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The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knee Extension Exercise
Quiet Rest
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Central Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low Fatigue Exercise

High Fatigue Exercise

Quiet Rest

Arm Description

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 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 rest quietly for two minutes, three sets.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Temporal Summation
Participants will rate a train of 10 heat pulses using the 101-point numerical pain rating scale
Heat Pain Threshold
A thermode will gradually increase temperature. Participants will state when the sensation first becomes painful.
Conditioned Pain Modulation
Pressure pain threshold after an ice water immersion task will be measured.
International Physical Activity Questionnaire Short Form
This is a self-report measure of physical activity that provides data regarding health-related physical activity.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 22, 2022
Last Updated
April 20, 2023
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05525403
Brief Title
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
Official Title
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Fatigue Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
High Fatigue Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Quiet Rest
Arm Type
Active Comparator
Arm Description
Participants will rest quietly for two minutes, three sets.
Intervention Type
Other
Intervention Name(s)
Knee Extension Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quiet Rest
Intervention Description
Participants will sit quietly for two minutes, three times.
Primary Outcome Measure Information:
Title
Change in Pressure Pain Threshold
Description
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.
Time Frame
Change from baseline immediately after exercise
Secondary Outcome Measure Information:
Title
Temporal Summation
Description
Participants will rate a train of 10 heat pulses using the 101-point numerical pain rating scale
Time Frame
Baseline, pre exercise
Title
Heat Pain Threshold
Description
A thermode will gradually increase temperature. Participants will state when the sensation first becomes painful.
Time Frame
Baseline, pre exercise
Title
Conditioned Pain Modulation
Description
Pressure pain threshold after an ice water immersion task will be measured.
Time Frame
Baseline, pre exercise
Title
International Physical Activity Questionnaire Short Form
Description
This is a self-report measure of physical activity that provides data regarding health-related physical activity.
Time Frame
Baseline, pre exercise
Title
Pittsburgh Sleep Quality Index
Description
This is a 10-item questionnaire in which individuals respond to statements regarding sleep quality. A higher score indicates a worse sleep quality.
Time Frame
Baseline, pre exercise
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
Baseline, pre exercise
Title
Fear of Pain Questionnaire 9
Description
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.
Time Frame
Baseline, pre exercise
Title
Pain Anxiety Symptom Scale
Description
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.
Time Frame
Baseline, pre exercise
Title
Brief Resilience Scale
Description
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.
Time Frame
Baseline, pre exercise
Title
Preference for and Tolerance of the Intensity of Exercise Questionnaire
Description
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.
Time Frame
Baseline, pre exercise
Other Pre-specified Outcome Measures:
Title
1-repetition maximum testing
Description
The amount of weight that can be lifted for 1 repetition
Time Frame
Baseline, pre exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail Wilson
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32765
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise

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