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Intermittent vs Continuous Walking in People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Walking

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Walking, Gait, Fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Walking

Interval Walking

Arm 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

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

Outcomes

Primary Outcome Measures

Change in 6-minute Walk Test distance

Is a measurement of the distance (in meters) walked at best pace in six minutes.

Secondary Outcome Measures

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.

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.

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.

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.

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

Change in Cadence

The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute

Full Information

NCT ID

NCT03963492

First Posted

May 16, 2019

Last Updated

May 11, 2022

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Mount Sinai Rehabilitation Hospital, City University of New York, School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT03963492

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Suspended

Why Stopped

COVID-19 Pandemic

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

Mount Sinai Rehabilitation Hospital, City University of New York, School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Walking, Gait, Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled pre-post study

Masking

Outcomes Assessor

Masking Description

Assessors blinded to experimental condition

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous Walking

Arm Type

Active Comparator

Arm Description

Arm Title

Interval Walking

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Walking

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in 6-minute Walk Test distance

Description

Is a measurement of the distance (in meters) walked at best pace in six minutes.

Time Frame