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

NCT ID: NCT04416243

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-12-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Recumbent Stepping, High-Intensity Interval Training

Group Type: EXPERIMENTAL

Recumbent Stepping, High-Intensity Interval Training

Intervention Type: 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.

Interventions

Recumbent Stepping, High-Intensity Interval Training

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Berry College

OTHER

Sponsor Role: collaborator

University of North Texas, Denton, TX

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Silveira

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie L Silveira, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Texas Health Science Center

Locations

University of North Texas

Denton, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33239079 (View on PubMed)

Other Identifiers

2018-19-24

Identifier Type: -

Identifier Source: org_study_id