Pilot Trial of ExACT (Exercise as Airway Clearance Therapy) for People With Cystic Fibrosis

NCT05482048 | Unknown DMC

• 1 other identifier: NIHR203185
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of participants recruited into study (quantitative)

  Number recruited and randomised 1:1 into the study

  6 months

Secondary Outcomes (16)

• Number of participants completing study (quantitative)

  28 days

• Number of people completing study

  6 months

• Number of people who choose intervention

  6 months

• Qualitative interview data

  6 months

• Change in LCI2.5

  28 days

Study Arms (2)

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.

Other: Exercise as Airway Clearance Therapy (ExACT)

Interventions

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.

Exercise as Airway Clearance Therapy (ExACT)

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Royal Hospital for Children and Young People, Edinburgh: collaborator
• University of Edinburgh: collaborator
• Cystic Fibrosis Trust: collaborator
• Department of Sport, Exercise and Rehabilitation, University of Northumbria at Newcastle: collaborator
• Department of Psychology, University of Portsmouth: collaborator
• Queen Elizabeth University Hospital Glasgow: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Dr Zoe Saynor

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

Related Publications (2)

• Urquhart 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. 2025 Oct 1:thorax-2025-223080. doi: 10.1136/thorax-2025-223080. Online ahead of print.

  PMID: 41033804 DERIVED

• Urquhart 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.

  PMID: 37881306 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Clinical Exercise Physiology

Model Details: Two-arm randomised, pilot trial with an embedded qualitative component

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 1, 2022
• Study Start: February 2, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)