Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04775589
• Other study ID #: 15997
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Durham VA Medical Center
• Contact: Kelli Allen, PhD
• Phone: 919-286-6936
• Email: kelli.allen[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Other health conditions that would make home exercise unsafe or participation in the program not feasible

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Stepped Exercise for Knee Osteoarthritis
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Durham VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-second chair stand test	Participants are asked to rise and sit back down in a chair as many times as they can during 30 seconds, without using hands or arms for support. Higher numbers of chair stands indicate better function.	Baseline to 6 months
Secondary	2 minute march test	Participants are asked to march in place, taking as many "steps" as they can within 2 minutes, bringing the knees to approximately a 90-degree angle. If the patient is not bringing knees to an appropriate height, the study team member administering the test will ask them to raise their knees higher; if proper knee height cannot be maintained, the patient may continue the test, but this is noted on the score sheet. Higher numbers of steps indicate better function.	Baseline to 6 months