Cystic FibrosisExACT-CFNCT05482048
Pilot Trial of ExACT (Exercise as Airway Clearance Therapy) for People With Cystic Fibrosis
A study testing Exercise as Airway Clearance Therapy (ExACT) in people with Cystic Fibrosis, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cystic fibrosis (CF) is the UK s most common inherited genetic condition and affects more than 10,500 people. The disease causes problems with the movement of salt and water in the body, resulting in sticky mucus building up, mostly in the lungs and gut. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise as Airway Clearance Therapy (ExACT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2023to 1 May 2024
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CF diagnosis based on sweat chloride >60mmol/L and CFTR genotype which includes at least one phe508del allele
- Clinically stable
- Baseline lung function (as measured by FEV1) of >40% predicted
- ≥ 10 years of age
- Established (>3 months) on Elexacaftor in combination with Tezacaftor and Ivacaftor (ETI) - Kaftrio®.
- Under the care of the paediatric centres in Southampton and Edinburgh and/or adult centres in Southampton, Edinburgh*
- Paediatric and Adult sites in Glasgow may be utilised in event of under-recruitment to the study
- Able to cooperate with the study protocol
Who cannot join
- Considered clinically unstable by recruiting physician e.g. frequent exacerbations (>3/year in preceding 2 years), variable lung function (FEV1<40% predicted and/or excursions of >20% from baseline). Patients will not be excluded due to any pathogen as long as they are deemed clinically stable.
- Health contraindications to exercise e.g. arthritis, cardiac disease
- Not willing to give consent or to take part in the study (N.B. children will provide assent and require parent/guardian consent)
- Insufficient understanding in regard the trial - e.g. not capable of giving informed consent.
- Previously randomised into this trial
- Participation in a concurrent intervention study in the past 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ExACT-CF: Exercise as an Airway Clearance Technique in People With Cystic Fibrosis - A Randomised Pilot Trial
Cystic fibrosis (CF) is the UK s most common inherited genetic condition and affects more than 10,500 people. The disease causes problems with the movement of salt and water in the body, resulting in sticky mucus building up, mostly in the lungs and gut. Thick mucus in the airways leads to repeated infections which, over time, damage the lungs. Chest physiotherapy is prescribed to loosen and clear sticky thick mucus from the airways and so to help to reduce lung infection. Chest physiotherapy is a routine treatment to keep people with CF healthy. However, many say it is time-consuming and a burden. People with CF have asked if doing exercise could have the same effect as chest physiotherapy sessions for helping clear mucus. Exercise could be more enjoyable and less burdensome. Through a recognised priority setting partnership, the CF community recently ranked research to reduce the burden of their care and answer whether exercise can replace chest physiotherapy , as their number 1 and 7 priorities. Surveys show that many people with CF have occasionally chosen to replace chest physiotherapy with exercise for airway clearance, and we recently confirmed this through a UK-wide survey. It is not known if they would be willing to take part in research that asks some to stop chest physiotherapy and to exercise (with coughs and huffs) instead. New medicine (modulators) have recently become available for many people with CF, bringing dramatic improvements in their health. Some people who have started modulators are considering whether they can reduce or stop treatments - including chest physiotherapy. So, the effects of stopping chest physiotherapy need to be investigated and also if exercise can be used instead - this research study aims to understand this. A recent survey in people with CF, their families, physiotherapists and doctors, conducted by this research team, showed us that many consider hard exercise with coughs and huffs to be able to clear mucus from the airways. This study will recruit 50 people with CF (>12 years old) for 28-days. This study will ask half of them to continue their usual care, and half to stop chest physiotherapy and do exercise that gets them breathing deeply (with coughs and huffs) instead. This study will see if people are willing to start and continue with such a study and what they think of the study processes. It will also see how stopping chest physiotherapy and replacing it with exercise affects measurements of their lung function. The study will also involve talking with people with CF and members of their CF team to understand their experiences. This information will reveal whether a larger study can answer the question of whether certain forms of exercise can safely be used as an alternative to chest physiotherapy.
Read the detailed description
Cystic fibrosis (CF) is the UK's most common inherited genetic condition and affects more than 10,500 people. People with CF have problems with the movement of salt and water in the body, which causes sticky mucus to build up, mostly in the lungs and gut. Thick mucus in the airways leads to repeated infections which may, over time, damage the lungs. All people with CF are therefore asked to use chest physiotherapy 1-2 times a day, to loosen and clear sticky thick mucus from their airways and help reduce their risk of getting a lung infection.
Chest physiotherapy is viewed as a routine treatment to keep people with CF healthy. However, many say it is time-consuming and a burden. People with CF have asked if doing exercise could have the same effect as chest physiotherapy sessions for helping clear mucus. Exercise could be more enjoyable and less burdensome and people with CF are already asked to do it regularly to stay fit and well. Surveys show that many people with CF occasionally choose to replace chest physiotherapy with exercise for airway clearance - we recently confirmed this in a UK-wide survey. It is unknown whether people with CF would be willing to take part in research that asks them to either continue with chest physiotherapy, or to stop this and do exercise (with coughs and huffs) instead.
New medicines (CFTR modulator drugs) have recently become available for many people with CF, bringing dramatic improvements in their health. Many people who have started modulators are considering whether they can reduce or stop other treatments, including chest physiotherapy. So, the effects of stopping chest physiotherapy need to be studied and research is needed to find out if exercise can be used instead - this research study aims to understand this. A recent survey in people with CF, their families, physiotherapists and doctors, undertaken by this research group, revealed that most people with CF consider exercise with coughs and huffs to be able to clear mucus from the airways in a similar manner to chest physiotherapy.
This study will recruit 50 people with CF who are older than 10 years of age for 28-days. It will randomly ask half of them to continue their usual care (chest physiotherapy), and half to stop chest physiotherapy and use exercise airway clearance therapy at least once a day instead - which will be explained to them. Briefly this will involve exercise that is ~20 minutes in duration, at a level where they must breathe deeply, used types of exercise from a list we will provide, and include assessment breaths, coughs and check huffs to help clear any sticky mucus.
This study will see if people are willing to start and continue with such a study and what they think of the study processes. It will also see how stopping chest physiotherapy and replacing it with regular exercise affects the lungs. It will also involve talking with people with CF and members of their CF team to understand their experiences of the research study. This information will reveal whether a larger study can answer the question of whether certain forms of exercise can safely be used as an alternative to chest physiotherapy and also improve what we are doing in any areas if needed.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise as Airway Clearance Therapy (ExACT)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise as Airway Clearance Therapy (ExACT)Other
Arm-2 (ExACT): Participants will be advised to replace routine chest physiotherapy sessions with exercise combined with coughs and huffs - also referred to as forced expiratory techniques (FET). The undertaking of ExACT at least once per day is expected.
Written and verbal instruction will be provided on the type, duration, frequency and intensity of exercise that is considered adequate replacement for routine chest physiotherapy. A compendium of allowable activity types, and the required times at different intensities that are considered to replace chest physiotherapy for ACT The research team will support exercise advice in line with standard care if subjects request this. The trial has no other changes to CF care. All medications, nutritional support and other treatments continue.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | In line with current guidelines [4], participants will continue chest physiotherapy as advised by their physiotherapist (at least one session of ACT/day) and continue to undertake exercise and physical activity at their usual levels. |
| Exercise as Airway Clearance Therapy (ExACT) | Experimental | Arm-2 (ExACT): Participants will be advised to replace routine chest physiotherapy sessions with exercise combined with coughs and huffs - also referred to as forced expiratory techniques (FET) - agreed in our e-Delphi exercise REF and wider PPI discussion as possible alternatives for airway clearance. This intervention we term ExACT*.
The undertaking of ExACT at least once per day is expected of those randomised to Arm 2.
