ActivOnline: Physical Activity in Cystic Fibrosis Trial UK

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: ActivOnline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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). |