Cubii for Exercise in People With MS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility, Acceptability, and Preliminary Efficacy of Cubii Under-desk Elliptical for Exercise in People With Multiple Sclerosis (PwMS)

Conditions
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Multiple Sclerosis, Fatigue, Activity, Motor, Quality of Life

Intervention / Treatment
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* Device: Cubii elliptical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants using Cubii<br>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. | Device: Cubii elliptical<br>* Low impact, portable, and compact elliptical for seated use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 | 
| 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. | [Baseline, Week 9 |