Clinical trial NCT03963492: Intermittent vs Continuous Walking in People With Multiple Sclerosis
Official title: Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Walking
Gait
Fatigue
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Mount Sinai Rehabilitation Hospital
name: City University of New York, School of Public Health
First posted: 2019-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled pre-post study
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. Half of the participants will receive the continuous walking program while the other half will receive the novel intermittent walking program.

Detailed description: The typical rehabilitation of walking difficulties for people with MS has included practice walking. In general, this includes training to build walking endurance by having the person with MS walk until he/she becomes tired and needs to stop. Although this model has been used successfully to treat people with other diagnoses, it has limited effectiveness in improving walking ability and endurance in people with MS because of fatigue. Recently, a different model has been considered: intermittent or interval walking training. Interval walking training is organized such that seated rest breaks are intentionally interspersed between walking training bouts that end before the person with MS becomes too tired to continue. Exploratory research has shown that people with MS can walk faster and farther when using interval walking training, and may have more improvements in walking ability and endurance after using interval walking training. This study will compare the effectiveness of the traditional model of continuous walking training to the promising new model of interval walking training. This will help to determine whether interval or continuous walking training is superior in improving walking ability and endurance in people with MS.

Eligibility criteria: Inclusion Criteria:

* Self-identified difficulty walking
* Definitive diagnosis of multiple sclerosis from a neurologist
* Signed an approved consent form
* Ability to ambulate for unaided for 6-minutes continuously with or without an assistive device (e.g. a cane or brace)
* Has not had a multiple sclerosis relapse in the past 6 weeks

Exclusion Criteria:

* Unwilling or unable to complete assessments
* Unwilling or able to complete assessments and or intervention without the use of portable functional electrical stimulation devices
* Medical history of concomitant condition unrelated to multiple sclerosis which may impact results including: other neurological conditions including stroke, Parkinson's disease, or orthopedic, or cardiopulmonary conditions that affect walking
* Had a major change in exercise habits in the past three months
* Individuals reporting change in any disease modifying treatment or steroid use during the past 6 weeks
* Unable to walk for 6 minutes continuously without physical assistance
* Medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of deep vein thrombosis, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes
* Has an abnormal response to exercise
* Cannot adhere to protocol
* Determined to be unsafe at the discretion of the research team including individuals unwilling to wear safety "gait belt" during testing or not willing to wear proper footwear.

Primary outcomes:
measure: Change in 6-minute Walk Test distance
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary outcomes:
measure: Change in 12-item Multiple Sclerosis Walking Scale score
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
measure: Change in Fatigue Severity Scale score
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
measure: Change in Step Length
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
measure: Change in Step Time
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
measure: Change in Stride Velocity
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
measure: Change in Cadence
timeFrame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Evan T Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: