Cystic FibrosisNCT03237767
A CFit Study - Acute Exercise
A study testing MIE and HIIE in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research aiming to maximise the quality of life (QoL) of the aging CF population. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- What is being tested?
- MIE and HIIE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 12 years of age
- CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride > 60 mmol·L-1 > 100 mg sweat) and, where possible, diagnostic genotyping
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
- No increase in symptoms or weight loss in the preceding 2 weeks
Who cannot join
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
- Unstable co-morbid asthma (daily pulmonary function variability of > 20%)
- Is pregnant during the initial screening process
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not of a suitable age for testing
- Onset of acute infection
Show all 10Show fewer
- Becomes and/or is tested to be pregnant following enrolment to the study
- Experiences significant hypoxaemia during visit 2 of the CFit_BL protocol (IRAS ID: 225310) which requires supplemental O₂. Under these circumstances, participants will be invited to continue their participation under the CFit_BL trial (IRAS ID: 225310)
- Unable to understand or cooperate with study protocol
- The individual does not wish to participate further
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Sport and Exercise Science
Portsmouth, Hampshire, PO1 2ER
About this study
Official title: A CFit Study: To What Extent Does a Single Session of Exercise Training Influence Measures of Inflammation, Oxidative Stress, Nitric Oxide Bioavailability, Microvascular Endothelial Function and Dysglycaemia in Patients With Cystic Fibrosis?
A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research aiming to maximise the quality of life (QoL) of the aging CF population. Over recent decades, exercise training has become an integral part of CF management by improving ones aerobic exercise function and QoL. However, the effects exercise training has upon other aspects of the disease, e.g. metabolic and vascular abnormalities, remains largely unknown.
The increased survival age associated with CF means the non-pulmonary co-morbidities are becoming increasingly prevalent and clinically important. For example, CF-related diabetes (CFRD) is one of the most common non-pulmonary co-morbidities of CF, and is associated with patients having a poorer pulmonary function and nutritional state, which ultimately leads to a worsened prognosis. Despite the efficacy of exercise training to manage dysglycaemia in other populations (e.g. type 2 diabetes mellitus only a single study has investigated its efficacy in patients with CF, whereby authors reported various encouraging findings (e.g. an improved OGTT score and insulin sensitivity).
Read more
The present study aims to build on previous trials by comparing the therapeutic effects of a single session of high-intensity interval exercise (HIIE) and moderate intensity exercise (MIE) upon the 24 hour, ambulatory glycaemic profile of patients with CF. Additionally, the present study will identify whether HIIE and/or MIE can mediate the consequences of transient hyperglycaemia when considering: biomarkers of inflammation, oxidative stress and nitric oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial function.
The present study supports the top 10 research priorities set by the CF Trust, by further investigating the potential for exercise training to prevent/manage multiple aspects of CF, including dysglycaemia.
Read the detailed description
Participants and recruitment The present study will be a pilot, counter-balanced, cross-over trial in individuals with CF (n = 16). Furthermore, the present protocol is an extension of the CFit_BL protocol (Clinical Trials ID to be confirmed). Specifically, 16 participants with CF will be invited to complete 2 visits (5 in total) within the same 14 day time period. Briefly, participants will be recruited from adult and paediatric CF outpatient clinics within the Southampton CF network, and will be tested at a laboratory within the Southampton General Hospital or the Department of Sport and Exercise Sciences (University of Portsmouth), depending on participant convenience.
The present study will comprise 2 visits which will be in a randomised, counter-balanced order.
Visits 1 and 2 A session of moderate intensity exercise (MIE) training and high-intensity interval exercise (HIIE) training visit will be conducted in a randomised, counter-balanced order. Participants will be required to arrive to the laboratory ~ 96 hours following the previous visit, at 0800 ± 2 hours, following an overnight fast (> 10 hours). Furthermore, participants will be instructed to avoid nitrate rich foods, caffeine, alcohol and exhaustive exercise for 24 hours prior to arrival, as well as mouthwash for the entirety of the study.
