Do More, B'More, Live Fit

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.

Conditions

• Cystic Fibrosis
• Physical Activity

Interventions

BEHAVIORAL

Personalized-Coaching Interventions

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.

BEHAVIORAL

Motivational Messages

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.

BEHAVIORAL

Online Exercise Tutorials

Participants are given access to Do More, B'More, Live Fit webpage which includes spotlighted exercises, instructional exercise photos and videos.

BEHAVIORAL

Social Support and Peer Challenges

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.

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Peter Mogayzel, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-17

Primary Completion

2017-02-28

Completion

2017-02-28