Cystic FibrosisNCT03109912
Do More, B'More, Live Fit
A study testing Personalized-Coaching Interventions, Motivational Messages and Online Exercise Tutorials in people with Cystic Fibrosis and Physical Activity, run by Johns Hopkins University.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Cystic Fibrosis, Physical Activity
- What is being tested?
- Personalized-Coaching Interventions, Motivational Messages and Online Exercise Tutorials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2015to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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:
Read more
- Increase daily PA and measures of fitness
- Improve lung clearance index (LCI) and participant HRQoL
- 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
- Being tested
- Personalized-Coaching Interventions, Motivational Messages, Online Exercise Tutorials, Social Support and Peer Challenges
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized-Coaching InterventionsBehavioural
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 MessagesBehavioural
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 TutorialsBehavioural
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 ChallengesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalized-Coaching Interventions; Behavioral: Motivational Messages; Behavioral: Online Exercise Tutorials; Behavioral: Social Support and Peer Challenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline at 6-months
Secondary outcomes (5)
Pulmonary function testing (FEV1)
Spirometry is obtained for FEV1 percent predicted
Measured: Change from baseline at 6-months
Self-reported daily activity via the Habitual Activity Estimation Scale (HAES)
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.
Measured: Change from baseline at 6-months
Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)
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.
Measured: Change from baseline at 6-months
Exercise capacity via Modified Shuttle Walk Test (MSWT)
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.
Measured: Change from baseline at 6-months
Semi-structured interview
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.
Measured: Change from baseline at 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start17 Jun 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Mogayzel, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109912
- Sponsor's protocol ID
- IRB00055571
- Status last verified
- Apr 2017
- First submitted
- 22 Feb 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03109912
- Acronym / sponsor ID
- IRB00055571
- Conditions
- Cystic Fibrosis, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 17 Jun 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increase daily PA and measures of fitness
- Improve lung clearance index (LCI) and participant HRQoL
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Personalized-Coaching Interventions, Behavioral: Motivational Messages, Behavioral: Online Exercise Tutorials, Behavioral: Social Support and Peer ChallengesThe 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. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized-Coaching InterventionsAt 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. | Behavioural | Exercise Intervention |
| Motivational MessagesIntervention 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. | Behavioural | Exercise Intervention |
| Online Exercise TutorialsParticipants are given access to Do More, B'More, Live Fit webpage which includes spotlighted exercises, instructional exercise photos and videos. | Behavioural | Exercise Intervention |
| Social Support and Peer ChallengesParticipants 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. | Behavioural | Exercise Intervention |
Primary outcome
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.
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
5 secondary outcomes
Pulmonary function testing (FEV1)
Time frame: 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
Health-related Quality of Life (HRQoL) via Cystic Fibrosis Questionnaire- Revised (CFQ-R)
Time frame: Change from baseline at 6-months
Exercise capacity via Modified Shuttle Walk Test (MSWT)
Time frame: Change from baseline at 6-months
Semi-structured interview
Time frame: Change from baseline at 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Mogayzel, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Personalized-Coaching Interventions, Motivational Messages and Online Exercise Tutorials in people with Cystic Fibrosis and Physical Activity, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function testing (Lung clearance index: LCI 2.5 and LCI 5.0) (time frame: Change from baseline at 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.