Clinical Trial Finder

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 55 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06229691
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Delaware
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Arms & Interventions

Arms

Experimental: Healthy

Experimental: Knee osteoarthritis

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Delaware, Newark, Delaware

Status

Recruiting

Address

University of Delaware

Newark, Delaware, 19713

Site Contact

Jocelyn F Hafer

[email protected]

302-831-3471

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