Feasibility and Initial Efficacy of a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Study Feasibility: Number of Participants Recruited
研究概览
简要总结
The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are:
- Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)?
- Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews?
- Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program.
Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.
详细描述
The proposed study will use a randomized controlled design to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with MS compared with an attention/contact wellness control condition. Feasibility testing is essential for (a) learning if an intervention can be delivered and then (b) refining the approach before conducting an expensive, fully powered efficacy study. The primary outcome of interest is process and resource feasibility as measured by participant recruitment, retention, and safety. The secondary outcome of interest is acceptability, specifically participant satisfaction and perceptions, assessed through an evaluation survey and semi-structured interviews. The tertiary outcomes encompass scientific outcomes of interest for larger efficacy trials (i.e., metabolic health outcomes, MS symptoms, and exercise behavior change).
Twenty-four participants will be recruited and randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program. Recruitment, screening, and enrollment will be completed by a graduate research assistant and the intervention will be delivered online by the PI through one-on-one behavioral coaching. Data regarding the primary, secondary, and tertiary outcomes will be collected at throughout the study period.
The proposed study includes three specific aims and hypotheses:
Specific Aim 1: Evaluate the feasibility (i.e., recruitment, retention, and safety) of an exercise training intervention and attention/contact wellness control condition delivered over a 16-week period in a sample of 24 adult wheelchair users with MS from the Dallas-Fort Worth Metroplex.
Hypothesis 1: The study protocol will be feasible in terms of reaching recruitment goals (n=24; 12 per group) within a one-year period, retaining 80% or more of those participants through the full 16-week study period, and safe in terms of <10% of participants reporting adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •diagnosis of MS
- •self-reported use of a wheelchair (i.e., manual wheelchair, power wheelchair, or scooter) >50% of the time
- •age of 18 years or older
- •relapse free for the past 30 days
- •being non-active defined as not engaging in regular physical activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months (i.e., not meeting current physical activity guidelines for MS)
排除标准
- •during telephone screening participants will complete an exercise pre-participation health screen and if participants report any symptoms or conditions contradictive of exercise then physician clearance will be required before enrollment
研究组 & 干预措施
Exercise Training Intervention
干预措施: Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition (Behavioral)
Wellness Control
干预措施: WEllness for Longevity Living with MS (WELL)- Control Condition (Behavioral)
结局指标
主要结局
Study Feasibility: Number of Participants Recruited
时间窗: 16-weeks
Feasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period.
Study Feasibility: Number of Participants Retained
时间窗: 16-weeks
Feasibility of the intervention will be measured based on retention of \>80% of enrolled participants for the full 16-week study period.
Study Feasibility: Number of Participants With Study-Related Adverse Events
时间窗: 16-weeks
次要结局
- Acceptability: Number of Participants With Positive Perceptions During Semi-Structured Interview(16-weeks)
- Acceptability as Measured by the Post-intervention Acceptability Survey(16-weeks)
研究者
Stephanie Lee Silveira
Assistant Professor
The University of Texas Health Science Center, Houston