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Completed

NCT Number: NCT06229691

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.

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Key information

Conditions

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

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Minimum toe clearance during walking

    Time frame: Beginning and end of 30 minute treadmill walk

    Minimum toe clearance will be calculated from the first and last minutes of the treadmill walk using optical motion capture.

  2. Anterior stability margins during walking

    Time frame: Beginning and end of 30 minute treadmill walk

    Anterior stability margins will be calculated from the first and last minutes of the treadmill walk using optical motion capture.

  3. Anterior reactive stepping

    Time frame: Beginning and end of 30 minute treadmill walk

    Stability margins will be calculated from a lean-release test conducted before and after the 30 minute treadmill walk

  4. Knee extensor fatigability

    Time frame: Before and after the 30 minute treadmill walk

    Knee extensor fatigability will be calculated as the change in maximum knee extensor power (measured via dynamometry) pre- to post-30 minute treadmill walk

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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