一项为期4个月的平行组随机对照试验的原理，该试验旨在评估针对患有多发性硬化症的西班牙裔/拉丁裔人群的远程运动训练干预措施（FERLA MS）的可行性和有效性。
Rationale for a 4-month, parallel-group, randomized controlled trial to assess the Feasibility and Efficacy of a Remotely delivered exercise training intervention for Hispanics/Latinos with Multiple Sclerosis (FERLA MS).
作者信息
Flores Victoria A, Silveira Stephanie L, Marquez David X, Kinnett-Hopkins Dominique, Miravalle Augusto, Sierra-Morales Fabian, Hernández-Peraza Zulma, Motl Robert W
机构信息
Department of Kinesiology and Nutrition, University of Illinois Chicago, Chicago, IL, USA.
Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.
出版信息
Pilot Feasibility Stud. 2025 May 8;11(1):62. doi: 10.1186/s40814-025-01641-5.
BACKGROUND
Hispanic/Latino individuals with multiple sclerosis (MS) face greater disease burden and comorbidity due to limited healthcare access, underrepresentation in research, and social determinants of health (SDOH). Exercise training could manage health outcomes, but existing intervention research lacks Hispanic/Latino representation.
METHODS
We propose a feasibility and efficacy study of a theory-based, remotely delivered exercise training intervention for enhancing health outcomes in Hispanics/Latinos with MS. This study involves a randomized controlled trial (RCT) design and compares an MS-specific exercise training program with an active control condition over a 4-month period in a sample of 50 individuals who self-identified as Hispanic/Latino with MS. The sample will be recruited through MS networks and healthcare organizations serving a high proportion of Hispanics/Latinos with MS. The primary outcomes include feasibility metrics (i.e., process, resources, management, and scientific), secondary outcomes include potential effects of the exercise training program on health-related outcomes (i.e., physical and cognitive function, MS symptoms, and quality of life), and tertiary outcomes include the potential association of SDOH on feasibility and intervention efficacy on health-related outcomes.
DISCUSSION
The anticipated results of this study will provide evidence for the feasibility and initial efficacy of a remote exercise training intervention for Hispanics/Latinos with MS, a demographic often facing significant barriers to healthcare and rehabilitation. This research lays the groundwork for a fully powered RCT to support the efficacy of the approach and subsequent wider implementation. If successful, this project may significantly improve health and MS disease outcomes for Hispanics/Latinos with MS.
PROTOCOL VERSION
April 7, 2025, Version 2; World Health Organization Trial Registration Data Set (see Appendix 1); SPIRIT Checklist (see Appendix 2).
TRIAL REGISTRATION
ClinicalTrials.gov (NCT05998616).
背景
患有多发性硬化症（MS）的西班牙裔/拉丁裔个体由于医疗保健机会有限、在研究中的代表性不足以及健康的社会决定因素（SDOH），面临着更大的疾病负担和合并症。运动训练可以改善健康状况，但现有的干预研究缺乏西班牙裔/拉丁裔的参与。
方法
我们提出一项基于理论的、远程提供的运动训练干预的可行性和有效性研究，以改善患有MS的西班牙裔/拉丁裔个体的健康状况。本研究采用随机对照试验（RCT）设计，在50名自我认定为患有MS的西班牙裔/拉丁裔个体的样本中，将特定于MS的运动训练计划与积极对照条件在4个月的时间内进行比较。样本将通过MS网络和为大量患有MS的西班牙裔/拉丁裔提供服务的医疗保健组织招募。主要结果包括可行性指标（即过程、资源、管理和科学性），次要结果包括运动训练计划对健康相关结果（即身体和认知功能、MS症状和生活质量）的潜在影响，第三结果包括SDOH对可行性的潜在关联以及对健康相关结果的干预效果。
讨论
本研究的预期结果将为针对患有MS的西班牙裔/拉丁裔的远程运动训练干预的可行性和初步有效性提供证据，这一人群在医疗保健和康复方面往往面临重大障碍。这项研究为一项全面的RCT奠定了基础，以支持该方法的有效性及随后更广泛的实施。如果成功，该项目可能会显著改善患有MS的西班牙裔/拉丁裔的健康和MS疾病结局。
方案版本
2025年4月7日，第2版；世界卫生组织试验注册数据集（见附录1）；SPIRIT清单（见附录2）。
试验注册
ClinicalTrials.gov（NCT05998616）。
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