Biopsychosocial Factors in Resistance Exercise in Individuals with Knee Pain

The purpose of this research is to examine changes in pain sensitivity during high fatigue exercise, low fatigue exercise, and no treatment in individuals who are currently experiencing knee pain. Dosing dynamic resistance exercise intensity based on fatigue level is a novel, clinically feasible method. Dynamic resistance exercise at a high intensity (75% 1 repetition maximum (RM)) produces significant hypoalgesia at local sites compared to no treatment; however, dosing intensity based on 1RM can be challenging to implement in the clinical setting. Fatiguing endurance tasks produce local and systemic reductions in pressure pain threshold with low intensity isometric exercise completed until failure resulting in the largest exercise induced hypoalgesia effects. Fatigue may be an important mediator in pain response to exercise.

Study Overview

• Status: Completed
• Conditions: Knee Pain
• Intervention / Treatment: Other: Leg Extension Exercise

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32765
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Experiencing knee pain symptom intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria:

• non-English speaking
• history of knee surgery or fracture within the past 6 months
• history of quadriceps tendon rupture
• history of a chronic pain condition, such as fibromyalgia
• systemic medical conditions that affect sensation, such as uncontrolled diabetes or neurological conditions
• blood clotting disorder, such as hemophilia
• known presence of cardiovascular, pulmonary, or metabolic disease
• current use of tobacco products
• contraindication to the application of ice, including blood pressure over 140/90 mmHg, -conditions that cause hives or blood in urine when exposed to cold, and any reductions in blood flow to arms or legs.
• not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire + (PAR-Q+)
• pain during active knee range of motion 0-90 degrees (examined during screening)
• Pregnant
• unable to attend 4 sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Quiet Rest; Participants will sit quietly for two minutes, three times. Pressure pain threshold will be measured between each two-minute interval.
Experimental: High Fatigue Exercise; Participants will perform a leg extension exercise in a machine with weight equipment to 65% of their 1-repetition maximum. Participants will complete this exercise for three sets until they report the exercise is "hard" (8/10 on the OMNI perceived exertion scale).	Other: Leg Extension Exercise; Participants will perform a concentric quadriceps contraction into terminal knee extension with weight equivalent to 65% of a1-repetition maximum.
Active Comparator: Low Fatigue Exercise; Participants will perform a leg extension exercise in a machine with weight equipment to 65% of their 1-repetition maximum. Participants will complete this exercise for three sets until they report the exercise is "somewhat easy" (4/10 on the OMNI perceived exertion scale).	Other: Leg Extension Exercise; Participants will perform a concentric quadriceps contraction into terminal knee extension with weight equivalent to 65% of a1-repetition maximum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold	A computerized pressure algometer (AlgoMed, Ramat Yishai, Israel) with a 1 cm diameter rubber tip will be applied at a constant rate. Participants will be instructed to say 'stop' or 'pain' or press a response button connected to the algometer so that stimulus can be terminated when the sensation first changes from pressure to pain (pain threshold). This will be applied to the quadriceps and upper trapezius on the same side as the participant's knee pain.	This procedure will be completed two times before and after each set of exercise with the average analyzed. Outcomes are examined during each intervention visit from enrollment to study completion, about 2 years.

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Abigail Wilson, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 7

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
• product manufactured in and exported from the U.S.: No