Do Physiotherapy Techniques Improve Posture During Admission for a Chest Infection in Adults With Cystic Fibrosis?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806884
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : June 8, 2015
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Physiotherapy Musculoskeletal Treatment Other: Control group measurements Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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?
Study Start Date : June 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Control Arm1
Normal optimal medical and physiotherapy treatment
Other: Control group measurements
None other than control group measurements

Experimental: Treatment Arm 2
Physiotherapy musculoskeletal interventions in addition to normal optimal medical and physiotherapy care
Other: Physiotherapy Musculoskeletal Treatment
Other: Physiotherapy Musculoskeletal Treatment Specific, gentle oscillatory mobilisations to the rib cage and thoracic spine of the subjects to improve joint alignment and mobility, and to reduce pain. Treatment of specific muscle dysfunction or tight muscle groups to further optimise muscle length and biomechanical relationships in the area , leading to improved efficiency of recruitment and improved power output. Postural education and awareness discussions to improve the subject's own joint alignment and ability in a functional manner. A short programme to reinforce the progress during the treatment sessions may be given.
Other Names:
  • manual therapy
  • Manual techniques
  • physiotherapy joint mobilisations
  • physical therapy joint mobilisations

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC) [ Time Frame: Days 0,5,10 & pre discharge ]
  2. Pain assessment using a 10-centimetre visual analogue scale [ Time Frame: Days 0,5,10 & pre discharge ]
  3. Sputum weight [ Time Frame: Days 0,5,10 ]
  4. Ease of sputum clearance using a 10-centimetre visual analogue scale [ Time Frame: Days 0,5,10 & pre discharge ]
  5. Quality of life - CF-38 questionnaire (Ethics reference number: 98-167) [ Time Frame: Days 0 & pre discharge ]
  6. Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983) [ Time Frame: Days 0 & pre discharge ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806884

United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Professor ME Hodson Imperial College London

Responsible Party: Professor ME Hodson, Royal Brompton & Harefield NHS Trust Identifier: NCT00806884     History of Changes
Other Study ID Numbers: 08/H0708/25
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: December 2008

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cystic Fibrosis
Musculoskeletal Physiotherapy
Manual therapy

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases