Contributions
Abstract: P377
Type: Poster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Introduction: More granular disability metrics are needed to advance research in multiple sclerosis (MS), particularly for clinical trials in progressive MS. The Expanded Disability Status scale (EDSS), the most frequently used disability metric in MS, fails to capture important variability in walking behaviour within categorical ambulatory disability levels that can affect function and influence health. STEPS (average daily step count) measured using remote accelerometry provides granular, continuous information about physical activity in real-world settings.
Objective: To measure change in STEPS captured remotely over 1 year in people with MS using a commercially-available wrist-worn accelerometer (Fitbit Flex).
Methods: Adults with MS (relapsing or progressive) able to walk at least 2 minutes were prospectively recruited into the UCSF FITriMS cohort. Physical activity was recorded continuously using a Fitbit Flex over 1 year and data collected using the UCSF Health eHeart research platform. Performance-based measures (e.g. EDSS, Timed-25-foot-walk; T25FW) were evaluated at baseline and 1-year, and patient-reported outcomes (e.g. 12-item MS-walking-scale; MSWS-12) were completed at baseline, 1.5, 3, 6, 9 and 12-months. Univariate and multivariable analyses were performed.
Results: Of 100 participants (61 relapsing MS, 39 progressive MS), 69 have completed 1-year follow-up and 11 more are scheduled (anticipated retention 80%); 14 withdrew, and 6 were lost to follow-up. Over 1 year, for the entire cohort, STEPS decreased 10.7% (mean decrease: 1236 steps/day, SD: 3065), and 53.4% decreased STEPS more than 800 steps/day (a threshold that has been proposed as a Minimal Clinically Important Difference for physical activity). Average STEPS in people with progressive MS declined less (0.2% decline from baseline, mean: -903, SD: 2239) than in those with relapsing MS (16.5% decline from baseline, mean: -1413, SD: 3436). There was wide variability in STEPS change over 1 year, including in people whose EDSS remained unchanged (for example, for people who remained EDSS 6.0 change in STEPS ranged from +814 to -3718).
Discussion: Longitudinal measurement of STEPS using a commercially-available activity monitor is feasible with high retention and reveals changes in daily function not otherwise captured by more traditional disability metrics.
Disclosure:
V. J. Block: nothing to disclose
R. Bove: Has received funding from the NMSS
A. Keshavan: nothing to disclose
C. Zhao: nothing to disclose
C. J. Bevan: nothing to disclose
E. Crabtree-Hartman: has received educational grants from the MS Foundation, Teva neurosciences, and Biogen. She has served as a consultant to Genzyme, Teva and Novartis. She is on the Speakers Bureau for Genzyme, Teva and Biogen
J. S. Graves: has current research grants from Race to Erase MS, National MS Society, Genentech, and Biogen.
A. J. Green: has received research grants from the NMSS, NIH, Novartis and Inception 5 Sciences. He has served on an end point adjudication committee for Mediimmune and a steering committee for OCTIMs. He has served as an expert witness for Mylan and Amneal. He also is on the Scientific Advisory Board of Bionure and Inception Sciences.
P. Garcha: nothing to disclose
P-A. Gourraud: nothing to disclose
J. Pletcher: nothing to disclose
J. E. Olgin: nothing to disclose
G. M. Marcus: nothing to disclose
D. D. Allen: has received compensation as an instructor for the Neurologic Physical Therapy Residency Program at Kaiser Redwood City.
B. A. C. Cree: has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, MedImmune, Novartis, Genzyme/sanofi aventis, Teva and has received contracted research support (including clinical trials) from Acorda, Biogen, EMD Serono, Hoffman La Roche, MedImmune, Novartis and Teva.
J. M. Gelfand: has served as a consultant on a scientific advisory board for MedImmune and Hoffman La Roche; has received research support from Quest Diagnostics through UCSF on a dementia care pathway; and has received compensation for medical legal consulting related to CNS inflammatory disorders.
Abstract: P377
Type: Poster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Introduction: More granular disability metrics are needed to advance research in multiple sclerosis (MS), particularly for clinical trials in progressive MS. The Expanded Disability Status scale (EDSS), the most frequently used disability metric in MS, fails to capture important variability in walking behaviour within categorical ambulatory disability levels that can affect function and influence health. STEPS (average daily step count) measured using remote accelerometry provides granular, continuous information about physical activity in real-world settings.
Objective: To measure change in STEPS captured remotely over 1 year in people with MS using a commercially-available wrist-worn accelerometer (Fitbit Flex).
Methods: Adults with MS (relapsing or progressive) able to walk at least 2 minutes were prospectively recruited into the UCSF FITriMS cohort. Physical activity was recorded continuously using a Fitbit Flex over 1 year and data collected using the UCSF Health eHeart research platform. Performance-based measures (e.g. EDSS, Timed-25-foot-walk; T25FW) were evaluated at baseline and 1-year, and patient-reported outcomes (e.g. 12-item MS-walking-scale; MSWS-12) were completed at baseline, 1.5, 3, 6, 9 and 12-months. Univariate and multivariable analyses were performed.
Results: Of 100 participants (61 relapsing MS, 39 progressive MS), 69 have completed 1-year follow-up and 11 more are scheduled (anticipated retention 80%); 14 withdrew, and 6 were lost to follow-up. Over 1 year, for the entire cohort, STEPS decreased 10.7% (mean decrease: 1236 steps/day, SD: 3065), and 53.4% decreased STEPS more than 800 steps/day (a threshold that has been proposed as a Minimal Clinically Important Difference for physical activity). Average STEPS in people with progressive MS declined less (0.2% decline from baseline, mean: -903, SD: 2239) than in those with relapsing MS (16.5% decline from baseline, mean: -1413, SD: 3436). There was wide variability in STEPS change over 1 year, including in people whose EDSS remained unchanged (for example, for people who remained EDSS 6.0 change in STEPS ranged from +814 to -3718).
Discussion: Longitudinal measurement of STEPS using a commercially-available activity monitor is feasible with high retention and reveals changes in daily function not otherwise captured by more traditional disability metrics.
Disclosure:
V. J. Block: nothing to disclose
R. Bove: Has received funding from the NMSS
A. Keshavan: nothing to disclose
C. Zhao: nothing to disclose
C. J. Bevan: nothing to disclose
E. Crabtree-Hartman: has received educational grants from the MS Foundation, Teva neurosciences, and Biogen. She has served as a consultant to Genzyme, Teva and Novartis. She is on the Speakers Bureau for Genzyme, Teva and Biogen
J. S. Graves: has current research grants from Race to Erase MS, National MS Society, Genentech, and Biogen.
A. J. Green: has received research grants from the NMSS, NIH, Novartis and Inception 5 Sciences. He has served on an end point adjudication committee for Mediimmune and a steering committee for OCTIMs. He has served as an expert witness for Mylan and Amneal. He also is on the Scientific Advisory Board of Bionure and Inception Sciences.
P. Garcha: nothing to disclose
P-A. Gourraud: nothing to disclose
J. Pletcher: nothing to disclose
J. E. Olgin: nothing to disclose
G. M. Marcus: nothing to disclose
D. D. Allen: has received compensation as an instructor for the Neurologic Physical Therapy Residency Program at Kaiser Redwood City.
B. A. C. Cree: has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, MedImmune, Novartis, Genzyme/sanofi aventis, Teva and has received contracted research support (including clinical trials) from Acorda, Biogen, EMD Serono, Hoffman La Roche, MedImmune, Novartis and Teva.
J. M. Gelfand: has served as a consultant on a scientific advisory board for MedImmune and Hoffman La Roche; has received research support from Quest Diagnostics through UCSF on a dementia care pathway; and has received compensation for medical legal consulting related to CNS inflammatory disorders.