Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial

Elizabeth A Hubbard, Robert W Motl, David J Elmer, Elizabeth A Hubbard, Robert W Motl, David J Elmer

Abstract

Background: There 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.

Methods: The 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.

Discussion: The 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 registration: ClinicalTrials.gov NCT04416243 . Retrospectively registered on June 4, 2020.

Keywords: Adaptive equipment; Exercise rehabilitation; Feasibility; High-intensity interval training; Intervention; Multiple sclerosis; Recumbent stepping; Rehabilitation.

Conflict of interest statement

The authors report no competing interests.

Figures

Fig. 1
Fig. 1
Diagram of recruitment through completion of the program. Note: MS=multiple sclerosis, T1=baseline assessment, T2=midpoint assessment, T3=post-intervention assessment, RSTEP=arm/leg recumbent stepping, HIIT=high-intensity interval training, VO2peak=peak oxygen consumption achieved at either the baseline or midpoint assessment
Fig. 2
Fig. 2
Schedule of enrollment, intervention, and assessments. Note: -T1=before baseline assessment, T1=baseline assessment, T2=midpoint assessment, T3=post-intervention assessment, MS=multiple sclerosis, RSTEP=arm/leg recumbent stepping, HIIT=high-intensity interval training
Fig. 3
Fig. 3
Exercise intervention progression schematics with acute exercise session protocols. Note: The figure is modified from Hubbard, Motl, and Fernhall [24]. T1=baseline assessment, T2=midpoint assessment, T3=post-intervention assessment, HIIT=high-intensity interval training, VO2peak=peak oxygen consumption achieved at either the baseline or midpoint assessment

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