Do Physiotherapy Techniques Improve Posture During Admission for a Chest Infection in Adults With Cystic Fibrosis?
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy Musculoskeletal Treatment
Control group measurements
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Musculoskeletal Physiotherapy, Manual therapy, Posture, Pain
Eligibility 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.
Sites / Locations
- Royal Brompton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control Arm1
Treatment Arm 2
Arm Description
Normal optimal medical and physiotherapy treatment
Physiotherapy musculoskeletal interventions in addition to normal optimal medical and physiotherapy care
Outcomes
Primary Outcome Measures
Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).
Secondary Outcome Measures
Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Pain assessment using a 10-centimetre visual analogue scale
Sputum weight
Ease of sputum clearance using a 10-centimetre visual analogue scale
Quality of life - CF-38 questionnaire (Ethics reference number: 98-167)
Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983)
Full Information
NCT ID
NCT00806884
First Posted
December 10, 2008
Last Updated
June 4, 2015
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00806884
Brief Title
Do Physiotherapy Techniques Improve Posture During Admission for a Chest Infection in Adults With Cystic Fibrosis?
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Two key investigators will be involved in the study to perform the treatment intervention as outlined in the paragraphs below
The subjects' records will be reviewed by the key investigators to ensure they meet the inclusion criteria
Prospective subjects will be given written and verbal information about the project and be given 24 hours to consider entry to the study
Subjects will give written consent to participate in the project. The top copy will be included in the patient's medical record and a copy placed in the patient's study file
A letter will be written to the subject's General Practitioner outlining the purpose of the study and inviting him/her to make contact to discuss the study in more detail if there are any queries or concerns
The subjects will be withdrawn if there is a clinical deterioration negating the inclusion criteria or they are discharged for further home intravenous antibiotic treatment
Three independent observers (the senior & junior physiotherapists usually working with this patient group) will be trained to ensure good intra & inter-relater reliability in the recording of the measurements
Intervention for the treatment group:
The treatment group will receive the interventions on top of their usual chest physiotherapy and medical care. A treatment series of gentle joint and muscle movements (musculoskeletal interventions) will be undertaken by a physiotherapist, on alternate days for the duration of admission. The physiotherapy musculoskeletal assessment and intervention may last up to 45 minutes on alternate weekdays and may include one or a combination of the following techniques which are documented in populations with postural changes, thoracic stiffness, discomfort and/or pain:
Specific, gentle oscillatory mobilisations to the rib cage and thoracic spine of the subjects to improve joint alignment and mobility, and to reduce pain. These techniques should optimise chest wall mechanics, improve the length-tension relationships of the muscles and normalise movement to dysfunctional areas (Maitland, Banks et al. 2001;Mulligan 2005)
Treatment of specific muscle dysfunction or tight muscle groups to further optimise muscle length and biomechanical relationships in the area (Massery 2005), leading to improved efficiency of recruitment and improved power output (Travell & Simons 1983)
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 consisting of no more than three specific stretching or strengthening exercises may be given.
Control Group:
The control group will receive their usual medical and physiotherapy management but no placebo intervention.
Data Collection:
The outcome measures will be undertaken by one of three independent observers to pre-agreed protocols, before the first intervention session, and before intervention sessions on day five, day ten and day of discharge. The questionnaires CF-38 and the Hospital Anxiety and Depression Scale will be completed on initiation and completion of the study.
Sample size calculation: The number of patients needed for this study was based on testing of posture before and after musculoskeletal intervention in the outpatient adult cystic fibrosis randomised controlled trial ("Do physiotherapy musculoskeletal techniques improve forced expiratory volume in one second (FEV1) in adults with cystic fibrosis?"; Ethics reference number: 06/Q0404/81). To test for a three point change in thoracic index at the 5% significance level, using a square-root of within-mean standard of error of three would require at least 50 patients to achieve 90% power.
Analysis
Statistical advice was given by Mr Michael Roughton, Statistician, Royal Brompton Hospital and Imperial College London. The data will be analysed using an appropriate test e.g. t-tests or Mann-Whitney tests.
The intra & inter-rater reliability and repeatability of the measurements, by the independent observers, will be determined using Bland Atman plots to ensure they lie within clinically acceptable limits of agreement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Musculoskeletal Physiotherapy, Manual therapy, Posture, Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm1
Arm Type
Other
Arm Description
Normal optimal medical and physiotherapy treatment
Arm Title
Treatment Arm 2
Arm Type
Experimental
Arm Description
Physiotherapy musculoskeletal interventions in addition to normal optimal medical and physiotherapy care
Intervention Type
Other
Intervention Name(s)
Physiotherapy Musculoskeletal Treatment
Other Intervention Name(s)
manual therapy, Manual techniques, physiotherapy joint mobilisations, physical therapy joint mobilisations
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group measurements
Intervention Description
None other than control group measurements
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Time Frame
Days 0,5,10 & pre discharge
Title
Pain assessment using a 10-centimetre visual analogue scale
Time Frame
Days 0,5,10 & pre discharge
Title
Sputum weight
Time Frame
Days 0,5,10
Title
Ease of sputum clearance using a 10-centimetre visual analogue scale
Time Frame
Days 0,5,10 & pre discharge
Title
Quality of life - CF-38 questionnaire (Ethics reference number: 98-167)
Time Frame
Days 0 & pre discharge
Title
Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983)
Time Frame
Days 0 & pre discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor ME Hodson
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
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Do Physiotherapy Techniques Improve Posture During Admission for a Chest Infection in Adults With Cystic Fibrosis?
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