- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561582
The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise
October 30, 2024 updated by: Abigail Wilson, University of Central Florida
The primary purpose of this study is to to compare immediate changes in pressure pain threshold at the exercising muscle (quadriceps) and a non-exercising muscle (upper trapezius) during low and high weight knee extension exercise.
Participants will attend one session that consists of pain sensitivity testing, completion of pain-related psychological questionnaires, and random assignment to one of three interventions: 1) knee extension exercise with a high weight, 2) knee extension exercise with a low weight, or 3) quiet rest.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32765
- University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pain-free
- 18-60 years old
- Participant can appropriately perform the knee extension exercise (assessed during screening)
Exclusion Criteria:
- Non-English speaking
- Regular use of prescription pain medications
- Current or history of chronic pain condition
- Currently taking blood-thinning medication
- Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
- Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
- Known presence of cardiovascular, pulmonary, or metabolic disease
- Current use of tobacco products
- Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- Surgery, injury, or fracture to the lower back or lower extremity within the past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Exercise
Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
|
Participants will be seated in a resistance exercise machine.
Weight corresponding to the assigned group will be added to the machine.
Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
|
Experimental: Low Intensity Exercise
Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
|
Participants will be seated in a resistance exercise machine.
Weight corresponding to the assigned group will be added to the machine.
Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
|
No Intervention: Quiet Rest
Participants will sit quietly for two minutes, three times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: 1 day
|
A digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each.
Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conditioned Pain Modulation
Time Frame: 1 day
|
Pressure pain threshold after an cold water immersion task will be measured.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abigail Wilson, University of Central Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2022
Primary Completion (Actual)
March 27, 2023
Study Completion (Actual)
March 27, 2023
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
September 27, 2022
First Posted (Actual)
September 30, 2022
Study Record Updates
Last Update Posted (Estimated)
December 9, 2024
Last Update Submitted That Met QC Criteria
October 30, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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