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

NCT07027553 | Not Yet Recruiting

• 1 other identifier: 7241-11903
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis (CF); Cardiovascular Disease Risk Factors

Keywords

Exercise; Physical activity; Cystic Fibrosis; Cardiovascular disease risk; Mobile health interventions

Outcome Measures

Primary Outcomes (1)

• Weekly minutes of moderate-vigorous physical activity

  Measured using a Geneactiv wrist-based activity monitor

  Baseline and 8 weeks

Secondary Outcomes (15)

• Body mass index

  Baseline and 8 weeks

• Waist circumference

  Baseline and 8 weeks

• Waist to hip ratio

  Baseline and 8 weeks

• 1-minute sit to stand test

  Baseline and 8 weeks

• Multidimensional Fatigue Inventory

  Baseline and 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Mobile health exercise programme

Control

ACTIVE COMPARATOR

Other: Lifestyle maintenance

Interventions

Mobile health exercise programme BEHAVIORAL

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

Intervention

Lifestyle maintenance OTHER

Continue current lifestyle

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

Centre for Nutrition, Exercise and Metabolism

Bath, BA2 7AY, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Central Study Contacts

Rachel C McDowell

CONTACT

01225 388 388; rcm76@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GW4-CAT PhD Programme for Health Professionals PhD Programme Fellow

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 18, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): September 19, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: These will become available at the point of publication permanently.

Locations

GB (1)