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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Knee Extension Exercise
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.
Other: Knee Extension Exercise
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.
Other: Quiet Rest
Participants will sit quietly for two minutes, three times.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2 (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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