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Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
NCT04775589 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.
Conditions Studied
Interventions
- BEHAVIORAL Stepped Exercise for Knee Osteoarthritis
Study Locations (1)
North Carolina
- Durham VA Healthcare System — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2025-03-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775589
The ClinicalTrials.gov registry entry for NCT04775589 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durham VA Medical Center, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which Stepped Exercise for Knee Osteoarthritis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04775589 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04775589 about?
NCT04775589 is a clinical study titled "Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis". The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pai...
What is the current status of trial NCT04775589?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 19 participants. The study started on 2021-06-03. Estimated completion is 2025-03-15.
What conditions does trial NCT04775589 study?
This clinical trial studies the following conditions: Knee Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04775589?
The interventions under investigation include: Stepped Exercise for Knee Osteoarthritis (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04775589?
This trial is sponsored by Durham VA Medical Center, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04775589 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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