N/A
N=21
Cubii for Exercise in People With MS
Multiple Sclerosis · Fatigue · Activity, Motor · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT05826431 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Average Daily Use — 19.72 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cubii elliptical (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Use |
19.72 | — |
| PRIMARY Change in Activity - Godin Leisure Time Exercise Questionnaire |
25.95; 44.60 | 0.153 |
| PRIMARY Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a |
40.49; 41.10 | 0.103 |
| PRIMARY Device Utilization |
14; 18; 17; 14; 13; 14 | — |
| SECONDARY Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale |
59.74; 63.95 | .083 |
| SECONDARY Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a |
54.21; 53.95 | 0441 |
| SECONDARY Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0) |
54.72; 57.32 | 0.095 |
| SECONDARY Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a |
59.36; 59.39 | 0.487 |
| SECONDARY Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a |
48.20; 48.15 | 0.483 |
| SECONDARY Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a |
48.72; 45.90 | .0483 sig |
| SECONDARY Change in Fatigue Intensity - Brief Fatigue Inventory (BFI) |
6.60; 6.18 | 0.123 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05826431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.