Do Physiotherapy Joint and Muscle Movement (Musculoskeletal) Techniques Improve Posture, Pain, Sputum Clearance, Lung Function or Quality of Life During Admission for a Respiratory Exacerbation in Adults With Cystic Fibrosis?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).
Study Overview
Brief Summary
Hypothesis: The addition of a series of musculoskeletal techniques to normal optimal care for the treatment of a respiratory exacerbation in inpatient adults with cystic fibrosis, will lead to further improvements in pain, posture, sputum clearance, lung function and quality of life.
Detailed Description
Experimental design
A prospective, single blind, randomised control trial.
Methods
50 subjects will be recruited by the admitting physiotherapists from the inpatient wards at Royal Brompton Hospital. Using stratified computer randomisation, the subjects will be allocated to either the control (no treatment group) or the treatment group. The randomisation will be carried out by an independent member of the Department of Cystic Fibrosis and the outcome measures recorded by an observer blind to the randomisation.
Method:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of cystic fibrosis (genotype or sweat sodium >70 millimoles per litre or sweat chloride of >60 millimoles per litre)
- •16 years of age or over
- •Inpatient admission for respiratory exacerbation as defined by the Cystic Fibrosis Trust (Cystic Fibrosis Trust Antibiotic Group 2002)
- •Inpatients able to stand for the measurement period without cardiovascular or respiratory compromise.
Exclusion Criteria
- •Current severe haemoptysis
- •Low bone density (Z score < -3)(World Health Organisation Study Group 1994)
- •Rib fractures
- •Pregnancy
- •Inability to give consent for treatment/ measurement
- •Planned initiation or continuation of treatment in the home environment
- •Current participation in another study.
Arms & Interventions
Treatment Arm 2
Physiotherapy musculoskeletal interventions in addition to normal optimal medical and physiotherapy care
Intervention: Physiotherapy Musculoskeletal Treatment (Other)
Control Arm1
Normal optimal medical and physiotherapy treatment
Intervention: Control group measurements (Other)
Outcomes
Primary Outcomes
Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).
Time Frame: Day 0 of admission, Days 5,10 & prior to discharge
Secondary Outcomes
- Ease of sputum clearance using a 10-centimetre visual analogue scale(Days 0,5,10 & pre discharge)
- Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC)(Days 0,5,10 & pre discharge)
- Pain assessment using a 10-centimetre visual analogue scale(Days 0,5,10 & pre discharge)
- Sputum weight(Days 0,5,10)
- Quality of life - CF-38 questionnaire (Ethics reference number: 98-167)(Days 0 & pre discharge)
- Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983)(Days 0 & pre discharge)