Pilot RCT Study Using a Fitbit Device to Improve Exercise Tolerance in 80 Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Graded exercise test (Submaximal GXT)
研究概览
简要总结
In this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year.
详细描述
The aim of this study is to evaluate whether the use of a Fitbit device and an exercise prescription is associated with increased daily activity and in turn increased exercise tolerance in young adult patients with cystic fibrosis (CF). The investigators hypothesize that use of the Fitbit and an exercise prescription will be associated with increased exercise tolerance compared to standard counseling and an exercise prescription alone.
For patients with CF, young adulthood and adolescence is a significant time of vulnerability. In addition to normal behavioral challenges of adolescence and young adulthood (seeking independence/autonomy while also choosing rebellion), those with CF are often dealing with significant disease progression. Therefore, working in new innovative ways to improve adherence to regimens that improve lung function such as exercise are needed to continue to support patients during this vulnerable time.
Studies of patients with cystic fibrosis have shown that regular exercise training can decrease rate of lung function decline, potentially improve lung function, and improve aerobic capacity. However, many patients do not include regular exercise in their daily routine. Successful strategies to improve adherence include providing patient specific guidelines for an appropriate exercise program, supporting participation and providing positive feedback. Overall, exercise is a crucial diagnostic and therapeutic modality for patients with Cystic Fibrosis, although awareness somewhat limited. The adult CF program at Boston Children's and Brigham & Women's Hospital established an inpatient and outpatient exercise program as part of a quality improvement effort. Patients are prescribed an individualized exercise program or exercise prescription based on their assessment during a sub-maximal effort. This program has been successful but given the rigors of daily life (e.g. school, work, family obligations), adherence is a concern with resources limiting more rigorous feedback to maintain this essential life activity.
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
- 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
- •A diagnosis of Cystic Fibrosis
- •Age 18 and over
- •Must be able to complete at least level 1 of the baseline exercise fitness test
- •Must not have required IV antibiotics for a CF exacerbation within 30 days of starting the program
排除标准
- •Pregnancy at enrollment
- •A history of CF exacerbation requiring IV antibiotics within last month
- •Use of a fitness tracker or similar product within 6 months of enrollment
结局指标
主要结局
Graded exercise test (Submaximal GXT)
时间窗: Two years (Enrollment, 6 months, 12 months, 24 months)
Change is submaximal GXT will be assessed for all participants
次要结局
- Fitbit activity data(Two years)
- Relative change from baseline in ppFEV1(Two years)
- Overall qualitative assessment of participant's potential barriers to Fitbit use(Two years (6 Month Time Point))
- Relative change from baseline in ppFEF25-75(Two years)
- BMI(Two years)
- Overall qualitative assessment of the participant's use of the social media associated with the device(Two years (6 Month Time Point))
- HAES (Habitual Activity Estimation Scale)(Two years)
- Relative change from baseline in ppFVC(Two years)
- CFQ-R (Survey on Quality of Life in Cystic Fibrosis)(Two years)
- Overall qualitative assessment of participant satisfaction with the Fitbit(Two years (6 Month Time Point))
- Incidence of exacerbations requiring IV antibiotics(Two years)
- GAD-7(Two years (Enrollment, 6 months, 12 months, 18 months, 24 months))
- PHQ9(Two years (Enrollment, 6 months, 12 months, 18 months, 24 months))
研究者
Ahmet Uluer
Director, Adult Cystic Fibrosis Program
Boston Children's Hospital