Intermittent vs Continuous Walking in People With Multiple Sclerosis

Rutgers The State University of New Jersey

Status: Suspended

Conditions: Multiple Sclerosis

Treatments: Other: Walking

Study type: Interventional

Funder types: Other

Identifiers

NCT03963492

Pro2019000453

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Continuous Walking

Active Comparator group

Description:

Participants in the Continuous Walking (CONT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the CONT group will be to complete a 6-minute long walk without rest breaks

Treatment:

Other: Walking

Interval Walking

Experimental group

Description:

Participants in the Interval Walking (INT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the (INT) group will be to complete three 2-minute-long walks with 2-minute seated rest breaks between each walk

Treatment:

Other: Walking