Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability
NCT04416243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2023-04-19
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
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
University of Alabama at Birmingham
collaborator OTHER -
Berry College
collaborator OTHER -
University of North Texas, Denton, TX
lead OTHER
Principal Investigators
-
Stephanie L Silveira, PhD · University of North Texas Health Science Center
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-19
- Primary Completion
- 2022-12-14
- Completion
- 2022-12-14
Countries
- United States
Study Locations
More Related Trials
-
Early Exercise Efforts in Multiple Sclerosis
NCT03322761 ·Status: COMPLETED ·Phase: NA
-
E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity
NCT06298201 ·Status: RECRUITING ·Phase: NA
-
Promoting Physical Activity for Persons With Multiple Sclerosis
NCT00513448 ·Status: COMPLETED ·Phase: NA
-
Physiotherapist-guided Home Exercise in Moderate to Severe MS
NCT03039400 ·Status: COMPLETED ·Phase: NA
-
Endurance and Walking Training by Nordic Walking in Multiple Sclerosis
NCT03976128 ·Status: COMPLETED ·Phase: NA
-
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
NCT06355804 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Effectiveness of Task Specific Home Exercise Program
NCT06486116 ·Status: RECRUITING ·Phase: NA
-
Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
NCT03136744 ·Status: COMPLETED ·Phase: NA
-
Step it Up: An Exercise and Behaviour Change Programme for People With Multiple Sclerosis
NCT02301442 ·Status: COMPLETED ·Phase: NA
-
Multiple Sclerosis and Respiratory and Functional Capacity
NCT05697523 ·Status: COMPLETED
-
Role of Individualized Versus Traditional Exercise in Combating Fatigue
NCT04796272 ·Status: TERMINATED ·Phase: NA
-
Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
NCT05057338 ·Status: UNKNOWN ·Phase: NA
-
Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
NCT03944538 ·Status: TERMINATED ·Phase: NA
-
Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI
NCT00947232 ·Status: COMPLETED ·Phase: NA
-
Implementing Physical Activity Guidelines for Adults With MS
NCT02100020 ·Status: COMPLETED ·Phase: NA
-
Scale Up Evaluation of a Physical Activity Program for Adults With Physical Disability
NCT03024320 ·Status: COMPLETED ·Phase: NA
-
Stepping Up to Health: Feedback to Promote Physical Activity in Diabetes
NCT00151021 ·Status: COMPLETED ·Phase: NA
-
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
NCT02008071 ·Status: COMPLETED ·Phase: NA
-
Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)
NCT06884579 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis
NCT05752630 ·Status: UNKNOWN
-
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
NCT05740839 ·Status: RECRUITING ·Phase: NA
-
Classroom Break, Cognition, and Fitness in Elementary School Children
NCT06258941 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)
NCT06925022 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Walking Intervention Through Text Messaging
NCT02053259 ·Status: COMPLETED ·Phase: NA
-
Efficacy of a Tailored Communication Intervention Aimed At Increasing the Number of Daily Steps
NCT05620888 ·Status: RECRUITING ·Phase: NA