Upon arrival, CGM's will be fixed to the interior surface of the upper arm and worn for the subsequent 14 days. In addition to this, hip worn accelerometers, as well as hourly specific physical activity and food diaries will be distributed and completed for 14 days alongside the CGM.
Upon arrival participants will undergo the acetylcholine (ACh) and insulin iontophoresis protocols described below, including 5 resting blood pressure measurements and a cannula will be inserted into a vein by a trained phlebotomist, prior to the 3 hour OGTT and a baseline blood sample will be taken. The participant's pulmonary function will be assessed via spirometry. Participants will then be asked to complete either a single session of either MIE or HIIE.
Pulmonary function will then be assessed immediately post-exercise. 1 hour following exercise, the iontophoresis procedures will be repeated. Blood samples will be drawn immediately pre- and post-exercise for the analysis of plasma TNF-α, soluble vascular cell adhesion molecule (sVCAM)-1, IL-6, [NO-(₂)] and ET-1. Samples for nitrotyrosine (NT), total glutathione (tGSH) and total cysteine (tCys) will be drawn pre-exercise only. Subsequently, participants will partake in either 30 minutes of MIE or a work-matched period of HIIE. Thirty minutes following the completion of the exercising procedures, the iontophoresis procedures will be repeated and blood samples will be drawn for the analysis of plasma glucose, insulin, TNF-α, sVCAM-1, IL-6, [NO-(₂)] and ET-1. NT, tGSH and tCys. Following this, 1.75 g/kg body mass (maximum of 75 g) of anhydrous glucose will be consumed to instigate the 3 hour OGTT, whereby blood samples will be drawn at 30, 60, 90, 120 and 180 minutes post-glucose ingestion for the analysis of glucose and insulin. Samples for TNF-α, sVCAM-1, IL-6, [NO-(₂)] and ET-1 will be drawn at 60, 120 and 180 minutes post-glucose ingestion. NT, tGSH and tCys will be analysed at 120 minutes post-glucose ingestion. The total volume of blood collected over each 5 hour visit will be approximately 232 mL. Additionally, the iontophoresis procedures will be repeated at 30, 90 and 150 minutes post-glucose ingestion.
Follow-up CGM's, accelerometers and physical activity/food diaries will be completed throughout this 14 day period. A member of the research team will collect these from the preferred location of the participant.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Being tested
- MIE, HIIE
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIEOther
The moderate intensity exercise (MIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits.
The MIE bout will be in coherence with the physical activity guidelines for people with CF (150 min/week of moderate to vigorous physical activity). For the MIE, participants will cycle for approximately 30 minutes at 90% of their gas exchange threshold.
HIIEOther
The high-intensity interval exercise (HIIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits.
The HIIE will be matched for the projected work done during the MIE. The HIIE protocol has been extrapolated from recent reports which have shown improvements in glycaemic control and vascular endothelial function. Specifically, participants will cycle at 90% of their peak power output for 60 seconds, followed by 60 seconds of active recovery.
