Cystic FibrosisNCT03672058
Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
A study testing Fitness tracker with goal setting and text message feedback and Fitness Tracker only in people with Cystic Fibrosis, run by University of Limerick at 1 site in Ireland.
Trial summary
Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Fitness tracker with goal setting and text message feedback and Fitness Tracker only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2018to 28 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable CF patients
- Age > 18 years
- Confirmed diagnosis of CF
- Access to a smartphone/tablet to access and upload to Fitbit Application.
- Capacity and willingness to give explicit informed consent
Who cannot join
- FEV1 < 25%.
- Patients on the waiting list for lung transplantation and those who have undergone lung transplantation.
- Patients with an exacerbation in the four weeks prior to the study. For the purpose of this study pulmonary exacerbation will be defined as acute or subacute worsening of respiratory symptoms which warrant change in treatment (i.e., new oral or intravenous antibiotics). Patients can undergo testing once they are finished their antibiotics and deemed clinically stable.
- Patients dependent on supplemental oxygen for exercise.
- Pregnancy
- Participation in another clinical trial up to 4 weeks prior to the first baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity.
The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date.
Read more
The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes.
Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist.
Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of <70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with <30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred.
Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks.
The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists.
The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks.
Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.
- Conditions
- Cystic Fibrosis
- Being tested
- Fitness tracker with goal setting and text message feedback, Fitness Tracker only
- Keywords
- Cystic Fibrosis, CF
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness tracker with goal setting and text message feedbackOther
Participants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant.
Fitness Tracker onlyOther
Participants will be provided with the Fitbit and educated on how to use it. This will be linked to "Fitabase", an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels
| Study group | Role | What they receive |
|---|---|---|
| Fitbit plus personalised text messaging & Goal Setting | Experimental | Not described Receives: Other: Fitness tracker with goal setting and text message feedback |
| Fitbit Only | Active comparator | Not described Receives: Other: Fitness Tracker only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in 1 second (FEV1) (%predicted)
Spirometry
Measured: Baseline to 3 months and Baseline to 6 months
Change in peak oxygen uptake (% predicted)
Cardiopulmonary Exercise Testing
Measured: Baseline to 3 months and Baseline to 6 months
Change in number of steps per day
Fitbit/Activpal
Measured: Baseline to 3 months and Baseline to 6 months
Secondary outcomes (12)
Change in maximal aerobic power (%predicted)
Cardiopulmonary Exercise Testing
Measured: Baseline to 3 months and Baseline to 6 months
Change in forced expiratory volume (FVC) (%predicted)
Spirometry
Measured: Baseline to 3 months and Baseline to 6 months
Change in grip strength
Hand Dynamometry
Measured: Baseline to 3 months and Baseline to 6 months
Change in body mass index (kg/m2)
SECA Medical Body Composition Analyser
Measured: Baseline to 3 months and Baseline to 6 months
Change in muscle mass (kg)
SECA Medical Body Composition Analyser
Measured: Baseline to 3 months and Baseline to 6 months
Change in percent body fat
SECA Medical Body Composition Analyser
Measured: Baseline to 3 months and Baseline to 6 months
Change in Cystic Fibrosis Quality of Life Scale (CFQR)
Measurement of the quality of life by the Cystic Fibrosis Questionnaire Revised (CFQ-R, Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions. Symptom scales: Weight, respiratory, and digestion). There are 5 distinct 4-point Likert scale. Scores range from 0 to 100, with higher scores indicating better health.
Measured: Baseline to 3 months and Baseline to 6 months
Change in self reported physical activity (International Physical Activity Questionnaire Short Form)
International Physical Activity Questionnaire. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. It assesses 7 items to get a global score and then categorizes physical activity into low, moderate or high.
Measured: Baseline to 3 months and Baseline to 6 months
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Baseline to 3 months and Baseline to 6 months
The University of California San Diego (UCSD) Shortness of Breath Questionnaire
To assess dyspnea associated with activities of daily living (ADLs). There are 24 items on this questionnaire. Each item is assessed on a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness"). Scores range from 0 to 120 with higher scores indicating activities of daily living are extremely limited by shortness of breath.
Measured: Baseline to 3 months and Baseline to 6 months
Change in wellbeing
Alfred Wellness Score. This questionnaire assesses state of wellness to assist in providing best health care. There are 10 questions which are scored from 0-10. 10 reflects most well state of being possible while zero reflects least well state. Scores range from 0-100 with higher scores indicating good state of wellness.
