Health TrialsbyHealthPanel

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

ConditionsCystic Fibrosis (CF)Cardiovascular Disease Risk Factors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Bath

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobile health exercise programme

    Behavioral

    8 week personalised exercise intervention. Delivered and monitored via mobile health technology

  • Lifestyle maintenance

    Other intervention

    Continue current lifestyle

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weekly minutes of moderate-vigorous physical activity

Measured using a Geneactiv wrist-based activity monitor

Time frame
Baseline and 8 weeks

Secondary outcomes

1

Body mass index

kg/m2

Time frame
Baseline and 8 weeks
2

Waist circumference

Measured in centimetres

Time frame
Baseline and 8 weeks
3

Waist to hip ratio

Measured in centimetres

Time frame
Baseline and 8 weeks
4

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.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bath

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: