Clinical trial NCT05826431: Cubii for Exercise in People With MS
Official title: Feasibility, Acceptability, and Preliminary Efficacy of Cubii Under-desk Elliptical for Exercise in People With Multiple Sclerosis (PwMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Activity, Motor
Quality of Life
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Average Daily Use
timeFrame: Baseline - Week 9
measure: Change in Activity - Godin Leisure Time Exercise Questionnaire
timeFrame: [Baseline, Week 9
measure: Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a
timeFrame: [Baseline, Week 9
measure: Device Utilization
timeFrame: Baseline - Week 9
Secondary outcomes:
measure: Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale
timeFrame: [Baseline, Week 9
measure: Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a
timeFrame: [Baseline, Week 9
measure: Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0)
timeFrame: [Baseline, Week 9
measure: Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a
timeFrame: [Baseline, Week 9]
measure: Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a
timeFrame: [Baseline, Week 9
measure: Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a
timeFrame: [Baseline, Week 9
measure: Change in Fatigue Intensity - Brief Fatigue Inventory (BFI)
timeFrame: [Baseline, Week 9
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Kevin Alschuler, PhD
role: PRINCIPAL_INVESTIGATOR
References: