Do More, B'More, Live Fit: An Outpatient Fitness-training Pilot Program Designed to Optimize the Habit of Exercise in Adolescents and Young Adults With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0)
研究概览
简要总结
Physical activity (PA) in individuals with cystic fibrosis (CF) improves exercise capacity, slows decline in lung function, increases mucus clearance and improves health-related quality of life (HRQoL). Establishing and maintaining an exercise routine remains challenging and programs promoting PA in people with CF have poor participation. Moreover, while the positive effects of physical conditioning on lung function have been well reported, conventional measurements of lung function may lack the sensitivity to reveal improvement in mild lung disease.
This randomized control trial (RCT; N = 60) evaluates the Do More, B'More, Live Fit, a 6-month fitness program designed to optimize exercise habits of 12-21 year-olds with CF through structured exercises with personalized coaching, exercise equipment including the FitBit Flex, online support and motivational messages delivered electronically. The intervention incorporates fitness preferences and encompasses endurance, strength and flexibility exercises while adjusting to physical fitness needs. The hypothesis is that intervention participants will have increased and sustained engagement and better health outcomes compared to control group participants. The investigators' specific aims are to:
- Increase daily PA and measures of fitness
- Improve lung clearance index (LCI) and participant HRQoL
- Demonstrate feasibility, accessibility and satisfaction of intervention using semi-structured interviews
The results of this pilot evaluation of the Do More, B'More, Live Fit program will offer novel insight into factors that sustain engagement in exercise programs and identify if LCI is an appropriate clinical outcome to assess PA interventions. Results will inform future RCT of interventions to optimize exercise habits of adolescents with CF.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-21 year-old patients with a diagnosis of cystic fibrosis that are cared for at Johns Hopkins
- •Participants must have smart phone and/or computer with universal serial bus (USB) access to set-up FitBit Flex
排除标准
- •Forced expiratory volume in 1 second (FEV1) < 40% predicted
- •Individuals already participating in vigorous physical activity as assessed by the study team such as participating in year-round organized sports and/or aerobic exercise >30 minutes more than 5 times/week may or may not be included in this study at the discretion of the PI and study team.
结局指标
主要结局
Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0)
时间窗: Change from baseline at 6-months
LCI is measured via multiple breath washout (MBW) using a device called the EXHALYZER D. MBW is a non-invasive test that measures how difficult it is for air to leave the lungs and currently, the use of the EXHALYZER D is investigational. For MBW, participants breathe oxygen for about 3-5 minutes using a mouthpiece and normal breathing without any special breathing maneuvers.
Daily activity via FitBit Step Count
时间窗: Change from baseline at 6-months
Daily step count (mean, median and highest daily) recorded through participant FitBit flex
次要结局
- Pulmonary function testing (FEV1)(Change from baseline at 6-months)
- Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)(Change from baseline at 6-months)
- Self-reported daily activity via the Habitual Activity Estimation Scale (HAES)(Change from baseline at 6-months)
- Exercise capacity via Modified Shuttle Walk Test (MSWT)(Change from baseline at 6-months)
- Semi-structured interview(Change from baseline at 6-months)