Intermittent vs Continuous Walking in People With Multiple Sclerosis

Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness

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.

Study Overview

• Status: Suspended
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Walking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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.
Experimental: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute Walk Test distance	Is a measurement of the distance (in meters) walked at best pace in six minutes.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 12-item Multiple Sclerosis Walking Scale score	A survey that measures a participant's perception of how his/her walking ability is affected by multiple sclerosis. The scale ranges from 0-100 with lower scores representing a lesser impact of multiple sclerosis on the participant's walking ability. There are no subscales.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Fatigue Severity Scale score	A survey that measures a participant's perception of the impact of the symptom of fatigue on a person's ability to participate in life roles. The scale ranges from from 9-63, with lower scores representing a lower impact of fatigue on the ability to perform the activities listed in the scale.There are no subscales.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Length	The distance (in centimeters) traversed in one step from initial contact of one foot to the initial contact of the opposite foot.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Time	The time (in seconds) taken to complete one step from initial contact of one foot to the initial contact of the opposite foot.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Stride Velocity	The speed with which it takes a person to complete one stride from initial contact of one foot to the next initial contact of the same foot	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Cadence	The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Mount Sinai Rehabilitation Hospital; City University of New York, School of Public Health
• Investigators: Principal Investigator: Evan T Cohen, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Gait; Fatigue; Walking
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Pro2019000453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No