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Cubii for Exercise in People With MS (Cubii)

Primary Purpose

Multiple Sclerosis, Fatigue, Activity, Motor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cubii elliptical
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria: Clinician-confirmed MS 18 years of age or older Walks with the aid of an assistive device (e.g., cane, walker, forearm crutches) Able to read and speak English Lives in the greater Seattle metropolitan area All genders Has an iPhone or Android phone that can download apps Exclusion Criteria: - People unable to exercise for health reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants using Cubii

    Arm Description

    Participants will use the Cubii exercise unit at their homes for two months as they choose. They will maintain a log regarding their use of the device. They will complete validated self-report questionnaires (demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) before and after the use of the exercise unit.

    Outcomes

    Primary Outcome Measures

    Change in activity - Godin Leisure Time Exercise Questionnaire
    A self-administered questionnaire asks the number of times one engages in mild, moderate, and strenuous activity for at least 15 minutes in a typical week. A higher score means more physically active.
    Change in activity - PROMIS Short Form v2.0 - Physical Function 20a
    The tool asks participants to rate the difficulty in performing twenty common activities of daily living. The total score will be used to evaluate changes in physical function.

    Secondary Outcome Measures

    Change in quality of life - MSQOL54- Quality of Life Subscale
    A structured, self-report questionnaire examining quality of life that contains 54-items, generating 12 subscales with two summary scores (physical health and mental health) and two additional single-item measures (satisfaction with sexual function and change in health). In scoring the MSQOL-54, two summary scores (physical and mental health) are produced from a weighted combination of scale scores, where scale scores range from 0 to 100, with higher scale score indicating improved quality of life.
    Change in pain intensity - PROMIS Pain Intensity Short Form 3a
    A structured, self-report questionnaire consisting of 3 items assessing pain intensity over the past seven days. A 5-point (from 1= Had no pain to 5= Very severe) rating scale is used in each of the 3 items. Higher results mean higher intensity of pain.
    Change in pain interference - PROMIS Pain Interference Scale (Short Form 8b, V1.0)
    A structured, self-report questionnaire examining the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Higher results mean higher interference of pain.
    Change in fatigue interference - PROMIS SF v1.0 - Fatigue-Multiple Sclerosis 8a
    A structured, self-report questionnaire consisting of 21 statements examining the effects of fatigue. Each statement is scored on a scale of 0-4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always). The total MFIS score can range from 0-84; the higher the score, the stronger the feelings of fatigue.
    Change in depression - PROMIS Short Form v1.0 Depression 8a
    A structured, self-report questionnaire consisting of 8 items examining negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher results mean greater depressive symptoms.
    Change in anxiety - PROMIS Short Form v1.0 - Anxiety 8a
    A structured, self-report questionnaire consisting of 6 items examining anxiety symptoms in the past 7 days. The lowest possible raw score is 6; the highest possible raw score is 30. Higher results mean greater anxiety symptoms.
    Change in fatigue intensity - Brief Fatigue Inventory (BFI)
    A structured, self-report questionnaire consisting of 9 items scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively.

