NCT05826431

Cubii for Exercise in People With MS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Cubii elliptical	Low impact, portable, and compact elliptical for seated use.

Timeline

• Start date: 2023-04-19
• Primary completion: 2023-08-31
• Completion: 2023-12-04
• First posted: 2023-04-24
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study