Do More, B'More, Live Fit
Condition: Cystic Fibrosis; Physical Activity
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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.
    


Intervention name(s): Personalized-Coaching Interventions; Motivational Messages; Online Exercise Tutorials; Social Support and Peer Challenges
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): At the baseline fitness assessment, participants receive exercise prescriptions based upon their individual assessment. One of the ultimate exercise prescription goals is to achieve 30-minutes of an endurance-style exercise 5 times/week which may vary depending upon baseline fitness assessment. Aside from team sports, endurance-style exercise prescriptions may include simply walking, jump roping or stair climbing to more complex Tabata-style workouts. Two additional physical therapy (PT) 30-minute appointments are scheduled about 4-6 weeks and 8-10 weeks from enrollment. These 30-minute PT follow-up appointments will vary based on initial assessment and previous exercise prescription success but will include strength training for major muscles groups and/or flexibility exercises with yoga as well as reinforcement of previously learned techniques. PT will add additional individualized recommendations.; Intervention participants are enrolled to receive motivational messages starting 14 days after enrollment via preferred contact method (SMS, telephone call and/or email) every 3-4 days over the 6-month study period.; Participants are given access to Do More, B'More, Live Fit webpage which includes spotlighted exercises, instructional exercise photos and videos.; Participants are invited to join the Do More, B'More, Live Fit Activity Group via the FitBit Dashboard and are invited to friend the study team members and other exercise-intervention participants in order to take part in FitBit step-goal challenges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment