Pilot Trial of ExACT (Exercise as Airway Clearance Therapy) for People With Cystic Fibrosis (ExACT-CF)
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dr Zoe Saynor
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Usual Care
Exercise as Airway Clearance Therapy (ExACT)
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.
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.