Clinical trial NCT07027553: Remote Exercise to Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis (RHH-CF)
Official title: A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis (CF)
Cardiovascular Disease Risk Factors
Keywords: Exercise
Physical activity
Cystic Fibrosis
Cardiovascular disease risk
Mobile health interventions
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weekly minutes of moderate-vigorous physical activity
timeFrame: For 7 days before and during the final week of the activity intervention
Secondary outcomes:
measure: Body mass index
timeFrame: Prior to and after the end of the 8 week intervention
measure: Waist circumference
timeFrame: Prior to and after the end of the 8 week intervention
measure: Waist to hip ratio
timeFrame: Prior to and after the 8 week intervention
measure: 1-minute sit to stand test
timeFrame: Prior to and after the end of the 8 week intervention
measure: Multidimensional Fatigue Inventory
timeFrame: Prior to and after the end of the 8 week intervention
measure: Cystic Fibrosis Questionnaire Revised
timeFrame: Prior to and after the end of the 8 week intervention
measure: Manchester Musculoskeletal Screening tool
timeFrame: Prior to and after the end of the 8 week intervention
measure: Sleep quality
timeFrame: Prior to and after the end of the 8 week intervention
measure: Fasting insulin levels, pmol/L
timeFrame: Prior to and during the final week of the 8 week intervention
measure: Fasting triglyceride concentration, mmol/L
timeFrame: Prior to and after the end of the 8 week intervention
measure: Serum fructosamine, mmol/L
timeFrame: Prior to and after the end of the 8 week intervention
measure: Fasting LDL-C, HDL-C and total cholesterol, mmol/L
timeFrame: Prior to and after the end of the 8 week intervention
measure: High sensitivity C-reactive protein, mg/L
timeFrame: Prior to and during the final week of the 8 week intervention
measure: Forced expiratory volume in one second
timeFrame: Prior to and after the end of the 8 week intervention
measure: Forced Vital Capacity
timeFrame: Prior to and during the final week of the 8 week intervention
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Centre for Nutrition, Exercise and Metabolism
Study officials:
References: