Clinical trial NCT04775589: Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
Official title: Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Exercise
Physical Therapy
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2021-03-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: 30-second chair stand test
timeFrame: Baseline to 6 months
measure: 2 minute march test
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Healthcare System
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Kelli Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: