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7 results

  • Is there a threshold or dose-response association between physical activity and cognitive function in multiple sclerosis?

  • Brenda Jeng, Gary R. Cutter, Robert W. Motl
  • Journal:
    Journal of the International Neuropsychological Society , First View
    Published online by Cambridge University Press:
    24 March 2025, pp. 1-5
    • Article
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  • Objective:

    Cognitive impairment is prevalent, disabling, and poorly managed in multiple sclerosis (MS). Physical activity, often expressed as steps/day, has been associated with cognitive function in this population. This brief report examined the possibility of a (1) steps/day threshold associated with absence of cognitive impairment or (2) dose-response relationship between steps/day and cognitive function in MS.

    Method:

    The sample included 358 persons with MS who provided demographic (age, sex, race) and clinical (MS type, disease duration, disability status) information, and completed the Symbol Digit Modalities Test (SDMT) and California Verbal Learning Test-Second Edition (CVLT-II). Participants wore an ActiGraph GT3X+ accelerometer above the non-dominant hip during waking hours of the day over a 7-day period for measuring steps/day.

    Results:

    The receiver operating characteristic (ROC) curve analysis did not identify a steps/day threshold associated with cognitive impairment on SDMT (area under the curve [AUC] ranged between 0.606 and 0.691). The ROC curve analysis further did not identify a threshold of steps/day associated with cognitive impairment based on CVLT-II (AUC range 0.606 to 0.691). The regression analysis indicated significant linear relationships between steps/day and SDMT (R2 = .06; β=.251; p < .001) and CVLT-II (R2 = .06; β=.247; p < .001) z-scores.

    Conclusion:

    The observed linear relationship suggests that focusing on increasing steps/day across all levels of physical activity might have benefits for cognitive function in MS.

  • 23 - Multiple Sclerosis

  • from Section 6
  • Edited by Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole
  • Book:
    Clinical Trials in Neurology
    Published online:
    05 May 2012
    Print publication:
    12 April 2012, pp 257-272

  • Summary

    Special trial designs have been developed to distinguish the symptomatic and disease modifying effects of treatment using clinical outcome measures. These designs, termed 'two-period' designs, include the so-called withdrawal and delayed-start (or 'staggered-start') designs and their variations. This chapter describes these study designs in terms of their rationale, assumptions, design features, implementation, statistical analysis, and sample size considerations. It also discusses the important limitations of the designs. Simulation studies using disease progression modeling suggest that the withdrawal design may provide more power than the delayed start design to detect disease-modifying effects of a treatment. A statistical model for data from a complete two-period design assumes that a normally-distributed outcome termed µ 2. There are alternative approaches to evaluating the disease-modifying effects of an intervention that require only a single treatment period.

  • 6 - Measures of neurological impairment and disability in multiple sclerosis

  • from Section II - Clinical trial methodology
  • Edited by Jeffrey A. Cohen, Richard A. Rudick
  • Book:
    Multiple Sclerosis Therapeutics
    Published online:
    05 December 2011
    Print publication:
    20 October 2011, pp 56-64

  • Summary

    This chapter deals with the measurement of impairment or disability for use in multiple sclerosis (MS) clinical trials from a medical model perspective, focusing on global clinical trial outcome measures. It addresses the methodological issues in measuring impairment and disability. The measures of neurological impairment and disability in MS can be grouped into four classes: biological assays, performance measures, rating scales and self-report measures. The Incapacity Status Scale and the multiple sclerosis (MS) Quality of Life Inventory are examples of such self-report measures, also called patient reported outcomes or PROs. Surrogate outcome measures have been studied in a variety of diseases and have been hoped for within the MS community. The development of the Multiple Sclerosis Functional Composite (MSFC) resulted from the analysis of a pooled data set of placebo control groups and natural history study databases.