Remote Exercise to Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis (RHH-CF)

Not Applicable

Not yet recruiting

• Conditions: Cystic Fibrosis (CF); Cardiovascular Disease Risk Factors

• Registration Number: NCT07027553
• Lead Sponsor: University of Bath

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-10
• Study First Posted: 2025-06-18
• Study Start: 2025-06-19
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-05-19
• Study Completion: 2026-09-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weekly minutes of moderate-vigorous physical activity	Baseline and 8 weeks	Measured using a Geneactiv wrist-based activity monitor

Secondary Outcome Measures

Name	Time	Method
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.
Serum fructosamine, mmol/L	Baseline and 8 weeks	Taken from the fasted early morning capillary blood sample
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
Fasting insulin levels, pmol/L	Baseline and 8 weeks	Taken from the early morning fasted capillary blood sample
Fasting triglyceride concentration, mmol/L	Baseline and 8 weeks	Taken with the early morning fasted capillary blood sample
Body mass index	Baseline and 8 weeks	kg/m2
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
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.

Trial Locations

Locations (1)

Centre for Nutrition, Exercise and Metabolism; 🇬🇧 Bath, United Kingdom