*Although routine chest physiotherapy is being replaced by ExACT, chest physiotherapy is permissible in the event of a chest exacerbation and a protocol deviation will be recorded. Receives: Other: Exercise as Airway Clearance Therapy (ExACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited into study (quantitative)
Number recruited and randomised 1:1 into the study
Measured: 6 months
Secondary outcomes (16)
Number of participants completing study (quantitative)
The proportion of people with CF that attend their baseline visit who also attend the Day 28 visit
Measured: 28 days
Number of people completing study
Proportion of people with CF who complete the study and submit and necessary data
Measured: 6 months
Number of people who choose intervention
The proportion of people with CF that would chose the intervention over usual care (chest physiotherapy) in the future
Measured: 6 months
Qualitative interview data
Thematic analysis of semi-structured interviews of participants and healthcare professional involved with the study
Measured: 6 months
Change in LCI2.5
Between group differences in change in LCI2.5 from baseline to Day 28 after intervention
Measured: 28 days
Change in Forced Expiratory Volume in the 1st second (FEV1) (%predicted)
Between group differences in change in FEV1 (%predicted) from baseline to Day 7, 14, 21 and Day 28
Measured: 28 days
Change in Forced Vital Capacity (FVC) (%predicted)
Between group differences in change in FEV1 (%predicted) from baseline to Day 7, 14, 21 and Day 28
Measured: 28 days
Rates of pulmonary exacerbations
Between group differences in rates of pulmonary exacerbation from baseline to Day 28
Measured: 28 days
Number of adverse events
Between group differences in adverse events and serious adverse event rates from baseline to Day 28
Measured: 28 days
Device-based physical activity (Garmin Vivosmart4 watch)
Between group differences in the amount/type/intensity of physical activity and exercise from baseline to Day 28
Measured: 28 days
Mood
Between group differences in change in mood (HADS) and any change from baseline to Day 28
Measured: 28 days
Quality of life (CFQ-R)
Between group differences in quality of life and any change from baseline to Day 28
Measured: 28 days
Treatment burden
Between group differences in change in treatment burden (CFQ-R Treatment Burden subscale) and any change from baseline to Day 28
Measured: 28 days
Habitual activity estimation scale (HAES)
Between group differences in change in HAES and any change from baseline to Day 28
Measured: 28 days
EQ-5D-5L
Between group differences in change in EQ-5D-5L and any change from baseline to Day 28
Measured: 28 days
Sleep
Between group differences in total sleep time and any change from baseline to Day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start2 Feb 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Two-arm randomised, pilot trial with an embedded qualitative component
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Hospital for Children and Young People, Edinburgh, University of Edinburgh, Cystic Fibrosis Trust, Northumbria University, University of Portsmouth, Queen Elizabeth University Hospital Glasgow, Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Principal investigator, Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482048
- Sponsor's protocol ID
- NIHR203185
- Acronym
- ExACT-CF
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urquhart DS, Taylor EJ, Miller D, Bowens D, Lacey E, Abkir M, Saunders CJ, Cunningham S, Saynor ZL; ExACT-CF study group. Measurement of lung clearance index (LCI2.5) by nitrogen multiple breath washout (N2-MBW) is feasible and well-tolerated by adults and children with cystic fibrosis. BMJ Open Respir Res. 2026 Apr 3;13(1):e003905. doi: 10.1136/bmjresp-2025-003905.
PubMed 41932815Urquhart DS, Taylor E, Cunningham S, Lewis S, Neilson AR, Soilemezi D, Ensor H, Vogiatzis I, Allen LJ, Saynor ZL; ExACT-CF Study Group. Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis: a randomised pilot feasibility trial. Thorax. 2026 Jan 15;81(2):140-149. doi: 10.1136/thorax-2025-223080.
PubMed 41033804Urquhart DS, Cunningham S, Taylor E, Vogiatzis I, Allen L, Lewis S, Neilson AR, Soilemezi D, Akooji N, Saynor ZL. Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial. NIHR Open Res. 2022 Dec 19;2:64. doi: 10.3310/nihropenres.13347.1. eCollection 2022.
PubMed 37881306
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExACT-CF: Exercise as an Airway Clearance Technique in People With Cystic Fibrosis - A Randomised Pilot Trial
- ClinicalTrials.gov ID
- NCT05482048
- Acronym / sponsor ID
- ExACT-CF / NIHR203185
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Hospital for Children and Young People, Edinburgh, University of Edinburgh, Cystic Fibrosis Trust, Northumbria University, University of Portsmouth, Queen Elizabeth University Hospital Glasgow, Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Aug 2022 (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.
