High Intensity Interval Gait Training in Multiple Sclerosis

The Effects of High Intensity Interval Gait Training vs. Moderate Intensity Continuous Gait Training in Multiple Sclerosis

Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: High Intensity Interval Gait training; Behavioral: Moderate Intensity Interval gait training

Detailed Description

Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.

Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?

Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.

Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.

Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herb Karpatkin, DSc; Phone Number: 212-396-7115; Email: hkarpatk@hunter.cuny.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 11238
      • Recruiting
      • Hunter College
      • Contact: Herb Karpatkin, DSc; Phone Number: 212-396-7115; Email: hkarpatk@hunter.cuny.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persons diagnosed with Multiple Sclerosis.
• The ability to walk for 6 minutes continuously with or without assistive device.
• The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
• Above the age of 18

Exclusion Criteria:

• Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
• Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Interval gait training; subjects will receive 3x/week high intensity interval training for 20 minutes over a 4 week period	Behavioral: High Intensity Interval Gait training; Subjects will walk as fast as they can for 30 seconds, followed by a 60 second seated recovery. They will be guarded by a physical therapist at all times.
Active Comparator: Moderate intensity continuous gait training; subjects will receive 3x/week moderate intensity continuous gait training for 20 minutes over a 4 week period	Behavioral: Moderate Intensity Interval gait training; subjects will walk for 20 minutes at theri best comfortable pace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Six minute walk test time from before to after the intervention	Subjects will walk for six minutes at their best comfortable pace. They will be guarded by physical therapist for the entire walk. Total distance, distance per minute, and heart rate will be measured.	The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional gait assessment score from before to after the intervention	Used to assess balance during different walking conditions	Will be done in the week before and the week after the intervention.Will be done in the week before and the week after the intervention.
Change in Hand held dynamometry values from before to after the intervention	Use of the strain gauge to determine lower extremity muscle strength	Will be done the week before and the week after the intervention.
Change in Multiple sclerosis impact scale 29 from before to afterthe intervention	Quality of life measure where are the subject subjectively rates the impact of multiple sclerosis on their life	Performed in the week before and the week after the intervention.

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• 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: 2022-0261

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