Victoria A Flores, Stephanie L Silveira, David X Marquez, Dominique Kinnett-Hopkins, Augusto Miravalle, Fabian Sierra-Morales, Zulma Hernández-Peraza, Robert W Motl
{"title":"一项为期4个月，平行组，随机对照试验的基本原理，以评估远程交付运动训练干预西班牙/拉丁裔多发性硬化症（FERLA MS）的可行性和有效性。","authors":"Victoria A Flores, Stephanie L Silveira, David X Marquez, Dominique Kinnett-Hopkins, Augusto Miravalle, Fabian Sierra-Morales, Zulma Hernández-Peraza, Robert W Motl","doi":"10.1186/s40814-025-01641-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Protocol version: </strong>April 7, 2025, Version 2; World Health Organization Trial Registration Data Set (see Appendix 1); SPIRIT Checklist (see Appendix 2).</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT05998616).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"62"},"PeriodicalIF":1.5000,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060554/pdf/","citationCount":"0","resultStr":"{\"title\":\"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).\",\"authors\":\"Victoria A Flores, Stephanie L Silveira, David X Marquez, Dominique Kinnett-Hopkins, Augusto Miravalle, Fabian Sierra-Morales, Zulma Hernández-Peraza, Robert W Motl\",\"doi\":\"10.1186/s40814-025-01641-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Protocol version: </strong>April 7, 2025, Version 2; World Health Organization Trial Registration Data Set (see Appendix 1); SPIRIT Checklist (see Appendix 2).</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT05998616).</p>\",\"PeriodicalId\":20176,\"journal\":{\"name\":\"Pilot and Feasibility Studies\",\"volume\":\"11 1\",\"pages\":\"62\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-05-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060554/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pilot and Feasibility Studies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40814-025-01641-5\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01641-5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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).
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).
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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