Feasibility, Acceptability, and Preliminary Efficacy of Cubii Under-desk Elliptical for Exercise in People With Multiple Sclerosis (PwMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Average Daily Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •People unable to exercise for health reasons
结局指标
主要结局
Average Daily Use
时间窗: Baseline - Week 9
Average minutes participants used the device each day
Change in Activity - Godin Leisure Time Exercise Questionnaire
时间窗: [Baseline, Week 9
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.
Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a
时间窗: [Baseline, Week 9
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.
Device Utilization
时间窗: Baseline - Week 9
Qualitative findings: a narrative summary of participant responses to interview questions about using the device.
次要结局
- Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale([Baseline, Week 9)
- Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a([Baseline, Week 9)
- Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0)([Baseline, Week 9)
- Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a([Baseline, Week 9])
- Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a([Baseline, Week 9)
- Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a([Baseline, Week 9)
- Change in Fatigue Intensity - Brief Fatigue Inventory (BFI)([Baseline, Week 9)
研究者
Kevin Alschuler
Professor: Rehabilitation Medicine
University of Washington