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Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimodal Exercise Group
Waitlist
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must be aged 40-65 years old to be enrolled in this study. Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered. Subjects must have a confirmed diagnosis of MS by the treating neurologist be free from MS relapses in the last 30 days have an Expanded Disability Status Scale (EDSS) score ≤ 6.0 be fluent in spoken and written English. Exclusion Criteria: unable to walk unassisted for at least ten meters are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.) exhibit severe cognitive impairment (as determined by a Mini-Cog score <3) are diagnosed with active psychiatric problems. unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis) arthritis of the lower limbs acute lower back or lower limbs pain rheumatic and/or severe orthopedic problems that may interfere with resistance training.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control Group

    Multimodal Exercise Group

    Arm Description

    Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.

    Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.

    Outcomes

    Primary Outcome Measures

    Primary Outcome
    Preliminary efficacy of multimodal exercise in improving frailty [Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    September 14, 2023
    Sponsor
    University of Kansas Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06042244
    Brief Title
    Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis
    Official Title
    Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Kansas Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.
    Arm Title
    Multimodal Exercise Group
    Arm Type
    Experimental
    Arm Description
    Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.
    Intervention Type
    Other
    Intervention Name(s)
    Multimodal Exercise Group
    Intervention Description
    Listed in arm/ group descriptions
    Intervention Type
    Other
    Intervention Name(s)
    Waitlist
    Intervention Description
    listed in arm/group description
    Primary Outcome Measure Information:
    Title
    Primary Outcome
    Description
    Preliminary efficacy of multimodal exercise in improving frailty [Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be aged 40-65 years old to be enrolled in this study. Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered. Subjects must have a confirmed diagnosis of MS by the treating neurologist be free from MS relapses in the last 30 days have an Expanded Disability Status Scale (EDSS) score ≤ 6.0 be fluent in spoken and written English. Exclusion Criteria: unable to walk unassisted for at least ten meters are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.) exhibit severe cognitive impairment (as determined by a Mini-Cog score <3) are diagnosed with active psychiatric problems. unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis) arthritis of the lower limbs acute lower back or lower limbs pain rheumatic and/or severe orthopedic problems that may interfere with resistance training.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tobia Zanotto, PhD
    Phone
    217-721-4852
    Email
    tzanotto@kumc.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

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