Clinical trial NCT03109912: Do More, B'More, Live Fit
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Physical Activity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. Increase daily PA and measures of fitness
2. Improve lung clearance index (LCI) and participant HRQoL
3. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0)
timeFrame: Change from baseline at 6-months
measure: Daily activity via FitBit Step Count
timeFrame: Change from baseline at 6-months
Secondary outcomes:
measure: Pulmonary function testing (FEV1)
timeFrame: Change from baseline at 6-months
measure: Self-reported daily activity via the Habitual Activity Estimation Scale (HAES)
timeFrame: Change from baseline at 6-months
measure: Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)
timeFrame: Change from baseline at 6-months
measure: Exercise capacity via Modified Shuttle Walk Test (MSWT)
timeFrame: Change from baseline at 6-months
measure: Semi-structured interview
timeFrame: Change from baseline at 6-months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Peter Mogayzel, MD
role: PRINCIPAL_INVESTIGATOR
References: