Do More, B'More, Live Fit

April 6, 2017 updated by: Johns Hopkins University

Do More, B'More, Live Fit: An Outpatient Fitness-training Pilot Program Designed to Optimize the Habit of Exercise in Adolescents and Young Adults With Cystic Fibrosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0)
Time Frame: Change from baseline at 6-months
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
Time Frame: Change from baseline at 6-months
Daily step count (mean, median and highest daily) recorded through participant FitBit flex
Change from baseline at 6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary function testing (FEV1)
Time Frame: Change from baseline at 6-months
Spirometry is obtained for FEV1 percent predicted
Change from baseline at 6-months
Self-reported daily activity via the Habitual Activity Estimation Scale (HAES)
Time Frame: Change from baseline at 6-months
Self-reported activity will be measured via the HAES. The HAES is a questionnaire that measures self-reported light, moderate or strenuous activity for weekday and weekend activities. The HAES is a reliable and valid instrument in the pediatric and adult CF patient populations. Habitual activity will be recorded as a percentage of time when the participant was awake and performing light, moderate, and vigorous aerobic physical activity, strengthening and/or stretching exercises.
Change from baseline at 6-months
Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)
Time Frame: Change from baseline at 6-months
The CFQ-R, a HRQoL measure for people with CF that measures symptoms and treatment burden. It is a validated instrument for CF patients that scores QoL in 12 general domains, will be administered to assess the participant's HRQoL at baseline and 6-months from intervention onset. Scores for each domain will be expressed on a scale of 0-100.
Change from baseline at 6-months
Exercise capacity via Modified Shuttle Walk Test (MSWT)
Time Frame: Change from baseline at 6-months
For the MSWT, participants are asked to walk 10-meter sets at a faster and faster speed until they are unable to continue to keep up with the increased speed or have symptoms including fatigue, dyspnea, chest pain that prevent them from continuing. It is a validated field test of exercise capacity in pediatric CF patients in which the participant walks shuttles of 10-meters in length at a progressively increasing pace. The number of shuttles completed will be recorded at baseline and 6-months from enrollment. Comparisons will be made between cohorts and between participant change from baseline to study conclusion at 6-months.
Change from baseline at 6-months
Semi-structured interview
Time Frame: Change from baseline at 6-months
30-minute survey at follow-up 6-month appointments to assess acceptability and feasibility of the exercise interventions. Conducted by study team members with the participant and parent together, the one-time survey includes themes on intervention burden, benefits and/or concerns with interventions, willingness to continue interventions, suggestions to make interventions more feasible for regular use, perception of behavior change and technical challenges with interventions.
Change from baseline at 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Mogayzel, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00055571

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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