Clinical trial NCT04416243: Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
adaptive equipment
rehabilitation
recumbent stepping
high-intensity interval training
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Berry College
First posted: 2020-06-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Recruitment, Retention, and Adherence Rates
timeFrame: From recruitment to end of treatment at 12 weeks.
measure: Time Needs
timeFrame: From recruitment to end of treatment at 12 weeks.
measure: Monetary Needs
timeFrame: From recruitment to end of treatment at 12 weeks.
measure: Data Management and Safety Reporting
timeFrame: From recruitment to end of treatment at 12 weeks.
measure: Participant Burden Reporting
timeFrame: From recruitment to end of treatment at 12 weeks.
measure: Safety Reporting
timeFrame: From recruitment to end of treatment at 12 weeks.
Secondary outcomes:
measure: Change in Aerobic Capacity
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in 6-Minute Walk Distance
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in 25-Foot Walk Speed
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in Sedentary, Light, and Moderate-to-Vigorous Counts of Physical Activity
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in the Brief International Cognitive Assessment in MS Scores
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in 9-Hole Peg Test Score
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in Fatigue Scores
timeFrame: Week 0, Following Week 6, Following Week 12
measure: Change in Depressive Symptoms Scores
timeFrame: Week 0, Following Week 6, Following Week 12
Other outcomes:
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Stephanie L Silveira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubbard EA, Motl RW, Elmer DJ. 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. Trials. 2020 Nov 25;21(1):972. doi: 10.1186/s13063-020-04887-x.