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临床试验/NCT05516537
NCT05516537已完成不适用

Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2022年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
2
主要终点
Walking Dysfunction

研究概览

简要总结

The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).

详细描述

There is a lack of evidence from high-quality randomized controlled trials (RCTs) of exercise training for African-Americans with multiple sclerosis (MS), as only 1.7% of participants in physical activity and exercise research involving persons with MS identify as African-American. The population of African-Americans with MS deserves equal and focal research that addresses the unique challenges of MS in the African-American rural residing community. We uniquely address this population with a highly-developed and refined exercise training program that is racially-tailored for the target population. We further provide a highly-developed and refined exercise training program that can be undertaken in one's home and/or local community, and does not require facility access that is extremely limited in the target, rural residing population of persons with MS. The program is further tailored based on qualitative research and addresses the unique needs of the African-American community with MS. There is no other research program this advanced in study refinement and design for immediate integration into a high-quality RCT for changing the lives of African-Americans with MS who reside in rural communities of the Southeastern portion of the United States. If successful, the study, as designed, will provide Class I evidence that is necessary for immediate implementation after trial completion through insurance providers and healthcare providers, including physical therapists, rehabilitation practitioners, and community health workers/providers. This program further aligns with recently developed and highly-refined conceptual and practice models for implementation of exercise into the care of persons with MS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English as primary language
  • Identify as African-American or Black
  • Age of 18 years or older
  • Diagnosis of MS
  • Relapse free in the past 30 days
  • Internet and email access
  • Willingness to complete the outcome questionnaires
  • Willingness to undergo randomization
  • Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ)
  • Mild-moderate ambulatory disability (MSWS-12 score between 25-49 & PDDS score between 2-4)

排除标准

  • Individuals not meeting above inclusion criteria
  • Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).

研究组 & 干预措施

Guidelines for Exercise in Multiple Sclerosis (GEMS)

Experimental

Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS).

干预措施: Guidelines for Exercise in Multiple Sclerosis (GEMS) (Behavioral)

FLEX Stretching and Toning Program

Sham Comparator

Participants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.

干预措施: FLEX Stretching and Toning Program (Behavioral)

结局指标

主要结局

Walking Dysfunction

时间窗: Changes in walking scores from Baseline, 4-months, and 8-months.

Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.

次要结局

  • Fatigue Severity(Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.)
  • Disability(Changes in disability scores from Baseline, 4-months, and 8 months.)
  • Depressive Symptoms(Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.)
  • Anxiety(Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.)
  • Health-related Quality of Life (HRQOL)(Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert W Motl

Robert W. Motl, PhD

University of Illinois at Chicago

研究点 (2)

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