Cystic FibrosisActiOnPACTUKNCT04249999
ActivOnline: Physical Activity in Cystic Fibrosis Trial UK
A study testing ActivOnline in people with Cystic Fibrosis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Increased level of physical activity (PA) are of benefit in the management of cystic fibrosis (CF). This randomised control tial will assess whether three-months use of an online platform can help increase PA levels in people with CF (compared to a control group continuing routine treatment). Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- ActivOnline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2020to 1 Sep 2021
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of CF
- Aged 12-35 years (inclusive)
- Able to provide informed consent/assent
- Able to access the internet via computer or mobile device
Who cannot join
- Presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. orthopaedic, cardiac or neurological condition)
- Previous lung transplantation
- Pregnancy
- Unable to provide informed consent/assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of a Novel Web-based Intervention to Promote Physical Activity Participation in People With Cystic Fibrosis
Increased level of physical activity (PA) are of benefit in the management of cystic fibrosis (CF). This randomised control tial will assess whether three-months use of an online platform can help increase PA levels in people with CF (compared to a control group continuing routine treatment).
Read the detailed description
Cystic fibrosis (CF) is a genetic condition that predominantly affects the lungs through an accumulation of thick mucus. As there is no cure for CF, it is a disease that is managed through intensive medication, nutrition, physiotherapy, exercise and physical activity (PA).
Increased levels of PA are of benefit to people with CF, and therefore interventions that promote PA are warranted, particularly in adolescence, whereby PA levels decrease. Telehealth interventions are of particular interest in CF, whereby strict cross-infection guidelines prevent patients meeting in person, and allowing patients to overcome geographical barriers at the same time.
Previous research has shown engagement with an online platform (www.activonline.com.au), specifically designed to monitor PA in CF, is feasible and acceptable to people with CF. Therefore, a full randomised control trial is warranted to assess the efficacy of this intervention in changing PA.
UPDATE JUNE 2021: Due to ongoing restrictions placed upon research by the global COVID-19 pandemic, modifications to the protocol are necessary.
Recruitment and consenting will now take place online, and testing procedures will be completed by participants in their own homes. The nature, and length of, intervention remains unchanged.
Changes to protocol approved by ethics board on May 4th 2021.
- Conditions
- Cystic Fibrosis
- Being tested
- ActivOnline
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivOnlineBehavioural
Access to online physical activity platform (www.activonline.com.au)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to online physical activity platform (www.activonline.com.au) in addition to usual care. Receives: Behavioral: ActivOnline |
| Control | No intervention | No access to online physical activity platform. Continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity, objectively measures using ActiGrpah GT9X Link accelerometer.
Time spent in sedentary, light, moderate and vigorous physical activity domains will be assessed over a one week period. Accelerometer to be worn on non-dominant wrist.
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.
Questionnaire determines time spent being inactive, somewhat inactive, somewhat active and very active, each reported as a percentage of the day.
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary outcomes (10)
Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)
Assessment of lung function
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced vital capacity (FVC), measured in absolute units (L)
Assessment of lung function
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.
Assessment of lung function
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced vital capacity (FVC), measured as a percent of predicted, as per GLI2012 equations.
Assessment of lung function
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in exercise attitudes, measured using the Behavioural Regulation in Exercise Questionnaire.
Assessment of reasons underlying people's decision to engage, or not engage, in exercise. Scores range from -24 to +20, where a higher score indicates greater exercise autonomy (better outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in quality of life, measured using age-specific Cystic Fibrosis Questionnaire (Revised).
Subjective assessment of health related quality of life, scored from 0 to 100 where a higher score indicates higher quality of life (better outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in anxiety, measured using Hospital Anxiety and Depression Scale.
Subjective report of anxiety, scored from 0 to 21, where a higher score indicates higher anxiety (worse outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in depression, measured using Hospital Anxiety and Depression Scale.
Subjective report of depression, scored from 0 to 21, where a higher score indicates higher depression (worse outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in depression, measured using Center for Epidemiological Studies-Depression Scale.
Subjective reports of anxiety and depression, scored from 0 to 60 where a higher score indicates greater depressive symptoms (worse outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in sleep quality, measured using Pittsburgh Sleep Quality Index (PSQI).
Subjective report of sleep quality, scored from 0 to 21 where a higher score indicates worse sleep quality (worse outcome).
Measured: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start7 May 2020
- Primary completionSep 2021 (estimated)
- Study completion1 Sep 2021
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Trust, Sport England, Monash University
- Responsible party
- Sponsor
- Investigators
- Craig A Williams, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249999
- Sponsor's protocol ID
- 1819/04
- Acronym
- ActiOnPACTUK
- Status last verified
- Sep 2024
- First submitted
- 13 Nov 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.
