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NCT04416243 · ClinicalTrials.gov registry record · NA
Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability
A NA study, sponsored by University of North Texas, Denton, TX.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04416243 is a NA study that has completed, run by University of North Texas, Denton, TX. The registered enrollment target is 17 participants.
The verdict
NCT04416243, a NA study, has completed, sponsored by University of North Texas, Denton, TX.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Recumbent Stepping, High-Intensity Interval Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2022-12-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04416243
The ClinicalTrials.gov registry entry for NCT04416243 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Texas, Denton, TX, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Recumbent Stepping, High-Intensity Interval Training is the first listed.
NCT04416243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04416243 about?
NCT04416243 is a clinical study titled "Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability". 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...
What is the current status of trial NCT04416243?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2019-12-19. Estimated completion is 2022-12-14.
What interventions are being tested in trial NCT04416243?
The interventions under investigation include: Recumbent Stepping, High-Intensity Interval Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04416243?
This trial is sponsored by University of North Texas, Denton, TX, which has 8 total clinical trials registered on ClinicalTrials.gov.
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