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Comparison of Intermittent vs. Continuous Walking in MS

Primary Purpose

Multiple Sclerosis, Endurance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
type of walking
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Endurance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Positive diagnosis of MS
  • Ambulatory for at least 6 minutes with or without an assistive device (e.g. cane, crutches or orthotics)
  • Ability to read, understand, and sign an informed consent form

Exclusion Criteria:

  • Evidence of exacerbation in the prior three months as defined by a treating physician
  • Orthopedic or cardiovascular condition that would interfere with ability to walk for 6 continuous minutes,
  • Currently being on an active physical rehabilitation program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intermittent walking training

    Continuous Walking Training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pre to post change in 6 Minute walk test distance

    Secondary Outcome Measures

    Visual Analog Scale of fatigue
    Measurements to be taken at baseline and after each 4 week intervention

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    March 31, 2016
    Sponsor
    Hunter College of City University of New York
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02726373
    Brief Title
    Comparison of Intermittent vs. Continuous Walking in MS
    Official Title
    The Effect of Intermittent vs. Continuous Walking Training on Walking Endurance and Fatigue in People With Multiple Sclerosis: a Randomized, Crossover Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hunter College of City University of New York

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: To compare effects of an intermittent and continuous walking program on walking endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week detraining period, participants performed the second training condition.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intermittent walking training
    Arm Type
    Experimental
    Arm Title
    Continuous Walking Training
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    type of walking
    Intervention Description
    Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over
    Primary Outcome Measure Information:
    Title
    Pre to post change in 6 Minute walk test distance
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale of fatigue
    Description
    Measurements to be taken at baseline and after each 4 week intervention
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Positive diagnosis of MS Ambulatory for at least 6 minutes with or without an assistive device (e.g. cane, crutches or orthotics) Ability to read, understand, and sign an informed consent form Exclusion Criteria: Evidence of exacerbation in the prior three months as defined by a treating physician Orthopedic or cardiovascular condition that would interfere with ability to walk for 6 continuous minutes, Currently being on an active physical rehabilitation program

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Intermittent vs. Continuous Walking in MS

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