BOOST-OA for Osteoarthritis

(BOOST-OA Trial)

Overseen By Jennifer M Gierisch, PhD MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with knee osteoarthritis maintain their home exercise routines during and after physical therapy. It tests a new approach called BOOST-OA, which includes special tools and health coaching to support exercise habits. Participants will either continue with regular physical therapy or receive additional support through BOOST-OA, involving ongoing coaching after therapy ends. Veterans with knee osteoarthritis, knee pain for at least three months, and difficulty walking or climbing stairs may be eligible to participate. As an unphased trial, this study offers Veterans the opportunity to explore innovative support methods to enhance their exercise routines and improve their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the BOOST-OA intervention is safe for Veterans with knee osteoarthritis?

Research has shown that app-based programs for osteoarthritis (OA) are generally safe. One study found these programs effective and safe for OA patients, suggesting that the BOOST-OA program, which focuses on behavior changes, could be well-tolerated by participants.

In studies related to exercise, only a few cases reported safety issues. However, no major safety concerns emerged compared to other treatments, indicating that the exercise components of BOOST-OA are likely safe for participants.

Overall, the evidence suggests that BOOST-OA should be a safe option for those joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BOOST-OA for osteoarthritis because it combines traditional physical therapy (PT) with an innovative behavioral approach. Unlike standard PT, which typically focuses only on exercises during sessions, BOOST-OA adds components aimed at initiating and maintaining healthy behaviors beyond the clinic. This includes personalized support from a health coach via phone or video calls, reinforcing exercise habits and encouraging regular physical activity over a full year. These elements are designed to sustain improvements and potentially enhance long-term outcomes for osteoarthritis patients.

What evidence suggests that BOOST-OA is effective for improving adherence to home exercise in knee osteoarthritis?

Research has shown that exercise and follow-up sessions can improve knee osteoarthritis (OA). Studies have found that strengthening exercises and aerobic activities lessen pain and enhance physical function for individuals with mild to moderate knee OA. This trial will compare two approaches: the BOOST-OA program and usual physical therapy care. BOOST-OA includes ongoing support and coaching, aiming to maintain improvements by focusing on both exercise and healthy habits. By encouraging adherence to beneficial exercise routines, BOOST-OA may lead to better movement and reduced pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Kelli Dominick Allen, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans with knee osteoarthritis who are receiving physical therapy. Participants should be willing to adhere to a home exercise program and participate in health coaching calls post-therapy. Specific eligibility criteria details were not provided.

Inclusion Criteria

My doctor confirmed I have knee osteoarthritis.

I have had knee pain for at least 3 months.

I have experienced knee pain on most days last month.

Exclusion Criteria

Dementia, psychosis or active substance abuse disorder

Serious / terminal illness

Uncontrolled hypertension (diastolic >110 mm/Hg or systolic > 200mm/Hg)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavior Initiation

Participants receive tools and activities to address outcome expectations, action self-efficacy, goal-setting, and monitoring during PT visits

3 months

At least 4 PT visits (in-person), spaced weekly

Behavior Maintenance

Participants receive health coaching calls addressing satisfaction with outcomes, relapse prevention planning, and independent monitoring

9 months

9 health coaching calls (phone or video)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BOOST-OA

Trial Overview The study tests 'BOOST-OA', an intervention aiming to improve exercise adherence among Veterans with knee OA. It includes tools and activities during PT, followed by health coaching calls for nine months after PT ends, focusing on goal-setting, monitoring, and relapse prevention.

How Is the Trial Designed?

Group I: BOOST-OA Experimental Treatment 1 Intervention

BOOST-OA includes components that are integrated into PT visits (concurrent), focused on behavior initiation, as well as components that occur after PT visits have ended (sequential), focused on behavior maintenance. Concurrent components will be delivered in conjunction with usual care PT visits. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly. PT visits must be also completed within 3 months. Sequential components will be delivered by a health coach via phone or video. Health coach sessions will be conducted every other week for the first 2 months (months 4-5), monthly for an additional 3 months (months 6- 8), and every other month for the last 4 months (months 9-12; 9 total contacts). Calls will address strengthening and stretching exercises (≥3 times per week), as well as overall physical activity (e.g., minutes / steps).

Group II: Usual PT Care (UC) Active Control 1 Intervention

UC will be delivered by trained clinicians at participating sites. The study team will provide clinicians with guidance and training to standardize core aspects of PT, aligned with best practice recommendations. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly so that Veterans can practice home exercise and receive guidance in exercise progression. All PT visits must be completed within 3 months.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29088393/

Exercise, Manual Therapy, and Booster Sessions in Knee ... Conclusions: Spacing exercise-based physical therapy sessions over 12 months using periodic booster sessions was less costly and more effective ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424013232

Osteoarthritis Year In Review 2024: Rehabilitation and ... An RCT in people with hand OA found that a home exercise program did not improve muscle strength, range of motion, pain, or function in 190 participants.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3302040/

Effectiveness of exercise for osteoarthritis of the knee Muscle strengthening and aerobic exercises are effective in reducing pain and improving physical function in patients with mild to moderate OA of the knee.

4. academic.oup.com academic.oup.com/ptj/article/98/1/16/4562625

Exercise, Manual Therapy, and Booster Sessions in Knee ... Spacing exercise-based physical therapy sessions over 12 months using periodic booster sessions was less costly and more effective over 2 years than strategies ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0222657

The Better Management of Patients with Osteoarthritis Program This was an observational registry-based study evaluating changes in outcome variables in patients following BOA program, including patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746515/

The osteoarthritis prevention study (TOPS) - PMC Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454192/

The Effect and Safety of App-Based Interventions for ... This study showed that app-based interventions were safe and effective for patients with OA, which might provide a cost-effective option, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424013207

Osteoarthritis year in review 2024: Epidemiology and therapy The global age-standardized rate of years lived with disability (YLDs) due to OA was 255.0 YLDs (95% UI 119.7–557.2) per 100,000 in 2020, marking a 9.5% (8.6– ...

9. bmj.com bmj.com/content/391/bmj-2025-085242

systematic review and network meta-analysis The safety outcome was reported in a small proportion of studies (40 studies, 18%), and no clear differences were observed between exercise ...

10. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00163-7/fulltext

Global, regional, and national burden of osteoarthritis ... Compared with 2020, cases of osteoarthritis are projected to increase 74·9% (59·4–89·9) for knee, 48·6% (35·9–67·1) for hand, 78·6% (57·7–105·3) for hip, and 95 ...