CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Physical Activity Promotionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04906499
NCT04906499N/ACompleted

Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

University of North Carolina, Chapel Hill·interventional·Posted May 28, 2021·Updated Jan 29, 2024

In Brief

A clinical study evaluating Physical Activity Promotion for Anterior Cruciate Ligament Injuries and 7 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed Summary

Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) with approximately 50% of patients developing PTOA within 20 years of injury or surgery. Knee joint mechanical loading measured via physical activity (i.e. daily steps) is insufficient in individuals after ACLR compared to uninjured individuals. Establishing the beneficial effects of physical activity to promote optimal free-living knee joint mechanical loading and improve knee joint health will aid in the development of cost-effective interventions that prevent PTOA and health burden of the disease.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 28, 2021
Enrollment StartAug 1, 2021
Primary CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.1 years ago

Interventions

Physical Activity Promotionbehavioral

After enrolling, participants will be outfitted with a Fitbit Charge 2 activity monitor. The monitor will be worn during all waking hours, and compliance will be considered as a day with ≥ 1,000 steps. Participants will complete a 14-day "run-in" observation period while wearing the Fitbit but no PA promotion will occur. Individuals who are noncompliant during the "run in" period (\<10 days with \<1,000 steps) will be removed. Participants will receive a text message each morning with a personalized, daily step count goal and a link used to confirm receipt of the goal. The preceding 10 days of step data will be rank ordered and the 60th percentile step count will be set as the goal for the next day.