Osher Directors, Drs. Peter Wayne and Gloria Yeh secured multiple R01 grant funding from the National Institutes of Health to support multi-site research studies in chiropractic care for migraines, fall prediction in older adults and web-based technology interventions to support physical activity in populations impacted by chronic diseases.
Chiropractic Care for Episodic Migraine
R01 AT012228 (2023 – 2025)
Multiple PI: Peter M. Wayne, PhD
Multiple PI: Pamela Rist, ScD
Multiple PI: Jason Sico, MD (Yale University and Connecticut VA)
Osher Clinical Team members: Carolyn Bernstein, MD, Meredith Beaton-Starr
This multi-site study is being conducted in partnership with the Veterans Administration and Yale University.
Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints.
We recently completed a pilot single-site multimodal randomized clinical trial among 61 adult women with episodic migraine evaluating chiropractic care (CC) (10 visits over 14 weeks) and enhanced usual care (EUC) versus EUC alone on migraine frequency, severity, duration, and medication use. Recruitment, retention, and adherence to our study protocols were demonstrated to be feasible and preliminary clinical outcomes were promising. Our goal is to conduct a multi-site large-scale fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability.
This study will address the following aims:
1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess fidelity of intervention protocols;
2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial;
3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites;
4) To assess participant expectations and treatment experience.
Using Instrumented Everyday Gait to Predict Falls in Older Adults Using the Women’s Health Study Cohort
R01 AG078256-01 (2023-2026)
Multiple PI: Peter M. Wayne, PhD
Multiple PIs: I Min Lee, ScD (Brigham and Women’s Hospital; Jeffery Hausdorff, PhD (Tel Aviv Sourasky Medical Center)
This multi-site study is being conducted in partnership with the Tel Aviv Sourasky Medical Center and Marcus Institute for Aging Research, Hebrew Senior Life
Among community-living older adults, falls are a leading cause of injury, disability, injury-related death, and high medical costs. Despite decades of research, the proportion of older adults who fall has not declined. Identifying older adults at risk of falls remains a major public health priority. Exercise and other interventions can lower fall risk; however, new tools are needed to determine who is most likely to benefit from early interventions. Early research linking fall risk to gait measures obtained in the clinic (e.g., average speed, stride variability) contributed significantly to the understanding of the prediction of fall risk.
Studies have also shown that older adults who are more active have reduced risks of falls and fall-related injury. However, critical gaps remain. Exciting advances in digital medicine and remote monitoring using wearable devices have afforded new and more widely accessible opportunities for evaluating the relationships between Daily Living Gait (DLG) and Daily Living Physical Activity (DLPA) to injurious falls in older adults. Measures of DLG (e.g., gait speed, cadence, variability, and how these vary throughout the week) and measures of DLPA (e.g., activity levels and activity fragmentation) can all be derived from a single accelerometer worn for 1 week. While growing evidence suggests that DLG and DLPA do a better job at predicting falls than conventional in-clinic measures, studies to date have been relatively small and have not focused on the prediction of injurious falls. Moreover, little is known about the utility of combining DLG and DLPA measures to predict injurious falls.
To address these gaps, this study will leverage:
1) an existing large dataset of older women enrolled in the Women’s Health Study (WHS) and
2) advances in wearable technology and machine learning.
From 2011 to 2015, 17,466 WHS women wore a tri-axial accelerometer during waking hours for a week; they also regularly self-reported their physical activity levels and health history.
This study, for the first time, will evaluate, if and how DLG and DLPA measures predict fall-related injuries in this aging cohort (average age=72 years at the time of accelerometer wear) using records of injurious falls from the Centers for Medicare & Medicaid Services (CMS).
We will also determine if self-reported exercise history is associated with DLG and DLPA, and explore whether markers of DLG and DLPA are associated with risks of injurious falls over more extended periods of 5 and 10 years, as secondary and exploratory aims. By taking advantage of a unique, large dataset, our multi-disciplinary team will identify potential “signatures” to identify high-risk adults who may benefit from early fall prevention strategies and markedly accelerate the potential of using digital markers of fall risk.
Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in ACS Survivors
R01 AT012072-01 (2023-2026)
Multiple PI: Gloria Y. Yeh, MD, MPH
Multiple PI: Elena Salmoirago-Blotcher, MD (Brown University/Miriam Hospital)
This multi-site feasibility study is being conducted in partnership with Brown University and Miriam Hospital.
