Do More, B'More, Live Fit

Johns Hopkins University

Status: Completed

Conditions: Physical Activity; Cystic Fibrosis

Treatments: Behavioral: Motivational Messages; Behavioral: Social Support and Peer Challenges; Behavioral: Personalized-Coaching Interventions; Behavioral: Online Exercise Tutorials

Study type: Interventional

Funder types: Other

Identifiers

NCT03109912

IRB00055571

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Control

No Intervention group

Description:

At the baseline fitness assessment, the FitBit daily step goal is set at the manufacturer standard 10,000 steps. Throughout the study, these 30 participants will receive generic, non-personalized encouragement and recommendations (if requested by the participant) for PA at routine clinic visits, baseline and follow-up assessments at 3 and 6 month clinic visits. At the 3-month and 6-month visits, exercise is reinforced with generic encouragement, export FitBit data and review any missing data concerning for equipment failure or user error.

Exercise Intervention

Experimental group

Description:

The baseline fitness assessment includes an additional 30-minutes for exercise prescriptions; participant FitBit daily step goal is set based on a collaborative review between the participant and PT and participants receive individualized exercise prescriptions based on their assessment. Throughout the study, these 30 participants will receive customized encouragement and personalized fitness recommendations for PA at routine visits, baseline and follow-up assessments at 3 and 6 month clinic visits. At the 3-month and 6-month visits, study team members meet again with the participant for an additional 30-45 minutes to reinforce exercise through exercise prescriptions and individualized encouragement, export FitBit data and review any missing data concerning for equipment failure or user error and address any specific exercise concerns. FitBit daily step goals may be adjusted based on collaborative review between the participant and PT.

Treatment:

Behavioral: Online Exercise Tutorials

Behavioral: Social Support and Peer Challenges

Behavioral: Personalized-Coaching Interventions

Behavioral: Motivational Messages