一项涉及饮食、步行计划和呼吸锻炼的远程多模式干预对新诊断的多发性硬化症患者生活质量的影响：一项准实验性非劣效性试点研究。
Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.
作者信息
Saxby Solange M, Shemirani Farnoosh, Crippes Landon J, Ehlinger Mary A, Brooks Lisa, Bisht Babita, Titcomb Tyler J, Rubenstein Linda M, Eyck Patrick Ten, Hoth Karin F, Gill Christine, Kamholz John, Snetselaar Linda G, Wahls Terry L
机构信息
Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.
Department of Epidemiology, University of Iowa, Iowa City, IA, USA.
出版信息
Degener Neurol Neuromuscul Dis. 2024 Jan 9;14:1-14. doi: 10.2147/DNND.S441738. eCollection 2024.
BACKGROUND
Interventions involving diet, physical activity, and breathing exercises are shown to be beneficial in managing both fatigue and quality of life (QoL) related to MS; however, the impact of such interventions among people newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) who decline disease-modifying therapies (DMTs) is unknown.
METHODS
A 12-month prospective quasi-experimental non-inferiority trial recruited people newly diagnosed with CIS or RRMS who voluntarily declined DMTs (health behavior group; HB, n = 29) or followed standard of care (SOC, n = 15). Participants in the HB group were remotely coached on the study diet, moderate-intensity walking, and breathing exercises. All participants completed questionnaires validated to assess MS symptoms, including perceived mental and physical QoL (MSQOL54); fatigue (Fatigue Severity Scale, FSS; and Modified Fatigue Impact Scale, MFIS); mood (Hospital Anxiety and Depression Scale, HADS); and cognitive function (Perceived Deficits Questionnaire, PDQ).
RESULTS
During the 12 months, the HB group experienced improvement in scores for mental QoL (MSQOL54 - Mental, 0.24, 95% CI 0.01, 0.47; p = 0.04), fatigue (Total MFIS, -7.26, 95% CI -13.3,-1.18; p = 0.02), and perceived cognitive function (Total PDQ, PDQ-Attention, PDQ-Promemory, and PDQ-Planning, p ≤ 0.03 for all). A between-group difference was observed only for PDQ-Planning (p = 0.048). Non-inferiority analysis revealed that the 12-month changes in means for the HB group were not worse than those for the SOC group with respect to fatigue (FSS, p = 0.02), mood (HDS-Anxiety, p = 0.02; HADS-Depression, p < 0.0001), physical QoL (MSQOL54 - Physical, p = 0.02), or cognitive dysfunction (Total PDQ, p = 0.01).
CONCLUSION
The multimodal lifestyle intervention for individuals newly diagnosed with CIS or RRMS, who voluntarily decline DMTs, did not yield patient-reported outcomes worse than those observed in the SOC group regarding perceived mental quality of life, mood, fatigue, and cognitive function.
TRIAL REGISTRATION
clinicaltrials.gov identifier: NCT04009005.
背景
涉及饮食、体育活动和呼吸练习的干预措施已被证明对管理与多发性硬化症（MS）相关的疲劳和生活质量（QoL）有益；然而，对于新诊断为临床孤立综合征（CIS）或复发缓解型多发性硬化症（RRMS）且拒绝疾病修饰治疗（DMT）的患者，此类干预措施的影响尚不清楚。
方法
一项为期12个月的前瞻性准实验非劣效性试验招募了新诊断为CIS或RRMS且自愿拒绝DMT的患者（健康行为组；HB，n = 29）或遵循标准治疗（SOC，n = 15）。HB组的参与者接受了关于研究饮食、中等强度步行和呼吸练习的远程指导。所有参与者都完成了经过验证的问卷，以评估MS症状，包括感知的心理和身体生活质量（MSQOL54）；疲劳（疲劳严重程度量表，FSS；和改良疲劳影响量表，MFIS）；情绪（医院焦虑和抑郁量表，HADS）；以及认知功能（感知缺陷问卷，PDQ）。
结果
在12个月期间，HB组在心理生活质量（MSQOL54 - 心理，0.24，95% CI 0.01，0.47；p = 0.04）、疲劳（总MFIS，-7.26，95% CI -13.3，-1.18；p = 0.02）和感知认知功能（总PDQ、PDQ - 注意力、PDQ - 前瞻性记忆和PDQ - 计划，所有p≤0.03）方面的得分有所改善。仅在PDQ - 计划方面观察到组间差异（p = 0.048）。非劣效性分析显示，HB组在12个月内的均值变化在疲劳（FSS，p = 0.02）、情绪（HDS - 焦虑，p = 0.02；HADS - 抑郁，p < 0.0001）、身体生活质量（MSQOL54 - 身体，p = 0.02）或认知功能障碍（总PDQ，p = 0.01）方面不比SOC组差。
结论
对于新诊断为CIS或RRMS且自愿拒绝DMT的个体，多模式生活方式干预在患者报告的感知心理生活质量、情绪、疲劳和认知功能方面产生的结果并不比SOC组观察到的结果差。
试验注册
clinicaltrials.gov标识符：NCT04009005。
Zotero 插件