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Investigating The Effect Of IMT In Children And Adults With CF

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Open

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Not Applicable

Full title

Investigating the influence of an Inspiratory Muscle Training program on lung function and quality of life in children and adults with Cystic Fibrosis

The Cystic Fibrosis working group recent recommendations commended the use of physical exercise as part of a multidisciplinary therapeutic strategy, as it has been proven to lower mortality risks in patients. One nonpharmacological intervention which has shown some promising results in recent years is inspiratory muscle training (IMT), which may improve patients’ respiratory muscle and exercise function. Inspiratory muscle training, which involves breathing through a device that provides resistance when you breathe, aims to improve the strength of the lung muscles by making them work harder and therefore making them stronger. Starting IMT in children at the early years of their disease is essential in gaining early health benefits. With adults, Lands et al (1992) found that in later stages of Cystic Fibrosis it is difficult to maintain inspiratory muscle strength, therefore adults adopting IMT training at this stage could increase their muscle strength. In the past 30 years’ life expectancy in Cystic Fibrosis has increased significantly, however as age progresses lung function declines. Therefore, it is essential to determine IMT’s effectiveness in progression from childhood to adulthood. For this new generation of ageing patients, improving lung function and enhancing quality of life is a new challenge for a CF clinical care team, therefore, this potential non-pharmacological intervention warrants further investigation.

Trial type

Non-medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

8 - 16 weeks

Intervention
The name of the treatment or therapy being researched

Exercise intervention - Inspiratory Muscle Training device – PrO2 Fit

Recruitment target
The number of participants who need to be recruited for the trial in the UK

240

Last edited date

25 August 2017

Sponsor

Swansea University

Sponsor type

Academic

Who can take part?

Top inclusion criteria
  • Male and females > 8 years old diagnosed with cystic fibrosis
  • CF diagnosed based on clinical features, supported by an abnormal sweat test (sweat chloride >60 mmol.L-1 > 100mg sweat)
  • Lung function considered stable and within 10% of their best in the preceding 6 months
Top exclusion criteria
  • Patients with severe lung deterioration
  • Patients with Bukholderia cepacian infection and nontuberculous mycobacteria
  • Patients with cor pulmonale, liver cirrhosis and or diabetes mellitus or any non-pulmonary condition that may impair exercise ability and cardiovascular disease

CF centres running this trial

Recruiting

Cardiff and Vale University Health Board

Address

Whitchurch Hospital, Park Road, Whitchurch, Cardiff CF14 7XB

Recruitment starts

August 2017

Recruitment ends

January 2018

Contact

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