A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weekly minutes of moderate-vigorous physical activity
研究概览
简要总结
With advances in genetic therapies, many people with Cystic Fibrosis (CF) are living longer. With the improvement in life expectancy has emerged an increased risk of cardiovascular disease (CVD). Factors such as insulin resistance, reduced physical activity, rising blood pressure from newer medications, and changes in body mass index have made cardiovascular health a growing concern in CF care.
This study aims to assess whether a remotely delivered, monitored exercise programme can increase physical activity levels in adults with CF. Secondary outcomes will explore whether the intervention improves key CVD risk factors. Participants will be randomly assigned to either a control group or an intervention group, which will complete an 8-week home-based aerobic and resistance exercise programme. Exercise intensity will be tailored using the Rate of Perceived Exertion scale.
Key outcomes include weekly physical activity levels, body mass index, waist circumference, lung function (spirometry) and blood biomarkers. Home-based capillary blood tests, analysed pre- and post-intervention, will measure cholesterol, lipid profiles, inflammation and other relevant hormones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Past diagnosis of Cystic Fibrosis confirmed via two copies of a faulty CFTR gene, or; previous sweat chloride test with a result >60mmol/L chloride, or; prescribed modulator therapy (Orkambi, Symkevi, Kaftrio);
排除标准
- •Any reported condition, behaviour or reported use of substances which may pose undue personal risk to the participant or introduce bias into the study, except for any which are ubiquitous in society and so would be equally distributed between groups and/or therefore relevant to generalisation (e.g. caffeine)
- •Medications which increase risk of harm to a participant exercising remotely such as fluoroquinolone antibiotics, beta blockers, or blood pressure medication
- •Individuals with unstable or poorly controlled diabetes
- •Individuals on statins
- •Females who are pregnant or lactating
- •Individuals with a previous self-reported history of an eating disorder
- •Individuals unable to provide informed consent e.g. inability to read or speak English
- •Individuals who are not weight stable (i.e. >3kg change in body mass in the past 3 months)
- •Individuals awaiting a solid organ transplant, have a diagnosis of pulmonary hypertension or require long term oxygen therapy to exercise at home
- •Individuals with chest pain, dizziness or loss of consciousness during exercise, who have been instructed by a doctor to only do certain types/quantity of physical activity
- •Individuals on any current ongoing medication or treatment for injuries or illness which impact on their ability to do physical tasks or exercises
- •Individuals who are PAR-Q positive response during screening
结局指标
主要结局
Weekly minutes of moderate-vigorous physical activity
时间窗: Baseline and 8 weeks
Measured using a Geneactiv wrist-based activity monitor
次要结局
- Body mass index(Baseline and 8 weeks)
- Waist circumference(Baseline and 8 weeks)
- Waist to hip ratio(Baseline and 8 weeks)
- 1-minute sit to stand test(Baseline and 8 weeks)
- Multidimensional Fatigue Inventory(Baseline and 8 weeks)
- Cystic Fibrosis Questionnaire Revised(Baseline and 8 weeks)
- Manchester Musculoskeletal Screening tool(Baseline and 8 weeks)
- Sleep quality(Baseline and 8 weeks)
- Fasting insulin levels, pmol/L(Baseline and 8 weeks)
- Fasting triglyceride concentration, mmol/L(Baseline and 8 weeks)
- Serum fructosamine, mmol/L(Baseline and 8 weeks)
- Fasting LDL-C, HDL-C and total cholesterol, mmol/L(Baseline and 8 weeks)
- High sensitivity C-reactive protein, mg/L(Baseline and 8 weeks)
- Forced expiratory volume in one second(Baseline and 8 weeks)
- Forced Vital Capacity(Baseline and 8 weeks)
研究者
Rachel McDowell
GW4-CAT PhD Programme for Health Professionals PhD Programme Fellow
University of Bath