Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability

NCT04416243 | Completed

• 1 other identifier: 2018-19-24
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; adaptive equipment; rehabilitation; recumbent stepping; high-intensity interval training

Outcome Measures

Primary Outcomes (6)

• Recruitment, Retention, and Adherence Rates

  Participant recruitment, retention, and adherence rates will be recorded.

  From recruitment to end of treatment at 12 weeks.

• Time Needs

  Staff training, communication, recruitment, and intervention time will be recorded.

  From recruitment to end of treatment at 12 weeks.

• Monetary Needs

  Monetary research costs will be recorded.

  From recruitment to end of treatment at 12 weeks.

• Data Management and Safety Reporting

  Time from submission of Institutional Review Board application to approval will be recorded. All time spent collecting, entering, and checking data will be recorded.

  From recruitment to end of treatment at 12 weeks.

• Participant Burden Reporting

  Participants' experience, burden, and perceptions will be assessed via a short survey at the end of the 12 weeks.

  From recruitment to end of treatment at 12 weeks.

• Safety Reporting

  Adverse events, serious adverse events, and clinical emergencies will be recorded.

  From recruitment to end of treatment at 12 weeks.

Secondary Outcomes (8)

• Change in Aerobic Capacity

  Week 0, Following Week 6, Following Week 12

• Change in 6-Minute Walk Distance

  Week 0, Following Week 6, Following Week 12

• Change in 25-Foot Walk Speed

  Week 0, Following Week 6, Following Week 12

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

  Week 0, Following Week 6, Following Week 12

• Change in the Brief International Cognitive Assessment in MS Scores

  Week 0, Following Week 6, Following Week 12

Study Arms (1)

Recumbent Stepping, High-Intensity Interval Training

EXPERIMENTAL

Behavioral: Recumbent Stepping, High-Intensity Interval Training

Interventions

Recumbent Stepping, High-Intensity Interval Training BEHAVIORAL

The intervention will involve 12 weeks of supervised, progressive (i.e., intensity increases after midpoint testing based on reassessment of aerobic fitness) HIIT sessions two to three times per week. HIIT exercise sessions will be manualized and led by exercise leaders. Secondary outcomes testing will occur at baseline (week 0), midpoint (following week 6 of training), and post-intervention (following week 12 of training). The individual HIIT sessions will involve 10 cycles of 60s intervals at the wattage associated with 90% VO2peak followed by 60s of active recovery intervals at 15 watts, totaling 20 min in length. All exercise sessions will begin and end with a 5-minute warm-up and cool-down, respectively. Required power output for each interval of the exercise session will be individualized and completely automated. VO2peak from baseline and midpoint testing will be used to determine exercise intensity for weeks 1-6 and weeks 7-12, respectively.

Recumbent Stepping, High-Intensity Interval Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Texas, Denton, TX: lead
• University of Alabama at Birmingham: collaborator
• Berry College: collaborator

Study Sites (1)

University of North Texas

Denton, Texas, 76203, United States

Location

Related Publications (1)

• 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.

  PMID: 33239079 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephanie L Silveira, PhD

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 4, 2020
• Study Start: December 19, 2019
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

US (1)