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

NCT00806884 | Completed DMC

• 2 other identifiers: 08/H0708/252008CF003B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Musculoskeletal Physiotherapy; Manual therapy; Posture; Pain

Outcome Measures

Primary Outcomes (1)

• Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).

  Day 0 of admission, Days 5,10 & prior to discharge

Secondary Outcomes (6)

• 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

• Ease of sputum clearance using a 10-centimetre visual analogue scale

  Days 0,5,10 & pre discharge

• Quality of life - CF-38 questionnaire (Ethics reference number: 98-167)

  Days 0 & pre discharge

Study Arms (2)

Control Arm1

OTHER

Normal optimal medical and physiotherapy treatment

Other: Control group measurements

Treatment Arm 2

EXPERIMENTAL

Physiotherapy musculoskeletal interventions in addition to normal optimal medical and physiotherapy care

Other: Physiotherapy Musculoskeletal Treatment

Interventions

Physiotherapy Musculoskeletal Treatment OTHER

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.

Also known as: manual therapy, Manual techniques, physiotherapy joint mobilisations, physical therapy joint mobilisations

Treatment Arm 2

Control group measurements OTHER

None other than control group measurements

Control Arm1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis (genotype or sweat sodium \>70 millimoles per litre or sweat chloride of \>60 millimoles per litre)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Professor ME Hodson

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 8, 2015

Record last verified: 2008-12

Locations

GB (1)