Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis

The goal of this clinical trial is to learn about how fatigue affects the risk of falling in adults aged 55-70 years with and without knee osteoarthritis. The main questions this trial aims to answer are:

• Does fatigue increase the risk of tripping while walking? and
• Does fatigue increase the risk of falling in response to a trip while walking? Participants will
• Complete questionnaires
• Wear a device that measures physical activity for 5-7 days
• Complete a 30 minute walk on a treadmill

• Complete the following before and after the treadmill walk:

  • Computer test to measure mental fatigue
  • Maximal strength testing
  • Balance test

Researchers will compare adults with and without knee osteoarthritis to see if fall risk in adults with knee osteoarthritis is affected more by walking activity compared to adults without knee osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: 30 minute treadmill walk

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For adults with knee osteoarthritis:

• presence of occasional to frequent knee pain
• knee pain that is primarily in the medial knee joint compartment
• minimal morning joint stiffness

For all participants:

• able to walk continuously for 30 minutes without an assistive device

Exclusion Criteria:

• fracture or surgery within 1 year
• history of joint replacement
• lower-extremity joint injections within 3 months
• history of stroke or other neurological condition
• cardiovascular or pulmonary conditions that limit daily activity or that preclude participation in exercise
• history of major lower extremity or back injury or pain (except for knee osteoarthritis)
• history of lower extremity amputation
• use an orthotic or prosthetic to walk
• use of beta blockers or other medications that affect fatigue
• use of medications that affect balance
• diabetic neuropathy
• acute illness or the presence of lesions on the torso or lower extremities
• BMI greater than 35
• body weight over 265 lbs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy	Behavioral: 30 minute treadmill walk; Participants will walk on a treadmill at their preferred speed for 30 minutes. One minute "challenge" periods will occur at minutes 7, 17, and 27, when the treadmill speed will increase by 50%. This walk will induce a magnitude of muscle fatigue corresponding to an individual participant's fatigability.
Experimental: Knee osteoarthritis	Behavioral: 30 minute treadmill walk; Participants will walk on a treadmill at their preferred speed for 30 minutes. One minute "challenge" periods will occur at minutes 7, 17, and 27, when the treadmill speed will increase by 50%. This walk will induce a magnitude of muscle fatigue corresponding to an individual participant's fatigability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum toe clearance during walking	Minimum toe clearance will be calculated from the first and last minutes of the treadmill walk using optical motion capture.	Beginning and end of 30 minute treadmill walk
Anterior stability margins during walking	Anterior stability margins will be calculated from the first and last minutes of the treadmill walk using optical motion capture.	Beginning and end of 30 minute treadmill walk
Anterior reactive stepping	Stability margins will be calculated from a lean-release test conducted before and after the 30 minute treadmill walk	Beginning and end of 30 minute treadmill walk
Knee extensor fatigability	Knee extensor fatigability will be calculated as the change in maximum knee extensor power (measured via dynamometry) pre- to post-30 minute treadmill walk	Before and after the 30 minute treadmill walk

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Actual): August 27, 2025
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; falls; balance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoarthritis, Knee; Fatigue
• Other Study ID Numbers: 1924071; U54GM104941 (U.S. NIH Grant/Contract)

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