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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229691
• Other study ID #: 1924071
• Secondary ID: U54GM104941
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University of Delaware
• Contact: Jocelyn F Hafer, PhD
• Phone: 3028313471
• Email: jfhafer[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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