| Study group | Role | What they receive |
|---|---|---|
| Moderate vs. High-intensity exercise (randomised) | Experimental | Compare the effects of a single session of moderate continuous exercise versus high-intensity interval exercise (MIE completed first) Receives: Other: MIE; Other: HIIE |
| High-intensity vs. Moderate intensity exercise (randomised) | Experimental | Compare the effects of a single session of moderate continuous exercise versus high-intensity interval exercise (HIIE completed first) Receives: Other: MIE; Other: HIIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration before and after oral glucose tolerance test
Glucose concentration before and after oral glucose tolerance test (which follows an exercise training session)
Measured: Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion)
Insulin concentration before and after oral glucose tolerance tolerance
Insulin concentration before and after oral glucose tolerance test (which follows an exercise training session)
Measured: Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion)
Glycaemic control (measured using arm-mounted Freestyle Libre continuous glucose monitor)
Glycaemic control fixed to the arm will measure glucose excursions continuously
Measured: Continuous measurement through study completion (2 week period)
Secondary outcomes (13)
Nitrotyrosine (NT)
Nitrotyrosine (NT) measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: NT measured immediately before glucose ingestion and 120 minutes after
Total cysteine (tCys)
Total cysteine (tCys) measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tCys measured immediately before glucose ingestion and 120 minutes after
Total glutathione (tGSH)
Total glutathione (tGSH) measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tGSH measured immediately before glucose ingestion and 120 minutes after
Tumor necrosis factor alpha (TNF-alpha)
Tumor necrosis factor alpha (TNF-alpha) measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: TNF-alpha measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Soluble vascular cell adhesion molecule (sVCAM-1)
Soluble vascular cell adhesion molecule-1 (sVCAM-1) measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: sVCAM-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Endothelin-1 (ET-1)
Endothelin-1 (ET-1)
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: ET-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: IL-6 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
[Nitrite] ([NO2])
[Nitrite] ([NO2])measured from plasma
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: NO2 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Pulmonary function (forced expiratory volume in 1 second, forced vital capacity, peaf expiratory flow and mid-forced expiratory flow) measured using flow-volume loop spirometry
Pulmonary function will be measured using flow-volume spirometry and presented in both absolute units and as a percentage of predictive normative reference values
Measured: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: pulmonary function measured immediately before glucose ingestion
Insulin iontophoresis
Insulin iontophoresis measures of microvascular endothelial function
Measured: Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: insulin iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after.
Acetylcholine iontophoresis
Acetylcholine iontophoresis measures of microvascular endothelial function
Measured: Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: acetylcholine iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after.
Dietary intake
Dietary intake measured using MyFitness Pal application and dietary records
Measured: Continuous measurement through study completion (2 weeks), participants will record everything that they eat and drink
Physical activity
Physical activity measured using wrist worn accelerometer (GeneActiv)
Measured: Continuous measurement through study completion (2 week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 May 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The present study will be a pilot, counter-balanced, cross-over trial in individuals with CF.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Alexandra Hospital, Portsmouth, University Hospital Southampton NHS Foundation Trust, Loughborough University
- Responsible party
- Principal investigator, Dr Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237767
- Sponsor's protocol ID
- ZS003
- Status last verified
- Apr 2021
- First submitted
- 26 Jul 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with the research team only.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CFit Study: To What Extent Does a Single Session of Exercise Training Influence Measures of Inflammation, Oxidative Stress, Nitric Oxide Bioavailability, Microvascular Endothelial Function and Dysglycaemia in Patients With Cystic Fibrosis?
- ClinicalTrials.gov ID
- NCT03237767
- Acronym / sponsor ID
- ZS003
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Queen Alexandra Hospital, Portsmouth, University Hospital Southampton NHS Foundation Trust, Loughborough University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 3 Aug 2017 (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.
A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research aiming to maximise the quality of life (QoL) of the aging CF population. Over recent decades, exercise training has become an integral part of CF management by improving ones aerobic exercise function and QoL. However, the effects exercise training has upon other aspects of the disease, e.g. metabolic and vascular abnormalities, remains largely unknown.
The increased survival age associated with CF means the non-pulmonary co-morbidities are becoming increasingly prevalent and clinically important. For example, CF-related diabetes (CFRD) is one of the most common non-pulmonary co-morbidities of CF, and is associated with patients having a poorer pulmonary function and nutritional state, which ultimately leads to a worsened prognosis. Despite the efficacy of exercise training to manage dysglycaemia in other populations (e.g. type 2 diabetes mellitus only a single study has investigated its efficacy in patients with CF, whereby authors reported various encouraging findings (e.g. an improved OGTT score and insulin sensitivity).
The present study aims to build on previous trials by comparing the therapeutic effects of a single session of high-intensity interval exercise (HIIE) and moderate intensity exercise (MIE) upon the 24 hour, ambulatory glycaemic profile of patients with CF. Additionally, the present study will identify whether HIIE and/or MIE can mediate the consequences of transient hyperglycaemia when considering: biomarkers of inflammation, oxidative stress and nitric oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial function.
The present study supports the top 10 research priorities set by the CF Trust, by further investigating the potential for exercise training to prevent/manage multiple aspects of CF, including dysglycaemia.
