ActivOnline: Physical Activity in Cystic Fibrosis Trial UK (ActiOnPACTUK)

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).

Study Overview

• Status: Withdrawn
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: ActivOnline

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Access to online physical activity platform (www.activonline.com.au) in addition to usual care.	Behavioral: ActivOnline; Access to online physical activity platform (www.activonline.com.au)
No Intervention: Control; No access to online physical activity platform. Continue with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Qualitative assessment of Activ Online programme	Semi-structured interview question for participants assigned to intervention group	3-months post-intervention (+24 weeks)
Usage of Activ Online programme	Frequency of access and logging of physical activity data	Post-intervention (+12 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: Monash University; Cystic Fibrosis Trust; Sport England
• Investigators: Principal Investigator: Craig A Williams, PhD, University of Exeter

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Estimated): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 1819/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No