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

NCT06229691 | Completed

• 2 other identifiers: 1924071U54GM104941
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

balance; fatigue; falls

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Healthy

EXPERIMENTAL

Behavioral: 30 minute treadmill walk

Knee osteoarthritis

EXPERIMENTAL

Behavioral: 30 minute treadmill walk

Interventions

30 minute treadmill walk BEHAVIORAL

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.

Healthy; Knee osteoarthritis

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Fatigue

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 29, 2024
• Study Start: May 14, 2024
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: May 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)