Measured: Baseline to 3 months and Baseline to 6 months
Change in number of minutes spent in moderate to vigorous physical activity (MVPA)
Fitbit/Activpal
Measured: Baseline to 3 months and Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Oct 2018
- Primary completion28 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roisin Cahalan, PhD, Principal investigator, University of LimerickAudrey Tierney, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672058
- Sponsor's protocol ID
- CF UHL UL
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2018
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Curran M, Tierney AC, Collins L, Kennedy L, McDonnell C, Jurascheck AJ, Sheikhi A, Walsh C, Button B, Galvin R, Casserly B, Cahalan R. Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocol for a pilot randomised trial using wearable technology, goal setting and text message feedback. HRB Open Res. 2020 Nov 16;3:21. doi: 10.12688/hrbopenres.13025.3. eCollection 2020.
PubMed 33283151
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03672058
- Acronym / sponsor ID
- CF UHL UL
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, CF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 14 Sep 2018 (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 is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity.
The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date.
The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes.
Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist.
Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of <70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with <30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred.
Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks.
The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists.
The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks.
Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit plus personalised text messaging & Goal Setting | Experimental | Other: Fitness tracker with goal setting and text message feedback |
| Fitbit Only | Active comparator | Other: Fitness Tracker only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically stable CF patients
- Age > 18 years
- Confirmed diagnosis of CF
- Access to a smartphone/tablet to access and upload to Fitbit Application.
- Capacity and willingness to give explicit informed consent
Key exclusion criteria (6 listed)
- FEV1 < 25%.
- Patients on the waiting list for lung transplantation and those who have undergone lung transplantation.
- Patients with an exacerbation in the four weeks prior to the study. For the purpose of this study pulmonary exacerbation will be defined as acute or subacute worsening of respiratory symptoms which warrant change in treatment (i.e., new oral or intravenous antibiotics). Patients can undergo testing once they are finished their antibiotics and deemed clinically stable.
- Patients dependent on supplemental oxygen for exercise.
- Pregnancy
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 |
|---|---|---|
| Fitness tracker with goal setting and text message feedbackParticipants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant. | Other | Fitbit plus personalised text messaging & Goal Setting |
| Fitness Tracker onlyParticipants will be provided with the Fitbit and educated on how to use it. This will be linked to "Fitabase", an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels | Other | Fitbit Only |
Primary outcome
Change in forced expiratory volume in 1 second (FEV1) (%predicted)
Time frame: Baseline to 3 months and Baseline to 6 months
Spirometry
Change in peak oxygen uptake (% predicted)
Time frame: Baseline to 3 months and Baseline to 6 months
Cardiopulmonary Exercise Testing
Change in number of steps per day
Time frame: Baseline to 3 months and Baseline to 6 months
Fitbit/Activpal
12 secondary outcomes
Change in maximal aerobic power (%predicted)
Time frame: Baseline to 3 months and Baseline to 6 months
Change in forced expiratory volume (FVC) (%predicted)
Time frame: Baseline to 3 months and Baseline to 6 months
Change in grip strength
Time frame: Baseline to 3 months and Baseline to 6 months
Change in body mass index (kg/m2)
Time frame: Baseline to 3 months and Baseline to 6 months
Change in muscle mass (kg)
Time frame: Baseline to 3 months and Baseline to 6 months
Change in percent body fat
Time frame: Baseline to 3 months and Baseline to 6 months
Change in Cystic Fibrosis Quality of Life Scale (CFQR)
Time frame: Baseline to 3 months and Baseline to 6 months
Change in self reported physical activity (International Physical Activity Questionnaire Short Form)
Time frame: Baseline to 3 months and Baseline to 6 months
Pittsburgh Sleep Quality Index
Time frame: Baseline to 3 months and Baseline to 6 months
The University of California San Diego (UCSD) Shortness of Breath Questionnaire
Time frame: Baseline to 3 months and Baseline to 6 months
Change in wellbeing
Time frame: Baseline to 3 months and Baseline to 6 months
Change in number of minutes spent in moderate to vigorous physical activity (MVPA)
Time frame: Baseline to 3 months and Baseline to 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 30 Jan 2025.
- Derived from this study: PubMed 33283151Curran M, Tierney AC, Collins L, Kennedy L, McDonnell C, Jurascheck AJ, Sheikhi A, Walsh C, Button B, Galvin R, Casserly B, Cahalan R. Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocol for a pilot randomised trial using wearable technology, goal setting and text message feedback. HRB Open Res. 2020 Nov 16;3:21. doi: 10.12688/hrbopenres.13025.3. eCollection 2020.
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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.
Roisin Cahalan, PhD principal investigator
University of Limerick
Audrey Tierney, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness tracker with goal setting and text message feedback and Fitness Tracker only in people with Cystic Fibrosis, run by University of Limerick at 1 site in Ireland.
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 5 inclusion and 6 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in forced expiratory volume in 1 second (FEV1) (%predicted) (time frame: Baseline to 3 months and Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672058, which also lists 1 linked publication.
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 30 Jan 2025.