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

Overview

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

• Behavioral Mobile health exercise programme
  8 week personalised exercise intervention. Delivered and monitored via mobile health technology
• Other Lifestyle maintenance
  Continue current lifestyle

Primary outcome measures

• Weekly minutes of moderate-vigorous physical activity [Time frame: Baseline and 8 weeks]

Secondary outcome measures (12)

• Body mass index [Time frame: Baseline and 8 weeks]
• Waist circumference [Time frame: Baseline and 8 weeks]
• Waist to hip ratio [Time frame: Baseline and 8 weeks]
• 1-minute sit to stand test [Time frame: Baseline and 8 weeks]
• Multidimensional Fatigue Inventory [Time frame: Baseline and 8 weeks]
• Cystic Fibrosis Questionnaire Revised [Time frame: Baseline and 8 weeks]
• Manchester Musculoskeletal Screening tool [Time frame: Baseline and 8 weeks]
• Sleep quality [Time frame: Baseline and 8 weeks]
• Fasting insulin levels, pmol/L [Time frame: Baseline and 8 weeks]
• Fasting triglyceride concentration, mmol/L [Time frame: Baseline and 8 weeks]
• Serum fructosamine, mmol/L [Time frame: Baseline and 8 weeks]
• Fasting LDL-C, HDL-C and total cholesterol, mmol/L [Time frame: Baseline and 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United Kingdom · 1 center

• Centre for Nutrition, Exercise and Metabolism — Bath

Identifiers

NCT: NCT07027553 · 7241-11903

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