Intermittent vs Continuous Walking in People With Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT03963492
• Recruitment Status: Suspended
• First Posted: May 24, 2019
• Last Update Posted: September 16, 2021
• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Mount Sinai Rehabilitation Hospital; City University of New York, School of Public Health
• Information provided by (Responsible Party): Evan T. Cohen, SHRP Department of Rehabilitation and Movemen, Rutgers, The State University of New Jersey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Other: Walking	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled pre-post study
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessors blinded to experimental condition
• Primary Purpose: Treatment
• Official Title: Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness
• Actual Study Start Date: July 1, 2019
• Estimated Primary Completion Date: February 28, 2022
• Estimated Study Completion Date: February 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in 12-item Multiple Sclerosis Walking Scale score [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   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.
2. Change in Fatigue Severity Scale score [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   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.
3. Change in Step Length [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   The distance (in centimeters) traversed in one step from initial contact of one foot to the initial contact of the opposite foot.
4. Change in Step Time [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   The time (in seconds) taken to complete one step from initial contact of one foot to the initial contact of the opposite foot.
5. Change in Stride Velocity [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   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
6. Change in Cadence [ Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up) ]
   The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Connecticut

Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States, 06112

Sponsors and Collaborators

Rutgers, The State University of New Jersey

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

More Information

• Responsible Party: Evan T. Cohen, SHRP Department of Rehabilitation and Movemen, Associate Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03963492
• Other Study ID Numbers: Pro2019000453
• First Posted: May 24, 2019
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evan T. Cohen, SHRP Department of Rehabilitation and Movemen, Rutgers, The State University of New Jersey:

Walking; Gait; Fatigue

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases