HealthyNCT05525403
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
A study testing Knee Extension Exercise and Quiet Rest in people with Healthy, run by University of Central Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Knee Extension Exercise and Quiet Rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain-free
- 18-60 years old
- Participant can appropriately perform the knee extension exercise (assessed during screening)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32765
About this study
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Knee Extension Exercise, Quiet Rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Extension ExerciseOther
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.
Quiet RestOther
Participants will sit quietly for two minutes, three times.
| Study group | Role | What they receive |
|---|---|---|
| Low Fatigue Exercise | Experimental | 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. Receives: Other: Knee Extension Exercise |
| High Fatigue Exercise | Experimental | 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. Receives: Other: Knee Extension Exercise |
| Quiet Rest | Active comparator | Participants will rest quietly for two minutes, three sets. Receives: Other: Quiet Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure Pain Threshold
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.
Measured: Change from baseline immediately after exercise
Secondary outcomes (10)
Temporal Summation
Participants will rate a train of 10 heat pulses using the 101-point numerical pain rating scale
Measured: Baseline, pre exercise
Heat Pain Threshold
A thermode will gradually increase temperature. Participants will state when the sensation first becomes painful.
Measured: Baseline, pre exercise
Conditioned Pain Modulation
Pressure pain threshold after an ice water immersion task will be measured.
Measured: Baseline, pre exercise
International Physical Activity Questionnaire Short Form
This is a self-report measure of physical activity that provides data regarding health-related physical activity.
Measured: Baseline, pre exercise
Pittsburgh Sleep Quality Index
This is a 10-item questionnaire in which individuals respond to statements regarding sleep quality. A higher score indicates a worse sleep quality.
Measured: Baseline, pre exercise
Pain Catastrophizing Scale
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.
Measured: Baseline, pre exercise
Fear of Pain Questionnaire 9
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.
Measured: Baseline, pre exercise
Pain Anxiety Symptom Scale
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.
Measured: Baseline, pre exercise
Brief Resilience Scale
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.
Measured: Baseline, pre exercise
Preference for and Tolerance of the Intensity of Exercise Questionnaire
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.
Measured: Baseline, pre exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start28 Oct 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Wilson, University of Central Florida
- Investigators
- Abigail Wilson, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525403
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
- ClinicalTrials.gov ID
- NCT05525403
- Acronym / sponsor ID
- 2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Fatigue Exercise | Experimental | Other: Knee Extension ExerciseParticipants 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. |
| High Fatigue Exercise | Experimental | Other: Knee Extension ExerciseParticipants 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. |
| Quiet Rest | Active comparator | Other: Quiet RestParticipants will rest quietly for two minutes, three sets. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pain-free
- 18-60 years old
- Participant can appropriately perform the knee extension exercise (assessed during screening)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Knee Extension ExerciseParticipants 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. | Other | High Fatigue Exercise, Low Fatigue Exercise |
| Quiet RestParticipants will sit quietly for two minutes, three times. | Other | Quiet Rest |
Primary outcome
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.
10 secondary outcomes
Temporal Summation
Time frame: Baseline, pre exercise
Heat Pain Threshold
Time frame: Baseline, pre exercise
Conditioned Pain Modulation
Time frame: Baseline, pre exercise
International Physical Activity Questionnaire Short Form
Time frame: Baseline, pre exercise
Pittsburgh Sleep Quality Index
Time frame: Baseline, pre exercise
Pain Catastrophizing Scale
Time frame: Baseline, pre exercise
Fear of Pain Questionnaire 9
Time frame: Baseline, pre exercise
Pain Anxiety Symptom Scale
Time frame: Baseline, pre exercise
Brief Resilience Scale
Time frame: Baseline, pre exercise
Preference for and Tolerance of the Intensity of Exercise Questionnaire
Time frame: Baseline, pre exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Abigail Wilson principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Extension Exercise and Quiet Rest in people with Healthy, run by University of Central Florida 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 10 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 24 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pressure Pain Threshold (time frame: Change from baseline immediately after 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 24 Apr 2023.