PubMed 25425703Cox NS, Eldridge B, Rawlings S, Dreger J, Corda J, Hauser J, Button BM, Bishop J, Nichols A, Middleton A, Ward N, Dwyer T, Tomlinson OW, Denford S, Barker AR, Williams CA, Kingsley M, O'Halloran P, Holland AE; Youth Activity Unlimited - A Strategic Research Centre of the UK Cystic Fibrosis Trust. A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: protocol for a randomized controlled trial. BMC Pulm Med. 2019 Dec 19;19(1):253. doi: 10.1186/s12890-019-0942-3.
PubMed 31856791Tomlinson OW, Barker AR, Denford S, Williams CA. Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic upon research in a clinical population. Contemp Clin Trials Commun. 2024 Mar 27;39:101294. doi: 10.1016/j.conctc.2024.101294. eCollection 2024 Jun.
PubMed 38577655
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Novel Web-based Intervention to Promote Physical Activity Participation in People With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04249999
- Acronym / sponsor ID
- ActiOnPACTUK / 1819/04
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Trust, Sport England, Monash University
- Study start
- 7 May 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 31 Jan 2020 (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.
Increased level of physical activity (PA) are of benefit in the management of cystic fibrosis (CF). This randomised control tial will assess whether three-months use of an online platform can help increase PA levels in people with CF (compared to a control group continuing routine treatment).
Detailed description
Cystic fibrosis (CF) is a genetic condition that predominantly affects the lungs through an accumulation of thick mucus. As there is no cure for CF, it is a disease that is managed through intensive medication, nutrition, physiotherapy, exercise and physical activity (PA).
Increased levels of PA are of benefit to people with CF, and therefore interventions that promote PA are warranted, particularly in adolescence, whereby PA levels decrease. Telehealth interventions are of particular interest in CF, whereby strict cross-infection guidelines prevent patients meeting in person, and allowing patients to overcome geographical barriers at the same time.
Previous research has shown engagement with an online platform (www.activonline.com.au), specifically designed to monitor PA in CF, is feasible and acceptable to people with CF. Therefore, a full randomised control trial is warranted to assess the efficacy of this intervention in changing PA.
UPDATE JUNE 2021: Due to ongoing restrictions placed upon research by the global COVID-19 pandemic, modifications to the protocol are necessary.
Recruitment and consenting will now take place online, and testing procedures will be completed by participants in their own homes. The nature, and length of, intervention remains unchanged.
Changes to protocol approved by ethics board on May 4th 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ActivOnlineAccess to online physical activity platform (www.activonline.com.au) in addition to usual care. |
| Control | No intervention | –No access to online physical activity platform. Continue with usual care. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of CF
- Aged 12-35 years (inclusive)
- Able to provide informed consent/assent
- Able to access the internet via computer or mobile device
Key exclusion criteria (4 listed)
- Presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. orthopaedic, cardiac or neurological condition)
- Previous lung transplantation
- Pregnancy
- Unable to provide informed consent/assent
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 |
|---|---|---|
| ActivOnlineAccess to online physical activity platform (www.activonline.com.au) | Behavioural | Intervention |
Primary outcome
Change in physical activity, objectively measures using ActiGrpah GT9X Link accelerometer.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Time spent in sedentary, light, moderate and vigorous physical activity domains will be assessed over a one week period. Accelerometer to be worn on non-dominant wrist.
Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Questionnaire determines time spent being inactive, somewhat inactive, somewhat active and very active, each reported as a percentage of the day.
10 secondary outcomes
Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced vital capacity (FVC), measured in absolute units (L)
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in forced vital capacity (FVC), measured as a percent of predicted, as per GLI2012 equations.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in exercise attitudes, measured using the Behavioural Regulation in Exercise Questionnaire.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in quality of life, measured using age-specific Cystic Fibrosis Questionnaire (Revised).
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in anxiety, measured using Hospital Anxiety and Depression Scale.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in depression, measured using Hospital Anxiety and Depression Scale.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in depression, measured using Center for Epidemiological Studies-Depression Scale.
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Change in sleep quality, measured using Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25425703Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.
- Background: PubMed 31856791Cox NS, Eldridge B, Rawlings S, Dreger J, Corda J, Hauser J, Button BM, Bishop J, Nichols A, Middleton A, Ward N, Dwyer T, Tomlinson OW, Denford S, Barker AR, Williams CA, Kingsley M, O'Halloran P, Holland AE; Youth Activity Unlimited - A Strategic Research Centre of the UK Cystic Fibrosis Trust. A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: protocol for a randomized controlled trial. BMC Pulm Med. 2019 Dec 19;19(1):253. doi: 10.1186/s12890-019-0942-3.
- Results publication: PubMed 38577655Tomlinson OW, Barker AR, Denford S, Williams CA. Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic upon research in a clinical population. Contemp Clin Trials Commun. 2024 Mar 27;39:101294. doi: 10.1016/j.conctc.2024.101294. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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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.
Craig A Williams, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivOnline in people with Cystic Fibrosis, run by University of Exeter at 1 site in United Kingdom.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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 physical activity, objectively measures using ActiGrpah GT9X Link accelerometer. (time frame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).). 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?
On the ClinicalTrials.gov record for NCT04249999, which also lists 3 linked publications.
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 19 Sep 2024.