Cystic fibrosis (CF) is the UK s most common inherited genetic condition and affects more than 10,500 people. The disease causes problems with the movement of salt and water in the body, resulting in sticky mucus building up, mostly in the lungs and gut. Thick mucus in the airways leads to repeated infections which, over time, damage the lungs. Chest physiotherapy is prescribed to loosen and clear sticky thick mucus from the airways and so to help to reduce lung infection. Chest physiotherapy is a routine treatment to keep people with CF healthy. However, many say it is time-consuming and a burden. People with CF have asked if doing exercise could have the same effect as chest physiotherapy sessions for helping clear mucus. Exercise could be more enjoyable and less burdensome. Through a recognised priority setting partnership, the CF community recently ranked research to reduce the burden of their care and answer whether exercise can replace chest physiotherapy , as their number 1 and 7 priorities. Surveys show that many people with CF have occasionally chosen to replace chest physiotherapy with exercise for airway clearance, and we recently confirmed this through a UK-wide survey. It is not known if they would be willing to take part in research that asks some to stop chest physiotherapy and to exercise (with coughs and huffs) instead. New medicine (modulators) have recently become available for many people with CF, bringing dramatic improvements in their health. Some people who have started modulators are considering whether they can reduce or stop treatments - including chest physiotherapy. So, the effects of stopping chest physiotherapy need to be investigated and also if exercise can be used instead - this research study aims to understand this. A recent survey in people with CF, their families, physiotherapists and doctors, conducted by this research team, showed us that many consider hard exercise with coughs and huffs to be able to clear mucus from the airways. This study will recruit 50 people with CF (>12 years old) for 28-days. This study will ask half of them to continue their usual care, and half to stop chest physiotherapy and do exercise that gets them breathing deeply (with coughs and huffs) instead. This study will see if people are willing to start and continue with such a study and what they think of the study processes. It will also see how stopping chest physiotherapy and replacing it with exercise affects measurements of their lung function. The study will also involve talking with people with CF and members of their CF team to understand their experiences. This information will reveal whether a larger study can answer the question of whether certain forms of exercise can safely be used as an alternative to chest physiotherapy.
Detailed description
Cystic fibrosis (CF) is the UK's most common inherited genetic condition and affects more than 10,500 people. People with CF have problems with the movement of salt and water in the body, which causes sticky mucus to build up, mostly in the lungs and gut. Thick mucus in the airways leads to repeated infections which may, over time, damage the lungs. All people with CF are therefore asked to use chest physiotherapy 1-2 times a day, to loosen and clear sticky thick mucus from their airways and help reduce their risk of getting a lung infection.
Chest physiotherapy is viewed as a routine treatment to keep people with CF healthy. However, many say it is time-consuming and a burden. People with CF have asked if doing exercise could have the same effect as chest physiotherapy sessions for helping clear mucus. Exercise could be more enjoyable and less burdensome and people with CF are already asked to do it regularly to stay fit and well. Surveys show that many people with CF occasionally choose to replace chest physiotherapy with exercise for airway clearance - we recently confirmed this in a UK-wide survey. It is unknown whether people with CF would be willing to take part in research that asks them to either continue with chest physiotherapy, or to stop this and do exercise (with coughs and huffs) instead.
New medicines (CFTR modulator drugs) have recently become available for many people with CF, bringing dramatic improvements in their health. Many people who have started modulators are considering whether they can reduce or stop other treatments, including chest physiotherapy. So, the effects of stopping chest physiotherapy need to be studied and research is needed to find out if exercise can be used instead - this research study aims to understand this. A recent survey in people with CF, their families, physiotherapists and doctors, undertaken by this research group, revealed that most people with CF consider exercise with coughs and huffs to be able to clear mucus from the airways in a similar manner to chest physiotherapy.
This study will recruit 50 people with CF who are older than 10 years of age for 28-days. It will randomly ask half of them to continue their usual care (chest physiotherapy), and half to stop chest physiotherapy and use exercise airway clearance therapy at least once a day instead - which will be explained to them. Briefly this will involve exercise that is ~20 minutes in duration, at a level where they must breathe deeply, used types of exercise from a list we will provide, and include assessment breaths, coughs and check huffs to help clear any sticky mucus.
This study will see if people are willing to start and continue with such a study and what they think of the study processes. It will also see how stopping chest physiotherapy and replacing it with regular exercise affects the lungs. It will also involve talking with people with CF and members of their CF team to understand their experiences of the research study. This information will reveal whether a larger study can answer the question of whether certain forms of exercise can safely be used as an alternative to chest physiotherapy and also improve what we are doing in any areas if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomised, pilot trial with an embedded qualitative component
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –In line with current guidelines [4], participants will continue chest physiotherapy as advised by their physiotherapist (at least one session of ACT/day) and continue to undertake exercise and physical activity at their usual levels. |
| Exercise as Airway Clearance Therapy (ExACT) | Experimental | Other: Exercise as Airway Clearance Therapy (ExACT)Arm-2 (ExACT): Participants will be advised to replace routine chest physiotherapy sessions with exercise combined with coughs and huffs - also referred to as forced expiratory techniques (FET) - agreed in our e-Delphi exercise REF and wider PPI discussion as possible alternatives for airway clearance. This intervention we term ExACT*. The undertaking of ExACT at least once per day is expected of those randomised to Arm 2. *Although routine chest physiotherapy is being replaced by ExACT, chest physiotherapy is permissible in the event of a chest exacerbation and a protocol deviation will be recorded. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- CF diagnosis based on sweat chloride >60mmol/L and CFTR genotype which includes at least one phe508del allele
- Clinically stable
- Baseline lung function (as measured by FEV1) of >40% predicted
- ≥ 10 years of age
- Established (>3 months) on Elexacaftor in combination with Tezacaftor and Ivacaftor (ETI) - Kaftrio®.
