Cystic Fibrosis (CF)RHH-CFNCT07027553
Remote Exercise to Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis (RHH-CF)
A study testing Mobile health exercise programme and Lifestyle maintenance in people with Cystic Fibrosis (CF) and Cardiovascular Disease Risk Factors, run by University of Bath at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cystic Fibrosis (CF), Cardiovascular Disease Risk Factors
- What is being tested?
- Mobile health exercise programme and Lifestyle maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2025to 19 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Centre for Nutrition, Exercise and Metabolism
Bath, BA2 7AY
About this study
Official title: A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis
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.
- Being tested
- Mobile health exercise programme, Lifestyle maintenance
- Keywords
- Exercise, Physical activity, Cystic Fibrosis, Cardiovascular disease risk, Mobile health interventions
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health exercise programmeBehavioural
8 week personalised exercise intervention. Delivered and monitored via mobile health technology
Lifestyle maintenanceOther
Continue current lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Mobile health exercise programme |
| Control | Active comparator | Not described Receives: Other: Lifestyle maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly minutes of moderate-vigorous physical activity
Measured using a Geneactiv wrist-based activity monitor
Measured: Baseline and 8 weeks
Secondary outcomes (15)
Body mass index
kg/m2
Measured: Baseline and 8 weeks
Waist circumference
Measured in centimetres
Measured: Baseline and 8 weeks
Waist to hip ratio
Measured in centimetres
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Multidimensional Fatigue Inventory
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
Measured: Baseline and 8 weeks
Cystic Fibrosis Questionnaire Revised
Quality of life questionnaire validated for Cystic Fibrosis. Scores range from 0 to 100, with higher scores indicating better health.
Measured: Baseline and 8 weeks
Manchester Musculoskeletal Screening tool
Musculoskeletal pain questionnaire. A higher score indicates a worse outcome. Maximum possible score is 50, minimum possible score is 0
Measured: Baseline and 8 weeks
Sleep quality
3-day sleep quality and quantity diary
Measured: Baseline and 8 weeks
Fasting insulin levels, pmol/L
Taken from the early morning fasted capillary blood sample
Measured: Baseline and 8 weeks
Fasting triglyceride concentration, mmol/L
Taken with the early morning fasted capillary blood sample
Measured: Baseline and 8 weeks
Serum fructosamine, mmol/L
Taken from the fasted early morning capillary blood sample
Measured: Baseline and 8 weeks
Fasting LDL-C, HDL-C and total cholesterol, mmol/L
Taken from the fasted early morning capillary blood samples
Measured: Baseline and 8 weeks
High sensitivity C-reactive protein, mg/L
Measured in the capillary blood samples taken
Measured: Baseline and 8 weeks
Forced expiratory volume in one second
Obtained by spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values
Measured: Baseline and 8 weeks
Forced Vital Capacity
Obtained through spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start19 Jun 2025 (estimated)
- Primary completion19 May 2026 (estimated)
- Study completion19 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel McDowell, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027553
- Sponsor's protocol ID
- 7241-11903
- Acronym
- RHH-CF
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT07027553
- Acronym / sponsor ID
- RHH-CF / 7241-11903
- Keywords
- Exercise, Physical activity, Cystic Fibrosis, Cardiovascular disease risk, Mobile health interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 19 Jun 2025 (estimated)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 19 Sep 2026 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mobile health exercise programme |
| Control | Active comparator | Other: Lifestyle maintenance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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);
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health exercise programme8 week personalised exercise intervention. Delivered and monitored via mobile health technology | Behavioural | Intervention |
| Lifestyle maintenanceContinue current lifestyle | Other | Control |
Primary outcome
Weekly minutes of moderate-vigorous physical activity
Time frame: Baseline and 8 weeks
Measured using a Geneactiv wrist-based activity monitor
15 secondary outcomes
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
High sensitivity C-reactive protein, mg/L
Time frame: Baseline and 8 weeks
Forced expiratory volume in one second
Time frame: Baseline and 8 weeks
Forced Vital Capacity
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health exercise programme and Lifestyle maintenance in people with Cystic Fibrosis (CF) and Cardiovascular Disease Risk Factors, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel C McDowell (01225 388 388, rcm76@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly minutes of moderate-vigorous physical activity (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.