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NCT Number: NCT07027553

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Nutrition, Exercise and Metabolism

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile health exercise programme

Behavioral

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

Lifestyle maintenance

Other

Continue current lifestyle

Primary outcomes

  1. Weekly minutes of moderate-vigorous physical activity

    Time frame: Baseline and 8 weeks

    Measured using a Geneactiv wrist-based activity monitor

Secondary outcomes

  1. Body mass index

    Time frame: Baseline and 8 weeks

    kg/m2

  2. Waist circumference

    Time frame: Baseline and 8 weeks

    Measured in centimetres

  3. Waist to hip ratio

    Time frame: Baseline and 8 weeks

    Measured in centimetres

  4. 1-minute sit to stand test

    Time frame: 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.

  5. Multidimensional Fatigue Inventory

    Time frame: 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

  6. Cystic Fibrosis Questionnaire Revised

    Time frame: Baseline and 8 weeks

    Quality of life questionnaire validated for Cystic Fibrosis. Scores range from 0 to 100, with higher scores indicating better health.

  7. Manchester Musculoskeletal Screening tool

    Time frame: Baseline and 8 weeks

    Musculoskeletal pain questionnaire. A higher score indicates a worse outcome. Maximum possible score is 50, minimum possible score is 0

  8. Sleep quality

    Time frame: Baseline and 8 weeks

    3-day sleep quality and quantity diary

  9. Fasting insulin levels, pmol/L

    Time frame: Baseline and 8 weeks

    Taken from the early morning fasted capillary blood sample

  10. Fasting triglyceride concentration, mmol/L

    Time frame: Baseline and 8 weeks

    Taken with the early morning fasted capillary blood sample

  11. Serum fructosamine, mmol/L

    Time frame: Baseline and 8 weeks

    Taken from the fasted early morning capillary blood sample

  12. Fasting LDL-C, HDL-C and total cholesterol, mmol/L

    Time frame: Baseline and 8 weeks

    Taken from the fasted early morning capillary blood samples

  13. High sensitivity C-reactive protein, mg/L

    Time frame: Baseline and 8 weeks

    Measured in the capillary blood samples taken

  14. Forced expiratory volume in one second

    Time frame: Baseline and 8 weeks

    Obtained by spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values

  15. Forced Vital Capacity

    Time frame: Baseline and 8 weeks

    Obtained through spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel C McDowell

CONTACT

[email protected]

01225 388 388

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis

Acronym: RHH-CF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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