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出境医 / 临床实验 / Intermittent vs Continuous Walking in People With Multiple Sclerosis

Intermittent vs Continuous Walking in People With Multiple Sclerosis

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
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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, 2021
Estimated Study Completion Date : February 28, 2021
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
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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
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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
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Principal Investigator: Evan T Cohen, PhD Rutgers, The State University of New Jersey
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent vs Continuous Walking in People With Multiple Sclerosis
Official Title  ICMJE Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Walking
  • 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
    Intervention: Other: Walking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963492
Other Study ID Numbers  ICMJE Pro2019000453
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Evan T. Cohen, SHRP Department of Rehabilitation and Movemen, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • Mount Sinai Rehabilitation Hospital
  • City University of New York, School of Public Health
Investigators  ICMJE
Principal Investigator: Evan T Cohen, PhD Rutgers, The State University of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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