# A Feasibility and Pilot Study of Combined Treatment Protocol using Aerobic Exercise and Duloxetine in Older Adults with Symptomatic Knee Osteoarthritis and Comorbid Depression

> **NIH NIH K01** · UNIVERSITY OF MARYLAND BALTIMORE · 2020 · $123,731

## Abstract

Symptomatic knee osteoarthritis (OA) affects 10% of men and 13% of women 60 years or older, and
depressive symptoms are common, estimated to be prevalent in one-fifth of these patients. Depressive
symptoms worsen knee OA disease severity and are a barrier to pain management and engagement in
physical activity. Clinical care guidelines recommend depression treatment in older adults with knee OA but
provide no direction on how to simultaneously manage both conditions, and patients are often not treated for
their depressive symptoms and receive interventions only for their chronic physical illness. This issue is
exacerbated by the routine exclusion of individuals with chronic physical diseases and comorbid depression
from clinical trials and lack of protocols designed for these patients. Recent research advocates the use of
treatments that benefit both conditions simultaneously, or combined treatment using two interventions in
parallel that are designed to work together, such that approaches enhance efficacy beyond that of an individual
therapy with a single disease target. Treatment guidelines advise exercise programs to manage pain and
disability and improve psychosocial health in those with knee OA, but compliance to physical activity protocols
is low in persons with chronic pain and disability and is only made worse by comorbid depression. Adherence
is critical to the efficacy of depression treatments using exercise training, and no such exercise program has
ever been designed for and tested in OA patients with co-occurring depressive symptoms in a way to enhance
compliance. Duloxetine is the only antidepressant medication indicated for pain management in knee OA
patients that has demonstrated efficacy and tolerability when treating depression in older adults, and therefore,
is a viable pharmacological complement to exercise training. There are no protocols that combine treatments
using interventions that affect symptoms of both knee OA and depression, and a strategy focused on co-
management of the two conditions could be disseminated to and implemented by generalist medical
practitioners. Thus, the research goal of this K01 application is to evaluate the feasibility of and then pilot test a
protocol comprised of aerobic exercise training plus duloxetine for the treatment of symptomatic knee OA and
comorbid depression. The proposed research will be implemented with a period of close mentoring and career
development activities focused on learning 1) methods for qualitative data collection and analysis that can be
used to understand patients’ perspectives and experiences and 2) strategies for the implementation and
evaluation of interventions in clinical research. This proposal is aligned with the NIA Strategic Directions for
Research on Aging emphasizing older adults with multiple chronic conditions that complicate clinical care and
is intended to lead to a research program that uses observational epidemiology evaluating the relationships
and me...

## Key facts

- **NIH application ID:** 9969296
- **Project number:** 5K01AG064041-02
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Alan Michael Rathbun
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $123,731
- **Award type:** 5
- **Project period:** 2019-07-15 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969296

## Citation

> US National Institutes of Health, RePORTER application 9969296, A Feasibility and Pilot Study of Combined Treatment Protocol using Aerobic Exercise and Duloxetine in Older Adults with Symptomatic Knee Osteoarthritis and Comorbid Depression (5K01AG064041-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969296. Licensed CC0.

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