Cardiovascular Disease Risk Factors, Cystic Fibrosis (CF)
Conditions
Keywords
Exercise, Physical activity, Cystic Fibrosis, Cardiovascular disease risk, Mobile health interventions
Brief summary
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.
Interventions
BEHAVIORALMobile health exercise programme
8 week personalised exercise intervention. Delivered and monitored via mobile health technology
OTHERLifestyle maintenance
Continue current lifestyle
Sponsors
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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);
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly minutes of moderate-vigorous physical activity | Baseline and 8 weeks | Measured using a Geneactiv wrist-based activity monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline and 8 weeks | Measured in centimetres |
| Waist to hip ratio | Baseline and 8 weeks | Measured in centimetres |
| 1-minute sit to stand test | Baseline and 8 weeks | Participant stands up and sits down from a chair for one minute and the number of completed sit-to-stands is recorded. |
| Multidimensional Fatigue Inventory | Baseline and 8 weeks | Measured on 20 questions with a scale of 1-5. The maximum possible score is 100 with a higher score indicating more acute levels of fatigue |
| Cystic Fibrosis Questionnaire Revised | Baseline and 8 weeks | Quality of life questionnaire validated for Cystic Fibrosis. Scores range from 0 to 100, with higher scores indicating better health. |
| Manchester Musculoskeletal Screening tool | Baseline and 8 weeks | Musculoskeletal pain questionnaire. A higher score indicates a worse outcome. Maximum possible score is 50, minimum possible score is 0 |
| Sleep quality | Baseline and 8 weeks | 3-day sleep quality and quantity diary |
| Body mass index | Baseline and 8 weeks | kg/m2 |
| Fasting triglyceride concentration, mmol/L | Baseline and 8 weeks | Taken with the early morning fasted capillary blood sample |
| Serum fructosamine, mmol/L | Baseline and 8 weeks | Taken from the fasted early morning capillary blood sample |
| Fasting LDL-C, HDL-C and total cholesterol, mmol/L | Baseline and 8 weeks | Taken from the fasted early morning capillary blood samples |
| High sensitivity C-reactive protein, mg/L | Baseline and 8 weeks | Measured in the capillary blood samples taken |
| Forced expiratory volume in one second | Baseline and 8 weeks | Obtained by spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values |
| Forced Vital Capacity | Baseline and 8 weeks | Obtained through spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values. |
| Fasting insulin levels, pmol/L | Baseline and 8 weeks | Taken from the early morning fasted capillary blood sample |
Countries
United Kingdom
Contacts
Primary ContactRachel C McDowell
Outcome results
None listed