Increasing Physical Activity in Recovered Persons With Multiple Sclerosis Through Daily Sensor Based Feedback and Weekly Focus Group Meetings: A Feasibility and Pilot II Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The 2 minute walking test
研究概览
简要总结
The aim of htis study is to investigate the post intervention effects of daily feedback on actual physical activity levels derived from a wristworn accelerometer FITBIT combined with self-management training on in-clinic physical activity in persons with moderate to severe disability from MS.
详细描述
Evidence from various sources indicate that physical activities and mobility practice are beneficial to maintain or increase functional levels in persons with Multiple sclerosis. Even so persons with moderate and severe disability from Multiple sclerosis are less active in daily life than their healthy counterparts. Also during hospital stay persons with MS tend to remain relatively sedentary outside of their rehabilitation sessions. Feedback about physical activity enabled by wearable sensors combined with behavioral strategies to improve self-efficacy and motivation are potential method increase physical activity in hospital inpatients. The primary purpose of this feasibility and interventional study was to determine whether a minimalist physical activity tracker-based feedback and self efficacy training would lead to an increase in physical activity, mobility and quality of life measures during recovery in a group of persons with MS compared to a control group that does not receive feedback. Secondary purpose was to verify if this intervention during recovery would lead to increased perceived physical activity in daily home life after discharge and over longer periods (Follow up at 6 weeks). The study participants will be 60 persons that have moderate to severe disability due to MS, that are admitted to MS Centre of the Santa Maria Nascente Institute, Don Gnocchi Foundation (Milan, Italy). Participants will all receive standard rehabilitation offered in the center. All participants will wear the accelerometer device (FitBit Charge tracker, FitBit Inc, CA, USA) 24 hours per day in order to measure physical activity levels during their hospital stay (3-4 weeks. The participants will be randomized to a group that has no feedback of physical activity level and a group that will have an active feedback intervention (AF). The active feedback intervention will consist of daily feedback, received through a Fitbit application downloaded on their telephones, on whether or not their target activity level was met and how far they were from the target. Additionally, the participants will participate in weekly meeting group focused on enhancing behavioral strategies to increase self-efficacy and motivation. Covariates such as age, sex, stage of change for physical activity behavior, clinical mobility, fatigue, health perception and goal commitment will be measured in all 60 participants both pre and post the intervention/hospital recovery period. The long-term effects on daily perceived functional mobility and self-efficacy will be investigated six weeks after discharge through questionnaires during a telephone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessor will be blind to participants' intervention assignment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS according to the McDonald's criteria McDonald Criteria 2010
- •EDSS score >4.5-7
- •Freedom from relapses and steroid treatment for at least 1 month
- •Ability to walk at least 10 meters independently with or without support
- •MS without relapses in the last 3 months
排除标准
- •Mini Mental State Examination (MMSE) score < 20
- •The presence of disabling pain or severe deficit of visual acuity
- •The presence of severe deficit in communication and severe dysmetry
结局指标
主要结局
The 2 minute walking test
时间窗: Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks
The 2 minute walking test is used to understand functional mobility. A smaller distance covered (in meters) represents a worse outcome.
The Self-Efficacy in Multiple Sclerosis Scale
时间窗: Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks
The Self-Efficacy in Multiple Sclerosis Scale is a questionnaire of perceived self-efficacy of MS patients
Number of passes with Fitbit wristband
时间窗: Change from number of passes at baseline to number of passes after 4 weeks will be measured.
A Fitbit wristband consists of an accelerometer and a memory unit and is used to collect mobility data, in the form of number of passes. More passes carried out during the period of wearing the wristband the better.
次要结局
- The 10 meters walking scale(Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks)
- The Short Form-12 questionnaire(Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at baseline Day 1 after 4 weeks and after 10 weeks)
- The Fatigue severity Scale(Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks)
- The EQ-5D visual analogue scale(Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks)
- The Twelve Item MS Walking Scale(Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks)
- The Physical Activity Disability Survey-Revised questionnaire(Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks)