Do More, B'More, Live Fit

NCT ID: NCT03109912

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-17
• Study Completion Date: 2017-02-28

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.

Conditions

Cystic Fibrosis; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise Intervention

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.

Group Type: EXPERIMENTAL

Personalized-Coaching Interventions

Intervention Type: BEHAVIORAL

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.

Motivational Messages

Intervention Type: BEHAVIORAL

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.

Online Exercise Tutorials

Intervention Type: BEHAVIORAL

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

Social Support and Peer Challenges

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Mogayzel, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

IRB00055571

Identifier Type: -

Identifier Source: org_study_id