Detailed description
Participants and recruitment The present study will be a pilot, counter-balanced, cross-over trial in individuals with CF (n = 16). Furthermore, the present protocol is an extension of the CFit_BL protocol (Clinical Trials ID to be confirmed). Specifically, 16 participants with CF will be invited to complete 2 visits (5 in total) within the same 14 day time period. Briefly, participants will be recruited from adult and paediatric CF outpatient clinics within the Southampton CF network, and will be tested at a laboratory within the Southampton General Hospital or the Department of Sport and Exercise Sciences (University of Portsmouth), depending on participant convenience.
The present study will comprise 2 visits which will be in a randomised, counter-balanced order.
Visits 1 and 2 A session of moderate intensity exercise (MIE) training and high-intensity interval exercise (HIIE) training visit will be conducted in a randomised, counter-balanced order. Participants will be required to arrive to the laboratory ~ 96 hours following the previous visit, at 0800 ± 2 hours, following an overnight fast (> 10 hours). Furthermore, participants will be instructed to avoid nitrate rich foods, caffeine, alcohol and exhaustive exercise for 24 hours prior to arrival, as well as mouthwash for the entirety of the study.
Upon arrival, CGM's will be fixed to the interior surface of the upper arm and worn for the subsequent 14 days. In addition to this, hip worn accelerometers, as well as hourly specific physical activity and food diaries will be distributed and completed for 14 days alongside the CGM.
Upon arrival participants will undergo the acetylcholine (ACh) and insulin iontophoresis protocols described below, including 5 resting blood pressure measurements and a cannula will be inserted into a vein by a trained phlebotomist, prior to the 3 hour OGTT and a baseline blood sample will be taken. The participant's pulmonary function will be assessed via spirometry. Participants will then be asked to complete either a single session of either MIE or HIIE.
Pulmonary function will then be assessed immediately post-exercise. 1 hour following exercise, the iontophoresis procedures will be repeated. Blood samples will be drawn immediately pre- and post-exercise for the analysis of plasma TNF-α, soluble vascular cell adhesion molecule (sVCAM)-1, IL-6, [NO-(₂)] and ET-1. Samples for nitrotyrosine (NT), total glutathione (tGSH) and total cysteine (tCys) will be drawn pre-exercise only. Subsequently, participants will partake in either 30 minutes of MIE or a work-matched period of HIIE. Thirty minutes following the completion of the exercising procedures, the iontophoresis procedures will be repeated and blood samples will be drawn for the analysis of plasma glucose, insulin, TNF-α, sVCAM-1, IL-6, [NO-(₂)] and ET-1. NT, tGSH and tCys. Following this, 1.75 g/kg body mass (maximum of 75 g) of anhydrous glucose will be consumed to instigate the 3 hour OGTT, whereby blood samples will be drawn at 30, 60, 90, 120 and 180 minutes post-glucose ingestion for the analysis of glucose and insulin. Samples for TNF-α, sVCAM-1, IL-6, [NO-(₂)] and ET-1 will be drawn at 60, 120 and 180 minutes post-glucose ingestion. NT, tGSH and tCys will be analysed at 120 minutes post-glucose ingestion. The total volume of blood collected over each 5 hour visit will be approximately 232 mL. Additionally, the iontophoresis procedures will be repeated at 30, 90 and 150 minutes post-glucose ingestion.
Follow-up CGM's, accelerometers and physical activity/food diaries will be completed throughout this 14 day period. A member of the research team will collect these from the preferred location of the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study will be a pilot, counter-balanced, cross-over trial in individuals with CF.
