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

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00806884
First received: December 10, 2008
Last updated: July 26, 2010
Last verified: December 2008
History of Changes
  Purpose

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 Intervention
Cystic Fibrosis
 Other: Physiotherapy Musculoskeletal Treatment
Other: Control group measurements

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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?

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008). [ Time Frame: Day 0 of admission, Days 5,10 & prior to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC) [ Time Frame: Days 0,5,10 & pre discharge ] [ Designated as safety issue: No ]
  • Pain assessment using a 10-centimetre visual analogue scale [ Time Frame: Days 0,5,10 & pre discharge ] [ Designated as safety issue: No ]
  • Sputum weight [ Time Frame: Days 0,5,10 ] [ Designated as safety issue: No ]
  • Ease of sputum clearance using a 10-centimetre visual analogue scale [ Time Frame: Days 0,5,10 & pre discharge ] [ Designated as safety issue: No ]
  • Quality of life - CF-38 questionnaire (Ethics reference number: 98-167) [ Time Frame: Days 0 & pre discharge ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983) [ Time Frame: Days 0 & pre discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806884

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

No publications provided

Responsible Party: Professor ME Hodson, Royal Brompton & Harefield NHS Trust
ClinicalTrials.gov Identifier: NCT00806884     History of Changes
Other Study ID Numbers: 08/H0708/25, 2008CF003B
Study First Received: December 10, 2008
Last Updated: July 26, 2010
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on June 18, 2013