A Randomised Controlled Trial of a Novel Web-based Intervention to Promote Physical Activity Participation in People With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Physical activity intervention. Assignment to intervention or control group cannot be blinded.
Follow-up assessments will be conducted by blinded assessors.
UPADTE JUNE 2021: As noted in update above, all participants will perform procedures themselves within their own homes (i.e. physical activity, lung function, questionnaires). Therefore, use of blinded assessors is no longer applicable.
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.
时间窗: 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.
Change in physical activity, objectively measures using ActiGrpah GT9X Link accelerometer.
时间窗: 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.
次要结局
- Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in sleep quality, measured using Pittsburgh Sleep Quality Index (PSQI).(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in depression, measured using Hospital Anxiety and Depression Scale.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in quality of life, measured using age-specific Cystic Fibrosis Questionnaire (Revised).(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in anxiety, measured using Hospital Anxiety and Depression Scale.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in forced vital capacity (FVC), measured in absolute units (L)(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.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in exercise attitudes, measured using the Behavioural Regulation in Exercise Questionnaire.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)
- Change in depression, measured using Center for Epidemiological Studies-Depression Scale.(Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).)