Clinical trial NCT04249999: ActivOnline: Physical Activity in Cystic Fibrosis Trial UK
Official title: A Randomised Controlled Trial of a Novel Web-based Intervention to Promote Physical Activity Participation in People With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Trust
name: Sport England
name: Monash University
First posted: 2020-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in physical activity, objectively measures using ActiGrpah GT9X Link accelerometer.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary outcomes:
measure: Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in forced vital capacity (FVC), measured in absolute units (L)
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in forced vital capacity (FVC), measured as a percent of predicted, as per GLI2012 equations.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in exercise attitudes, measured using the Behavioural Regulation in Exercise Questionnaire.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in quality of life, measured using age-specific Cystic Fibrosis Questionnaire (Revised).
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in anxiety, measured using Hospital Anxiety and Depression Scale.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in depression, measured using Hospital Anxiety and Depression Scale.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in depression, measured using Center for Epidemiological Studies-Depression Scale.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
measure: Change in sleep quality, measured using Pittsburgh Sleep Quality Index (PSQI).
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Other outcomes:
measure: Qualitative assessment of barriers and facilitators to physical activity
timeFrame: 3-months post-intervention (+24 weeks)
measure: Qualitative assessment of Activ Online programme
timeFrame: 3-months post-intervention (+24 weeks)
measure: Usage of Activ Online programme
timeFrame: Post-intervention (+12 weeks)
measure: Changes in physical activity, measured by Sport England Short Active Lives Survey.
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks)
measure: Changes in physical activity, measured by Sport England Engagement in Sport Questions
timeFrame: Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks)
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Craig A Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cox 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.
citation: Tomlinson 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.