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    April 20, 2023
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05826431
    Brief Title
    Cubii for Exercise in People With MS
    Acronym
    Cubii
    Official Title
    Feasibility, Acceptability, and Preliminary Efficacy of Cubii Under-desk Elliptical for Exercise in People With Multiple Sclerosis (PwMS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 19, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goals of this observational study are to evaluate (1) the feasibility, usability, and satisfaction with the Cubii elliptical and (2) the preliminary efficacy of the Cubii elliptical for increasing activity (primary outcome), physical function, and quality of life, and decreasing physical and psychological symptom (e.g., pain, fatigue, depression) severity in people with MS. The main question it aims to answer is how usable and feasible is the Cubii as a mode of exercise for people with MS? Participants will use the Cubii as they choose and keep a written log of this use. They will answer questions about their demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) and provide additional data regarding the feasibility, usability, and satisfaction with use of the Cubii.
    Detailed Description
    Data indicates people with MS are less active than their peers in the general population. Exercise interventions are important non-pharmacologic approach to maximize function and quality of life for people living with MS. Based on current evidence and expert opinion, the National Multiple Sclerosis Society (NMSS) recommends that healthcare providers promote the benefits of exercise and lifestyle physical activity for every person with MS. Individuals with at least moderate impairments (approximately 50% of MS population) often require adaptive exercise due to mobility and balance impairments. These individuals are likely to present with neurologic impairments that impact their gait and/or coordination and may experience limitations in walking distance and necessitate precautions for falls, as well as the use of assistive devices or compensatory strategies. The Cubii product line is well-placed for this subset of the MS population because it allows for safe, seated exercise that can still meet the recommendations for aerobic and resistance training. This study will capitalize on a representative, heterogeneous sample of MS patients who are seeking to change their coping behaviors around MS, including by exercising more, and an existing exercise unit that can be utilized by people with a range of mobility.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Fatigue, Activity, Motor, Quality of Life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants will use the equipment for two months as they choose, keep a log of their use, and answer pre- and post- participation questionnaires.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants using Cubii
    Arm Type
    Experimental
    Arm Description
    Participants will use the Cubii exercise unit at their homes for two months as they choose. They will maintain a log regarding their use of the device. They will complete validated self-report questionnaires (demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) before and after the use of the exercise unit.
    Intervention Type
    Device
    Intervention Name(s)
    Cubii elliptical
    Intervention Description
    Low impact, portable, and compact elliptical for seated use.
    Primary Outcome Measure Information:
    Title
    Change in activity - Godin Leisure Time Exercise Questionnaire
    Description
    A self-administered questionnaire asks the number of times one engages in mild, moderate, and strenuous activity for at least 15 minutes in a typical week. A higher score means more physically active.
    Time Frame
    [Baseline, Week 9
    Title
    Change in activity - PROMIS Short Form v2.0 - Physical Function 20a
    Description
    The tool asks participants to rate the difficulty in performing twenty common activities of daily living. The total score will be used to evaluate changes in physical function.
    Time Frame
    [Baseline, Week 9
    Secondary Outcome Measure Information:
    Title
    Change in quality of life - MSQOL54- Quality of Life Subscale
    Description
    A structured, self-report questionnaire examining quality of life that contains 54-items, generating 12 subscales with two summary scores (physical health and mental health) and two additional single-item measures (satisfaction with sexual function and change in health). In scoring the MSQOL-54, two summary scores (physical and mental health) are produced from a weighted combination of scale scores, where scale scores range from 0 to 100, with higher scale score indicating improved quality of life.
    Time Frame
    [Baseline, Week 9
    Title
    Change in pain intensity - PROMIS Pain Intensity Short Form 3a
    Description
    A structured, self-report questionnaire consisting of 3 items assessing pain intensity over the past seven days. A 5-point (from 1= Had no pain to 5= Very severe) rating scale is used in each of the 3 items. Higher results mean higher intensity of pain.
    Time Frame
    [Baseline, Week 9
    Title
    Change in pain interference - PROMIS Pain Interference Scale (Short Form 8b, V1.0)
    Description
    A structured, self-report questionnaire examining the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Higher results mean higher interference of pain.
    Time Frame
    [Baseline, Week 9
    Title
    Change in fatigue interference - PROMIS SF v1.0 - Fatigue-Multiple Sclerosis 8a
    Description
    A structured, self-report questionnaire consisting of 21 statements examining the effects of fatigue. Each statement is scored on a scale of 0-4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always). The total MFIS score can range from 0-84; the higher the score, the stronger the feelings of fatigue.
    Time Frame
    [Baseline, Week 9
    Title
    Change in depression - PROMIS Short Form v1.0 Depression 8a
    Description
    A structured, self-report questionnaire consisting of 8 items examining negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher results mean greater depressive symptoms.
    Time Frame
    [Baseline, Week 9
    Title
    Change in anxiety - PROMIS Short Form v1.0 - Anxiety 8a
    Description
    A structured, self-report questionnaire consisting of 6 items examining anxiety symptoms in the past 7 days. The lowest possible raw score is 6; the highest possible raw score is 30. Higher results mean greater anxiety symptoms.
    Time Frame
    [Baseline, Week 9
    Title
    Change in fatigue intensity - Brief Fatigue Inventory (BFI)
    Description
    A structured, self-report questionnaire consisting of 9 items scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively.
    Time Frame
    [Baseline, Week 9

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinician-confirmed MS 18 years of age or older Walks with the aid of an assistive device (e.g., cane, walker, forearm crutches) Able to read and speak English Lives in the greater Seattle metropolitan area All genders Has an iPhone or Android phone that can download apps Exclusion Criteria: - People unable to exercise for health reasons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurie Kavanagh
    Phone
    206-668-4168
    Email
    lauriek@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Alschuler, PhD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cubii for Exercise in People With MS

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