Abstract
BackgroundThere is considerable evidence for the efficacy of moderate-intensity continuous exercise benefitting clinically relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking disability (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (HIIT), especially while utilizing adaptive equipment, such as recumbent arm/leg stepping (RSTEP). The proposed study will assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim will examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depression as clinically relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention.MethodsThe study will recruit 15 pwMS-wd. Feasibility will be measured via process, resource, management, and scientific outcomes throughout the entirety of the research study. The secondary, clinically relevant outcomes will consist of a neurological exam, aerobic capacity, physical activity, ambulation, cognition, upper arm function, fatigue, and depression. Outcomes will be assessed at baseline (T1), midpoint (T2, following 6 weeks), and post-intervention (T3, following 12 weeks). The intervention will involve 12 weeks of supervised, individualized HIIT sessions two to three times per week. The individual HIIT sessions will each involve 10 cycles of 60-s intervals at the wattage associated with 90% VO2peak followed by 60 s of active recovery intervals at 15 W, totaling 20 min in length plus 5-min warm-up and cool-down periods.DiscussionThe feasibility design of the proposed study will provide experience and preliminary data for advancing towards a proof-of-concept study comparing HIIT to moderate-intensity continuous RSTEP for improving clinically relevant outcomes in a randomized control trial design. The results will be disseminated via manuscripts for publication and a report for distribution among the National Multiple Sclerosis Society.Trial registrationClinicalTrials.gov NCT04416243. Retrospectively registered on June 4, 2020
Highlights
There is considerable evidence for the efficacy of moderate-intensity continuous exercise benefitting clinically relevant outcomes in persons with multiple sclerosis (MS)
This evidence is specific among those with MS who have low disability engaging in cycle/arm ergometry, and the authors concluded that an investigation of high-intensity interval training (HIIT) in persons with MS who have walking disability (pwMS-wd) is necessary as the feasibility and potential benefits are relatively unknown
No control group will be used because we aim to identify the feasibility and preliminary efficacy of the HIIT exercise protocol alone in pwMS-wd [38]
Summary
Recruitment The study will recruit 15 pwMS-wd (i.e., a PDDS score of 3–6) from areas surrounding Berry College. Eligibility criteria, and retention Inclusion criteria Participants who meet the following criteria will be included: (a) age 18–64 years, (b) a self-reported diagnosis of MS, (c) self-reported Expanded Disability Status Scale (EDSS) score < 8.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 7.0, (d) relapse free in past 30 days, (e) willing and able to visit Berry College on three testing occasions and twenty-four training occasions, (f) asymptomatic status for maximal exercise testing, (g) physician approval for undertaking exercise testing, and (h) a self-reported. The resource feasibility outcomes will evaluate any research-stage-dependent time and resource issues that can occur and provide expected retention rates, barriers to participation, compliance rates, participant experience of the program and outcome assessments, suitability of the proposed setting, staff training needs, and monetary costs to conduct the research and establish areas for cost saving.
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