chronic pain (pain > 3 months), or current pain/injury that would prevent the ability to do exercise.
Key exclusion criteria (1 listed)
- unable to meet screening questions for PAR-Q+ for safe exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on effects of Exercise-induced hypoalgesia from exerciseEducational session with participants | Behavioural | Long education, Short education |
Primary outcome
Pain Pressure Threshold
Time frame: 3 minutes post exercise on Day following educational session and exercise
Measurement in kg/cm2, higher score is better outcome
1 secondary outcome
Knowledge and Beliefs About Exercise and Pain Questionnaire
Time frame: 3 minutes post exercise on Day following educational session and exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. upon request
Related trials for Exercise
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kory Zimney, DPT, PT principal investigator
University of South Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on effects of Exercise-induced hypoalgesia from exercise in people with Exercise, run by University of South Dakota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold (time frame: 3 minutes post exercise on Day following educational session and exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.