Intermittent vs Continuous Walking in People With Multiple Sclerosis

NCT ID: NCT03963492

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Walking

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

Group Type: ACTIVE_COMPARATOR

Walking

Intervention Type: OTHER

Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.

Interval Walking

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

Group Type: EXPERIMENTAL

Walking

Intervention Type: OTHER

Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.

Interventions

Walking

Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

City University of New York, School of Public Health

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Evan T. Cohen, SHRP Department of Rehabilitation and Movemen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan T Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

Pro2019000453

Identifier Type: -

Identifier Source: org_study_id