Physical activity (PA) is a cornerstone of secondary prevention after an acute coronary syndrome (ACS) with associated improvements in cardiovascular risk, morbidity, and mortality. Unfortunately, over 80% of these cardiovascular patients remain sedentary after an event. Participation in cardiac rehabilitation programs is poor, and long-term adherence to PA remains problematic. There is a critical need for the development of novel exercise programs to improve PA in this high-risk patient population.
Tai Chi (TC) is a multi-dimensional intervention that integrates low-moderate intensity physical exercise with meditative components that have been shown to improve important self-regulatory skills and cognitive-behavioral determinants of behavior change, such as self-efficacy, motivation, and emotional health. Because it is delivered in a class format, TC also fosters social support. Preliminary evidence suggests that TC may positively impact PA and selected cardiovascular risk factors. TC is an attractive exercise option for ACS survivors, who are often sedentary or deconditioned. There is also growing evidence supporting the use of wearable technology (e.g., Fitbit) as an effective behavioral strategy to promote PA. Wearable devices can utilize evidence-based techniques such as individualized goal setting and feedback in increasing motivation and self-efficacy for exercise. In patients with cardiometabolic disease, the addition of wearable technology to structured exercise has been promising to increase moderate-vigorous PA and improve cardiovascular risk.
This study leverages prior work with TC to promote PA among sedentary ACS survivors, experience with remote delivery of group-based TC, and experience combining mind-body exercise with wearables (Fitbit).
This multi-site feasibility study will investigate the efficacy of a multi-modal intervention (TC+Wearable) that combines virtual, group TC classes with an individual wearable device (Fitbit) to support overall PA, and thus impact downstream cardiometabolic risk.
The specific aims are:
1) To assess feasibility of a multi-site randomized controlled trial of TC+Wearable plus enhanced usual care (with cardiovascular risk factor education materials) vs. enhanced usual care alone among inactive ACS survivors.
2) To obtain qualitative feedback from multiple stakeholders to inform future study conduct. We will engage patients, providers, and TC instructors in interviews/focus groups on acceptability of TC+Wearable (content, facilitators/barriers, integration of TC and device); technical aspects of remote delivery; and openness for future provider and TC instructor engagement.
Mindful Steps: A Web-Based Mind-Body Exercise Intervention to Promote Physical Activity in Chronic Cardiopulmonary Disease
R01 AT012166-01A1 (2023-2028)
PI: Gloria Y. Yeh, MD, MPH
This is a fully remote efficacy study with nationwide recruitment being conducted in partnership with the Veterans Administration and Michigan University.
Physical activity (PA) is an important modifiable behavior that has enormous impacts on chronic cardiopulmonary health. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are similar systemic syndromes where patients are often deconditioned and suffer exercise intolerance and dyspnea. Importantly, these patients share a dramatically high risk of sedentary behavior that portend poor outcomes. While PA is paramount in disease management (with improvements in exercise capacity, quality-of-life, and hospitalizations) available exercise programs are underutilized and inaccessible, and long-term adherence to PA is universally problematic. Novel strategies to increase PA in these populations are greatly needed.
In a previously funded NIH developmental grant (R34AT009354) we leveraged our experience in web-based PA interventions together with our expertise in mind-body therapies to develop a novel multi-modal intervention (Mindful Steps) for patients with COPD and HF to foster longer-term PA adherence. Our theoretical model posits that the integration of a mind-body curriculum enhances key behavioral constructs in the existing intervention and also targets new areas that will lead to enhanced self-efficacy and increased, sustained PA. In a pilot study, we have demonstrated study feasibility (recruitment, retention, all-remote data collection), and intervention feasibility/acceptability (including online, synchronous mind-body classes).
This study will test the efficacy of Mindful Steps, compared to usual care, to promote PA (objectively measured by daily step counts) in patients with COPD and/or HF. Secondary aims will examine cognitive-behavioral measures within our theoretical model (self-efficacy for exercise and for disease management, intrinsic motivation, mindfulness, interoceptive awareness) and patient-centered clinical outcomes (disease-specific quality of life, exercise engagement, dyspnea, fatigue).