Cubii for Exercise in People With MS (Cubii)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Multiple Sclerosis; Fatigue; Activity, Motor
• Intervention / Treatment: Device: Cubii elliptical

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98133
      • UW Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants using Cubii; 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; Low impact, portable, and compact elliptical for seated use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Use	Average minutes participants used the device each day	Baseline - Week 9
Change in Activity - Godin Leisure Time Exercise Questionnaire	The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin & Shephard, 1985) is a 4-item self-administered questionnaire seeking information re: the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. The GLTEQ was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise. Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, & Boullon, 1986). Higher scores indicate greater exercise engagement.	[Baseline, Week 9
Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a	The tool asks participants to rate the difficulty in performing twenty common activities of daily living using scale that ranges from 1-5, where 1=unable to do and 5=without any difficulty. The total raw score is calculated by summing the individual responses. A higher score indicates higher function.	[Baseline, Week 9
Device Utilization	Qualitative findings: a narrative summary of participant responses to interview questions about using the device.	Baseline - Week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (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 scores range from 0 to 100. A higher score indicates improved quality of life.	[Baseline, Week 9
Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a	Patient-reported pain intensity consisting of 3 items assessing pain intensity over the past seven days. Each item is scored 1 (no pain) to 5 (very severe pain) yielding a raw score between 3 to 15, which is converted to a standard t-score. Higher scores indicate greater self-reported intensity of pain.	[Baseline, Week 9
Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0)	A structured, self-report questionnaire consisting of 8 items measuring the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities (e.g., how much did pain interfere with your day-to-day activities). Each item is scored 1 (not at all) to 5 (very much).The total raw score is calculated by summing the individual responses. The raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.	[Baseline, Week 9
Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 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 - Patient-Reported Outcomes Measurement Information System (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). Respondents rate the strength of agreement with statements about depressive symptoms using a 1-5 scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). The total raw score is calculated by summing the individual responses. The raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.	[Baseline, Week 9
Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a	A structured, self-report questionnaire consisting of 6 items examining anxiety symptoms in the past 7 days using a 5-point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always). The lowest possible raw score is 6; the highest possible raw score is 30. Higher results mean greater anxiety symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.	[Baseline, Week 9
Change in Fatigue Intensity - Brief Fatigue Inventory (BFI)	The BFI is a 9-item, 11-point rating scale developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours.	[Baseline, Week 9

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Kevin Alschuler, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: STUDY00016696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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