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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile health exercise programme | Behavioral | 8 week personalised exercise intervention. Delivered and monitored via mobile health technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly minutes of moderate-vigorous physical activity | Measured using a Geneactiv wrist-based activity monitor | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | kg/m2 | Baseline and 8 weeks |
| Waist circumference | Measured in centimetres | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel C McDowell | Contact | 01225 388 388 | rcm76@bath.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Nutrition, Exercise and Metabolism | Bath | BA2 7AY | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
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De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
These will become available at the point of publication permanently.
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| Lifestyle maintenance | Other | Continue current lifestyle |
|
| Waist to hip ratio | Measured in centimetres | Baseline and 8 weeks |
| 1-minute sit to stand test | Participant stands up and sits down from a chair for one minute and the number of completed sit-to-stands is recorded. | Baseline and 8 weeks |
| Multidimensional Fatigue Inventory | 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 | Baseline and 8 weeks |
| Cystic Fibrosis Questionnaire Revised | Quality of life questionnaire validated for Cystic Fibrosis. Scores range from 0 to 100, with higher scores indicating better health. | Baseline and 8 weeks |
| Manchester Musculoskeletal Screening tool | Musculoskeletal pain questionnaire. A higher score indicates a worse outcome. Maximum possible score is 50, minimum possible score is 0 | Baseline and 8 weeks |
| Sleep quality | 3-day sleep quality and quantity diary | Baseline and 8 weeks |
| Fasting insulin levels, pmol/L | Taken from the early morning fasted capillary blood sample | Baseline and 8 weeks |
| Fasting triglyceride concentration, mmol/L | Taken with the early morning fasted capillary blood sample | Baseline and 8 weeks |
| Serum fructosamine, mmol/L | Taken from the fasted early morning capillary blood sample | Baseline and 8 weeks |
| Fasting LDL-C, HDL-C and total cholesterol, mmol/L | Taken from the fasted early morning capillary blood samples | Baseline and 8 weeks |
| High sensitivity C-reactive protein, mg/L | Measured in the capillary blood samples taken | Baseline and 8 weeks |
| Forced expiratory volume in one second | Obtained by spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values | Baseline and 8 weeks |
| Forced Vital Capacity | Obtained through spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values. | Baseline and 8 weeks |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |
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