Do More, B'More, Live Fit

NCT03109912 | Completed

• 1 other identifier: IRB00055571
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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. 1.Increase daily PA and measures of fitness
2. 2.Improve lung clearance index (LCI) and participant HRQoL
3. 3.Demonstrate feasibility, accessibility and satisfaction of intervention using semi-structured interviews

Conditions

Cystic Fibrosis; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0)

  LCI is measured via multiple breath washout (MBW) using a device called the EXHALYZER D. MBW is a non-invasive test that measures how difficult it is for air to leave the lungs and currently, the use of the EXHALYZER D is investigational. For MBW, participants breathe oxygen for about 3-5 minutes using a mouthpiece and normal breathing without any special breathing maneuvers.

  Change from baseline at 6-months

• Daily activity via FitBit Step Count

  Daily step count (mean, median and highest daily) recorded through participant FitBit flex

  Change from baseline at 6-months

Secondary Outcomes (5)

• Pulmonary function testing (FEV1)

  Change from baseline at 6-months

• Self-reported daily activity via the Habitual Activity Estimation Scale (HAES)

  Change from baseline at 6-months

• Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)

  Change from baseline at 6-months

• Exercise capacity via Modified Shuttle Walk Test (MSWT)

  Change from baseline at 6-months

• Semi-structured interview

  Change from baseline at 6-months

Study Arms (2)

Control

NO INTERVENTION

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

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.

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

Interventions

Personalized-Coaching Interventions 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.

Exercise Intervention

Motivational Messages 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.

Exercise Intervention

Online Exercise Tutorials BEHAVIORAL

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

Exercise Intervention

Social Support and Peer Challenges 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.

Exercise Intervention

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Peter Mogayzel, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 12, 2017
• Study Start: June 17, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04