N/A N=240 Randomized Single-blind Treatment

Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (R33)

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT04533711 ↗

Enrolled (actual)

240

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) — -2.40; -10.8 Minutes per week — p=0.3086

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OA-PCP Intervention (Behavioral); Attention Control (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)	-2.40; -10.8	0.3086
PRIMARY Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)	1.72; -9.21	0.1820
SECONDARY Change From Baseline to Month 6 for Steps Per Day	-1.00; -309	0.094
SECONDARY Change From Baseline to Month 12 for Steps Per Day	-80.9; -433	0.0691
SECONDARY Change From Baseline to Month 6 for Minutes of Sedentary Activity	0.26; 6.11	0.4953
SECONDARY Change From Baseline to Month 12 for Minutes of Sedentary Activity	8.05; 10.30	0.8041
SECONDARY Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	-1.06; -1.12	0.9645
SECONDARY Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	-2.95; -0.27	0.0989
SECONDARY Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	-0.56; -0.70	0.7667
SECONDARY Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	-1.39; -0.52	0.0894

Summary

The purpose of this study is to test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources. This program will be compared to another program that provides education on a variety of topics important to understanding osteoarthritis (OA) and its care.

Eligibility Criteria

Inclusion Criteria

Age 65 or older
One other chronic health condition that qualified under Chronic Care Management (CCM) guidelines, including: diabetes, depression, hypertension, hyperlipidemia, heart failure, atrial fibrillation, ischemic heart disease, stroke/transient ischemic attack (TIA), peripheral vascular disease, Chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, rheumatoid arthritis, osteoarthritis, HIV/AIDS, chronic kidney disease, hepatitis (chronic & viral B & C) and osteoporosis
Current Joint Symptoms
Self-reported physical activity <150 minutes per week
Willing to make a change in PA over the next 3 months

Exclusion Criteria

Pain in chest when performing physical activity
Pain in chest when not performing physical activity
Loss of balance because of dizziness or loss of consciousness
Recommendation from doctor to only perform physical activity under medical supervision
No documented diagnosis of knee or hip OA
Dementia or other memory loss condition
Active diagnosis of psychosis
Active Substance abuse disorder
Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
Severe hearing or visual impairment
Serious/terminal illness as indicated by referral to hospice or palliative care
Unstable angina
Hospitalization for cardiovascular event in last 6 months
History of ventricular tachycardia
Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
Stroke with moderate to severe aphasia
Recent history (last 6 months) of three or more falls

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04533711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.