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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2026-09-19

Brief Summary

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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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Detailed Description

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Conditions

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Cystic Fibrosis (CF) Cardiovascular Disease Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Mobile health exercise programme

Intervention Type BEHAVIORAL

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

Control

Group Type ACTIVE_COMPARATOR

Lifestyle maintenance

Intervention Type OTHER

Continue current lifestyle

Interventions

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Mobile health exercise programme

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

Intervention Type BEHAVIORAL

Lifestyle maintenance

Continue current lifestyle

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No