Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06105788

Upper and Lower Extremity Exercise and Exercise-Induced Hypoalgesia in Knee Osteoarthritis

Comparing Effects of Upper Extremity Versus Lower Extremity Exercise on Exercise-Induced Hypoalgesia in People With Knee Osteoarthritis: A Pilot Cross-over Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of Texas, El Paso · Academic / Other
Sex
All
Age
45 Years – 90 Years
Healthy volunteers
Accepted

Summary

The objective of the study is to explore the effects of arm exercise (UE, arm ergometer) vs. leg exercise (LE, cycling ergometer) on exercise-induced hypoalgesia (EIH), central pain mechanisms and knee pain in people with knee osteoarthritis (OA). Furthermore, we will explore relations of socioeconomic status, racial discrimination, acculturative stress, and autonomic function to exercise effects on EIH, central pain mechanisms, and knee pain. This will be a pilot randomized cross-over study where all participants undergo Day 1 (baseline assessments), Day 2 (UE or LE), and Day 3 (UE or LE).

Detailed description

This will be a pilot randomized cross-over study. Major exclusion criteria will be conditions that have risks with exercise or affect pain assessments. Once enrolled, all participants will undergo 3 laboratory visits, each separated at least by a week as a wash-out period: day 1, baseline assessment; day 2, randomized to either upper extremity exercise (UEE) (i.e., arm ergometer) or knee exercise (KE) (i.e., cycling ergometer); and day 3, UEE or KE alternative to the exercise on day 2. UEE will be an arm-ergometer and KE will be a cycle-ergometer in which participants will undergo the first 5 minutes at an intensity of 50% heart rate reserve (HRR)(warm-up period), followed by 20 minutes at 70% HRR. Heart rate will be monitored during the exercise. On day 1, we will collect participant characteristics data. We will also collect data related to race/ethnicity, racial discrimination, acculturative stress, physical activity level, heart rate variability (HRV) parameters (measures of autonomic function). Further, participants will undergo knee pain assessment with a 20-meter walk, quantitative sensory testing (QST) measures of pressure pain threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM) as surrogate measures of central pain mechanisms. On Days 2 and 3 we will collect knee pain, QST, and EIH data before and immediately after the exercise.

Conditions

Interventions

TypeNameDescription
OTHERExerciseArm exercise will be an arm ergometer for 20 minutes, preceded by a 5-minute warm-up. Leg exercise will be a cycling ergometer for 20 minutes, preceded by a 5-minute warm-up. The exercise intensity will be set at 70% of the heart rate reserve (HRR) for each type of exercise.

Timeline

Start date
2023-11-15
Primary completion
2025-10-16
Completion
2025-10-16
First posted
2023-10-30
Last updated
2024-12-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06105788. Inclusion in this directory is not an endorsement.