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)
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a | Mean Difference (Final Values) 0.61 | 0.103 | |
| Change in Activity - Godin Leisure Time Exercise Questionnaire | Mean Difference (Final Values) 18.65 | 0.153 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Cubii elliptical
Results by group
Average Daily Use
Baseline - Week 9
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Participants Using Cubii | 19.72 Minutes | 0.59 (Standard Deviation) | 20 |
Change in Activity - Godin Leisure Time Exercise Questionnaire
[Baseline, Week 9
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Participants Using Cubii | 25.95 units on a scale | 40.73 (Standard Deviation) | 20 |
| Participants Using Cubii | 44.60 units on a scale | 85.76 (Standard Deviation) | 20 |
Participants Using Cubii
Participants Using Cubii
p = 0.153; Mean Difference (Final Values) 18.65
Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a
[Baseline, Week 9
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Participants Using Cubii | 40.49 units on a scale | 2.54 (Standard Deviation) | 20 |
| Participants Using Cubii | 41.10 units on a scale | 2.22 (Standard Deviation) | 20 |
Participants Using Cubii
Participants Using Cubii
p = 0.103; Mean Difference (Final Values) 0.61
Device Utilization
Baseline - Week 9
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Participants Using Cubii | 14 Participants | 20 | |
| Participants Using Cubii | 18 Participants | 20 | |
| Participants Using Cubii | 17 Participants | 20 | |
| Participants Using Cubii | 14 Participants | 20 | |
| Participants Using Cubii | 13 Participants | 20 | |
| Participants Using Cubii | 14 Participants | 20 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Participants Using Cubii | 20 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Average Daily Use
Baseline - Week 9
Change in Activity - Godin Leisure Time Exercise Questionnaire
[Baseline, Week 9
Physical functionChange in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a
[Baseline, Week 9
Quality of life (reported by participants)Device Utilization
Baseline - Week 9
Other measures (7)
Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale
[Baseline, Week 9
Bladder, bowel and sexual functionQuality of life (reported by participants)Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a
[Baseline, Week 9
PainQuality of life (reported by participants)Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0)
[Baseline, Week 9
Thinking and memoryPainMood and sleepQuality of life (reported by participants)Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a
[Baseline, Week 9]
FatigueQuality of life (reported by participants)Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a
[Baseline, Week 9
Thinking and memoryPhysical functionMood and sleepQuality of life (reported by participants)Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a
[Baseline, Week 9
Mood and sleepQuality of life (reported by participants)Change in Fatigue Intensity - Brief Fatigue Inventory (BFI)
[Baseline, Week 9
FatigueWalking and mobilityMood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Apr 2023
Main results due
Aug 2023
Finished
Dec 2023
Results posted
Dec 2024