Key exclusion criteria (6 listed)
- Considered clinically unstable by recruiting physician e.g. frequent exacerbations (>3/year in preceding 2 years), variable lung function (FEV1<40% predicted and/or excursions of >20% from baseline). Patients will not be excluded due to any pathogen as long as they are deemed clinically stable.
- Health contraindications to exercise e.g. arthritis, cardiac disease
- Not willing to give consent or to take part in the study (N.B. children will provide assent and require parent/guardian consent)
- Insufficient understanding in regard the trial - e.g. not capable of giving informed consent.
- Previously randomised into this trial
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 |
|---|---|---|
| Exercise as Airway Clearance Therapy (ExACT)Arm-2 (ExACT): Participants will be advised to replace routine chest physiotherapy sessions with exercise combined with coughs and huffs - also referred to as forced expiratory techniques (FET). The undertaking of ExACT at least once per day is expected. Written and verbal instruction will be provided on the type, duration, frequency and intensity of exercise that is considered adequate replacement for routine chest physiotherapy. A compendium of allowable activity types, and the required times at different intensities that are considered to replace chest physiotherapy for ACT The research team will support exercise advice in line with standard care if subjects request this. The trial has no other changes to CF care. All medications, nutritional support and other treatments continue. | Other | Exercise as Airway Clearance Therapy (ExACT) |
Primary outcome
Number of participants recruited into study (quantitative)
Time frame: 6 months
Number recruited and randomised 1:1 into the study
16 secondary outcomes
Number of participants completing study (quantitative)
Time frame: 28 days
Number of people completing study
Time frame: 6 months
Number of people who choose intervention
Time frame: 6 months
Qualitative interview data
Time frame: 6 months
Change in LCI2.5
Time frame: 28 days
Change in Forced Expiratory Volume in the 1st second (FEV1) (%predicted)
Time frame: 28 days
Change in Forced Vital Capacity (FVC) (%predicted)
Time frame: 28 days
Rates of pulmonary exacerbations
Time frame: 28 days
Number of adverse events
Time frame: 28 days
Device-based physical activity (Garmin Vivosmart4 watch)
Time frame: 28 days
Mood
Time frame: 28 days
Quality of life (CFQ-R)
Time frame: 28 days
Treatment burden
Time frame: 28 days
Habitual activity estimation scale (HAES)
Time frame: 28 days
EQ-5D-5L
Time frame: 28 days
Sleep
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 41932815Urquhart DS, Taylor EJ, Miller D, Bowens D, Lacey E, Abkir M, Saunders CJ, Cunningham S, Saynor ZL; ExACT-CF study group. Measurement of lung clearance index (LCI2.5) by nitrogen multiple breath washout (N2-MBW) is feasible and well-tolerated by adults and children with cystic fibrosis. BMJ Open Respir Res. 2026 Apr 3;13(1):e003905. doi: 10.1136/bmjresp-2025-003905.
- Derived from this study: PubMed 41033804Urquhart DS, Taylor E, Cunningham S, Lewis S, Neilson AR, Soilemezi D, Ensor H, Vogiatzis I, Allen LJ, Saynor ZL; ExACT-CF Study Group. Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis: a randomised pilot feasibility trial. Thorax. 2026 Jan 15;81(2):140-149. doi: 10.1136/thorax-2025-223080.
- Derived from this study: PubMed 37881306Urquhart DS, Cunningham S, Taylor E, Vogiatzis I, Allen L, Lewis S, Neilson AR, Soilemezi D, Akooji N, Saynor ZL. Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial. NIHR Open Res. 2022 Dec 19;2:64. doi: 10.3310/nihropenres.13347.1. eCollection 2022.
- Individual participant dataSharing planned: No
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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 Exercise as Airway Clearance Therapy (ExACT) in people with Cystic Fibrosis, run by University Hospital Southampton NHS Foundation Trust 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
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?
Number of participants recruited into study (quantitative) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482048, which also lists 3 linked publications.
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 24 Nov 2023.