- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05525403
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
April 20, 2023 updated by: Abigail Wilson, University of Central Florida
The primary purpose of this study is to compare immediate changes in pain sensitivity (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will attend three sessions.
Participants will fill out questionnaires, undergo pain sensitivity testing, and be randomly assigned to complete a high and low fatigue exercise on either the second or third session.
During the exercise, participants will complete three sets of a single leg knee extension exercise with weight equivalent to 50% of their 1 repetition maximum until they report either a high or low fatigue level.
Immediately before and after each set, the research team will examine immediate changes in sensitivity to pressure (pressure pain threshold).
Study Type
Interventional
Enrollment (Actual)
31
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
14 years to 56 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 (blood pressure over 140/90 mmHg), 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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Fatigue Exercise
Participants will complete a single leg knee extension exercise with weight until they report a fatigue level = 3/10 on the Borg Rating of Perceived Exertion.
Participants will complete three sets.
|
Participants will be seated in a Steel Flex machine with weight equal to 50% of their 1 repetition maximum added to the machine.
Participants will extend the dominant knee until the assigned fatigue level.
|
|
Experimental: High Fatigue Exercise
Participants will complete a single leg knee extension exercise with weight until they report a fatigue level = 8/10 on the Borg Rating of Perceived Exertion.
Participants will complete three sets.
|
Participants will be seated in a Steel Flex machine with weight equal to 50% of their 1 repetition maximum added to the machine.
Participants will extend the dominant knee until the assigned fatigue level.
|
|
Active Comparator: Quiet Rest
Participants will rest quietly for two minutes, three sets.
|
Participants will sit quietly for two minutes, three times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Pain Threshold
Time Frame: Change from baseline immediately after exercise
|
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.
|
Change from baseline immediately after exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporal Summation
Time Frame: Baseline, pre exercise
|
Participants will rate a train of 10 heat pulses using the 101-point numerical pain rating scale
|
Baseline, pre exercise
|
|
Heat Pain Threshold
Time Frame: Baseline, pre exercise
|
A thermode will gradually increase temperature.
Participants will state when the sensation first becomes painful.
|
Baseline, pre exercise
|
|
Conditioned Pain Modulation
Time Frame: Baseline, pre exercise
|
Pressure pain threshold after an ice water immersion task will be measured.
|
Baseline, pre exercise
|
|
International Physical Activity Questionnaire Short Form
Time Frame: Baseline, pre exercise
|
This is a self-report measure of physical activity that provides data regarding health-related physical activity.
|
Baseline, pre exercise
|
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline, pre exercise
|
This is a 10-item questionnaire in which individuals respond to statements regarding sleep quality.
A higher score indicates a worse sleep quality.
|
Baseline, pre exercise
|
|
Pain Catastrophizing Scale
Time Frame: Baseline, pre exercise
|
This is a 13-item questionnaire in which individuals respond to a statement on a five point scale from 0 to 4. Higher scores indicate higher pain catastrophizing levels.
|
Baseline, pre exercise
|
|
Fear of Pain Questionnaire 9
Time Frame: Baseline, pre exercise
|
This is a 9-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate higher fear of pain.
|
Baseline, pre exercise
|
|
Pain Anxiety Symptom Scale
Time Frame: Baseline, pre exercise
|
This is a 20-item questionnaire in which individuals respond to a statement on a six point scale from 0 to 5. Higher scores indicate higher pain-related anxiety.
|
Baseline, pre exercise
|
|
Brief Resilience Scale
Time Frame: Baseline, pre exercise
|
This is a 6-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate greater resilience.
|
Baseline, pre exercise
|
|
Preference for and Tolerance of the Intensity of Exercise Questionnaire
Time Frame: Baseline, pre exercise
|
This is a 16-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate lower tolerance for the intensity of exercise.
|
Baseline, pre exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-repetition maximum testing
Time Frame: Baseline, pre exercise
|
The amount of weight that can be lifted for 1 repetition
|
Baseline, pre exercise
|
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 28, 2022
Primary Completion (Actual)
April 20, 2023
Study Completion (Actual)
April 20, 2023
Study Registration Dates
First Submitted
August 22, 2022
First Submitted That Met QC Criteria
August 30, 2022
First Posted (Actual)
September 1, 2022
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)
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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