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Active Not RecruitingNCT04775589

Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Durham VA Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALStepped Exercise for Knee OsteoarthritisPatients start with a home-based 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

Timeline

Start date
2021-06-03
Primary completion
2025-03-15
Completion
2025-03-15
First posted
2021-03-01
Last updated
2025-02-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04775589. Inclusion in this directory is not an endorsement.