ActivOnline: Physical Activity in Cystic Fibrosis Trial UK

Cystic Fibrosis Clinical Trial

— ActiOnPACTUK  

Official title:

A Randomised Controlled Trial of a Novel Web-based Intervention to Promote Physical Activity Participation in People With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249999
• Other study ID #: 1819/04
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: July 2022

Study information

• Verified date: July 2021
• Source: University of Exeter
• Contact: Owen W Tomlinson, PhD
• Phone: +44(0)1392727049
• Email: o.w.tomlinson[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: July 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• ActivOnline
Access to online physical activity platform (www.activonline.com.au)

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter	Devon

Sponsors (4)

Lead Sponsor	Collaborator
University of Exeter	Cystic Fibrosis Trust, Monash University, Sport England

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative assessment of barriers and facilitators to physical activity	Semi-structured, 10-item interview for participants in both intervention and control group	3-months post-intervention (+24 weeks)
Other	Qualitative assessment of Activ Online programme	Semi-structured interview question for participants assigned to intervention group	3-months post-intervention (+24 weeks)
Other	Usage of Activ Online programme	Frequency of access and logging of physical activity data	Post-intervention (+12 weeks)
Other	Changes in physical activity, measured by Sport England Short Active Lives Survey.	Subjective assessment of physical activity	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks)
Other	Changes in physical activity, measured by Sport England Engagement in Sport Questions	Subjective assessment of physical activity	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks)
Primary	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.	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Primary	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.	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)	Assessment of lung function	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	Change in forced vital capacity (FVC), measured in absolute units (L)	Assessment of lung function	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.	Assessment of lung function	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	Change in forced vital capacity (FVC), measured as a percent of predicted, as per GLI2012 equations.	Assessment of lung function	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).
Secondary	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).	Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).