A Single-group, Feasibility, and Initial Efficacy Study of a High-intensity Interval Training Program Using Adaptive Equipment in Persons With Multiple Sclerosis Who Have Walking Disability

CompletedNot a drug-phase studyMS (type not specified)NCT04416243

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Recumbent Stepping, High-Intensity Interval Training

What it measured

Main measures

  • Recruitment, Retention, and Adherence Rates

    From recruitment to end of treatment at 12 weeks.

    Quality of life (reported by participants)Feasibility
  • Time Needs

    From recruitment to end of treatment at 12 weeks.

  • Monetary Needs

    From recruitment to end of treatment at 12 weeks.

  • Data Management and Safety Reporting

    From recruitment to end of treatment at 12 weeks.

    Safety
  • Participant Burden Reporting

    From recruitment to end of treatment at 12 weeks.

  • Safety Reporting

    From recruitment to end of treatment at 12 weeks.

    Safety

Other measures (8)

  • Change in Aerobic Capacity

    Week 0, Following Week 6, Following Week 12

    Physical function
  • Change in 6-Minute Walk Distance

    Week 0, Following Week 6, Following Week 12

    Walking and mobility
  • Change in 25-Foot Walk Speed

    Week 0, Following Week 6, Following Week 12

    Walking and mobility
  • Change in Sedentary, Light, and Moderate-to-Vigorous Counts of Physical Activity

    Week 0, Following Week 6, Following Week 12

    Physical function
  • Change in the Brief International Cognitive Assessment in MS Scores

    Week 0, Following Week 6, Following Week 12

    Thinking and memory
  • Change in 9-Hole Peg Test Score

    Week 0, Following Week 6, Following Week 12

    Disability progression
  • Change in Fatigue Scores

    Week 0, Following Week 6, Following Week 12

    Fatigue
  • Change in Depressive Symptoms Scores

    Week 0, Following Week 6, Following Week 12

    Mood and sleep

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* age 18 or over * a self-reported diagnosis of multiple sclerosis * self-reported Expanded Disability Status Scale (EDSS) score \< 8.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 7.0 * relapse free in past 30 days * willing and able to visit Berry College or University of North Texas on three testing occasions and twenty four training occasions * asymptomatic status for maximal exercise testing; (g) physician approval for undertaking exercise testing * a self-reported ability to speak, read, and understand English

Exclusion criteria

* Any persons who do not meet the inclusion criteria

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

There is considerable evidence to support the efficacy of moderate intensity continuous (MIC) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking impairments (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 with recumbent arm/leg stepping (RSTEP). Of the published studies on HIIT in MS, HIIT yielded significant improvements in cardiorespiratory fitness in all but one study. In those studies that directly compared HIIT to MIC exercise, the data indicated a potential superiority of HIIT as compared to MIC in improving physiological conditioning in a time efficient manner. However, this evidence is specific to those with MS with mild to moderate disability engaging in cycle/arm ergometry and an investigation of HIIT in pwMS-wd is needed as the feasibility and potential benefits of engaging in HIIT in pwMS-wd is relatively unknown. The primary aim of the proposed study is to assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim is to examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms as clinically-relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention. It is hypothesized that the intervention will be feasible and lead to positive changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms. This work is informed by recently published data, which indicate that a single bout of RSTEP HIIT taxes the cardiorespiratory system significantly more than MIC exercise, yet without untoward effects on walking, gait, cognition, mood, or enjoyment. These data suggest that RSTEP HIIT may be an acceptable, safe, and tolerable stimulus for chronic exercise training.

Papers

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History

    1. Started

      Dec 2019

    2. Main results due

      Dec 2022

    3. Finished

      Dec 2022

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