Centre for Nutrition, Exercise and Metabolism
Bath, BA2 7AY, United Kingdom
NCT Number: NCT07027553
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Bath, BA2 7AY, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 week personalised exercise intervention. Delivered and monitored via mobile health technology
Continue current lifestyle
Time frame: Baseline and 8 weeks
Measured using a Geneactiv wrist-based activity monitor
Time frame: Baseline and 8 weeks
kg/m2
Time frame: Baseline and 8 weeks
Measured in centimetres
Time frame: Baseline and 8 weeks
Measured in centimetres
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.
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
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.
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
Time frame: Baseline and 8 weeks
3-day sleep quality and quantity diary
Time frame: Baseline and 8 weeks
Taken from the early morning fasted capillary blood sample
Time frame: Baseline and 8 weeks
Taken with the early morning fasted capillary blood sample
Time frame: Baseline and 8 weeks
Taken from the fasted early morning capillary blood sample
Time frame: Baseline and 8 weeks
Taken from the fasted early morning capillary blood samples
Time frame: Baseline and 8 weeks
Measured in the capillary blood samples taken
Time frame: Baseline and 8 weeks
Obtained by spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values
Time frame: Baseline and 8 weeks
Obtained through spirometry. Recorded as litres per minute and percentage predicted values using Global Lung Index reference values.
Contact information is provided by the study sponsor or research team.
University of Bath
Other
A Research Study to Understand Whether Remote Exercise Can Improve Physical Activity Levels and Markers of Heart Health in Cystic Fibrosis
Acronym: RHH-CF
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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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