Feasibility of providing digital physical activity promotion materials for young people with cystic fibrosis

Feasibility randomised controlled trial of digital physical activity promotion materials for young people with Cystic Fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21222766

Enrollment

Registered

2022-11-07

Start date

2022-10-24

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Respiratory

Interventions

The study design is a two-arm feasibility randomised controlled trial with nested mixed-methods process evaluation. Participants will be randomly allocated in a 1:1 ratio to receive one of two types o

(2) health-related quality of life

(3) physical activity behaviour

and (4) health and social care resource use and economic impact. All participants will also be required to wear an activity monitor for a period of 7-days, alongside completing a short log about their

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of cystic fibrosis 2. Aged between 12 and 18 years old 3. Able to access the internet via any electronic device

Exclusion criteria

Exclusion criteria: 1. Presence of an existing severe co-morbidity limiting mobilisation and/or participation in physical activity (e.g., orthopaedic, cardiac, or neurological condition) 2. Current (i.e., within the last month) lung function (forced expiratory volume in one second) is below 40% predicted 3. Currently pregnant 4. Inability to understand verbal and/or written English 5. Participation in a concurrent study for which eligibility precludes them from engaging in another research study and/or study focused on physical activity 6. Participation in a Patient and Public Involvement Advisory Group and/or research study that has directly informed the design of the present feasibility trial

Design outcomes

Primary

Measure	Time frame
Feasibility of enrolling participants measured using patient logs throughout the trial: 1. The average number of participants enrolled into the trial per month, including details of their recruitment pathway/route 2. The eligible population, as indicated by the number of eligible participants invited 3. Recruitment (where possible), indicated by the number of participants who submit an Expression of Interest 4. Enrolment/uptake, indicated by the number of participants enrolled	—

Measure

Time frame

Feasibility of enrolling participants measured using patient logs throughout the trial: 1. The average number of participants enrolled into the trial per month, including details of their recruitment pathway/route 2. The eligible population, as indicated by the number of eligible participants invited 3. Recruitment (where possible), indicated by the number of participants who submit an Expression of Interest 4. Enrolment/uptake, indicated by the number of participants enrolled

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Secondary

Measure	Time frame
1. Retention rates measured using a Trial Process Log throughout the 6-month trial recruitment and follow-up data collection periods 2. Trial assessment completion rates measured as part of the Trial Process Log for each participant at each of the trial data collection timepoints 3. Drop-out rates measured using a Trial Process Log throughout the 6-month trial recruitment and follow-up data collection periods 4. Usage of digital physical activity promotion materials measured using online metrics (e.g., total time spent using digital physical activity materials) throughout the 6-month follow-up data collection period 5. Feasibility of use and trial satisfaction measured using the User Version of the Mobile Application Rating Scale (uMARS) questionnaire after 1-month follow-up and qualitative interviews after 1-month and 6-months of follow-up in a sub-sample of participants. Trial satisfaction will also be recorded via the Trial Satisfaction Questionnaire (at 6-month follow-up) or Trial Withdrawal Questionnaire (at the point of trial withdrawal). 6. Describing usual care in relation to physical activity will be measured by the completion of an online form by each participant’s CF Care Team at the baseline data collection timepoint	—

Measure

Time frame

1. Retention rates measured using a Trial Process Log throughout the 6-month trial recruitment and follow-up data collection periods 2. Trial assessment completion rates measured as part of the Trial Process Log for each participant at each of the trial data collection timepoints 3. Drop-out rates measured using a Trial Process Log throughout the 6-month trial recruitment and follow-up data collection periods 4. Usage of digital physical activity promotion materials measured using online metrics (e.g., total time spent using digital physical activity materials) throughout the 6-month follow-up data collection period 5. Feasibility of use and trial satisfaction measured using the User Version of the Mobile Application Rating Scale (uMARS) questionnaire after 1-month follow-up and qualitative interviews after 1-month and 6-months of follow-up in a sub-sample of participants. Trial satisfaction will also be recorded via the Trial Satisfaction Questionnaire (at 6-month follow-up) or Trial Withdrawal Questionnaire (at the point of trial withdrawal). 6. Describing usual care in relation to physical activity will be measured by the completion of an online form by each participant’s CF Care Team at the baseline data collection timepoint

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026