Osteoarthritis, KneeNCT06229691
Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis
A study testing 30 minute treadmill walk in people with Osteoarthritis, Knee, run by University of Delaware at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- 30 minute treadmill walk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 30 minute treadmill walk
- Keywords
- balance, fatigue, falls
- Medical subject headings
- Osteoarthritis, Knee, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 minute treadmill walkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Not described Receives: Behavioral: 30 minute treadmill walk |
| Knee osteoarthritis | Experimental | Not described Receives: Behavioral: 30 minute treadmill walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Before and after the 30 minute treadmill walk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start14 May 2024
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229691
- Sponsor's protocol ID
- 1924071
- Other IDs
- U54GM104941
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06229691
- Acronym / sponsor ID
- 1924071
- Conditions
- Osteoarthritis, Knee
- Keywords
- balance, fatigue, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Behavioral: 30 minute treadmill walk |
| Knee osteoarthritis | Experimental | Behavioral: 30 minute treadmill walk |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of occasional to frequent knee pain
- knee pain that is primarily in the medial knee joint compartment
- minimal morning joint stiffness
- able to walk continuously for 30 minutes without an assistive device
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 minute treadmill walkParticipants 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. | Behavioural | Healthy, Knee osteoarthritis |
Primary outcome
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 minute treadmill walk in people with Osteoarthritis, Knee, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum toe clearance during walking (time frame: Beginning and end of 30 minute treadmill walk). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.