Intermittent vs Continuous Walking in People With Multiple Sclerosis

NCT03963492 | Suspended

• 1 other identifier: Pro2019000453
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Walking; Gait; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in 12-item Multiple Sclerosis Walking Scale score

  Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

• Change in Fatigue Severity Scale score

  Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

• Change in Step Length

  Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

• Change in Step Time

  Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

• Change in Stride Velocity

  Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

Study Arms (2)

Continuous Walking

ACTIVE COMPARATOR

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

Interval Walking

EXPERIMENTAL

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

Interventions

Walking 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.

Continuous Walking; Interval Walking

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Mount Sinai Rehabilitation Hospital: collaborator
• City University of New York, School of Public Health: collaborator

Study Sites (1)

Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Walking

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Evan T Cohen, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors blinded to experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled pre-post study

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 24, 2019
• Study Start: July 1, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)