Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

NCT04775589 | Active Not Recruiting

• 1 other identifier: 15997
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

Exercise; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index

  24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms.

  Baseline to 6 months

Secondary Outcomes (2)

• 30-second chair stand test

  Baseline to 6 months

• 2 minute march test

  Baseline to 6 months

Study Arms (1)

Stepped Exercise for Knee Osteoarthritis

EXPERIMENTAL

Patients 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.

Behavioral: Stepped Exercise for Knee Osteoarthritis

Interventions

Stepped Exercise for Knee Osteoarthritis BEHAVIORAL

Patients 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

Stepped Exercise for Knee Osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rural dwelling Veterans (VA healthcare users)
• Clinician diagnosis of knee osteoarthritis
• Self-reported knee pain =\>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing.

You may not qualify if:

• Advanced Dementia
• Psychosis
• Active substance abuse disorder
• Meniscus or ACL tear in the past 6 months
• Total joint replacement or other major lower extremity surgery in the past 6 months
• Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components)
• Serious / terminal illness
• Unstable angina
• History of ventricular tachycardia
• Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
• Uncontrolled hypertension (diastolic blood pressure \>110 mm/Hg or systolic \> 200mm/Hg)
• Stroke with moderate to severe aphasia
• Recent history of falls
• Resident of a long-term care facility
• Hospitalization for a cardiovascular condition in the past 3 months

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VA Healthcare System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Kelli Allen, PhD

  Durham VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: June 3, 2021
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)