| Arm | Type | Receives |
|---|---|---|
| Moderate vs. High-intensity exercise (randomised) | Experimental | Other: MIE, Other: HIIECompare the effects of a single session of moderate continuous exercise versus high-intensity interval exercise (MIE completed first) |
| High-intensity vs. Moderate intensity exercise (randomised) | Experimental | Other: MIE, Other: HIIECompare the effects of a single session of moderate continuous exercise versus high-intensity interval exercise (HIIE completed first) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 12 years of age
- CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride > 60 mmol·L-1 > 100 mg sweat) and, where possible, diagnostic genotyping
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
- No increase in symptoms or weight loss in the preceding 2 weeks
Key exclusion criteria (10 listed)
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
- Unstable co-morbid asthma (daily pulmonary function variability of > 20%)
- Is pregnant during the initial screening process
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not of a suitable age for testing
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 |
|---|---|---|
| MIEThe moderate intensity exercise (MIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits. The MIE bout will be in coherence with the physical activity guidelines for people with CF (150 min/week of moderate to vigorous physical activity). For the MIE, participants will cycle for approximately 30 minutes at 90% of their gas exchange threshold. | Other | High-intensity vs. Moderate intensity exercise (randomised), Moderate vs. High-intensity exercise (randomised) |
| HIIEThe high-intensity interval exercise (HIIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits. The HIIE will be matched for the projected work done during the MIE. The HIIE protocol has been extrapolated from recent reports which have shown improvements in glycaemic control and vascular endothelial function. Specifically, participants will cycle at 90% of their peak power output for 60 seconds, followed by 60 seconds of active recovery. | Other | High-intensity vs. Moderate intensity exercise (randomised), Moderate vs. High-intensity exercise (randomised) |
Primary outcome
Glucose concentration before and after oral glucose tolerance test
Time frame: Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion)
Glucose concentration before and after oral glucose tolerance test (which follows an exercise training session)
Insulin concentration before and after oral glucose tolerance tolerance
Time frame: Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion)
Insulin concentration before and after oral glucose tolerance test (which follows an exercise training session)
Glycaemic control (measured using arm-mounted Freestyle Libre continuous glucose monitor)
Time frame: Continuous measurement through study completion (2 week period)
Glycaemic control fixed to the arm will measure glucose excursions continuously
13 secondary outcomes
Nitrotyrosine (NT)
Time frame: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: NT measured immediately before glucose ingestion and 120 minutes after
Total cysteine (tCys)
Time frame: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tCys measured immediately before glucose ingestion and 120 minutes after
Total glutathione (tGSH)
Time frame: Visit 1 and 2: pre-exercise (baseline) and 1 h following exercise 75 g glucose is ingested: tGSH measured immediately before glucose ingestion and 120 minutes after
Tumor necrosis factor alpha (TNF-alpha)
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: TNF-alpha measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Soluble vascular cell adhesion molecule (sVCAM-1)
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: sVCAM-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Endothelin-1 (ET-1)
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: ET-1 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Interleukin-6 (IL-6)
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: IL-6 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
[Nitrite] ([NO2])
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: NO2 measured immediately before glucose ingestion and 60, 120 and 180 minutes after)
Pulmonary function (forced expiratory volume in 1 second, forced vital capacity, peaf expiratory flow and mid-forced expiratory flow) measured using flow-volume loop spirometry
Time frame: Visit 1 and 2: pre-exercise (baseline) and immediately post-exercise, additionally 1 h following exercise 75 g glucose is ingested: pulmonary function measured immediately before glucose ingestion
Insulin iontophoresis
Time frame: Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: insulin iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after.
Acetylcholine iontophoresis
Time frame: Visit 1 and 2: pre-exercise (baseline), additionally 1 h following exercise 75 g glucose is ingested: acetylcholine iontophoresis measured immediately before glucose ingestion and 1, 2 and 3 hours after.
Dietary intake
Time frame: Continuous measurement through study completion (2 weeks), participants will record everything that they eat and drink
Physical activity
Time frame: Continuous measurement through study completion (2 week period)
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. Data will be shared with the research team only.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIE and HIIE in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by University of Portsmouth 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Apr 2021. 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?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose concentration before and after oral glucose tolerance test (time frame: Visit 1 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion), Visit 2 (pre glucose ingestion after exercise completed and 30, 60, 90, 120 and 180 minutes following glucose ingestion)). The study lists 3 primary outcomes in all. 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 28 Apr 2021.