Contact information
Type
Scientific
Primary contact
Mrs Catherine Alexandra Sandsund
ORCID ID
Contact details
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 020 7352 8121 (X4925)
c.sandsund@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0201189486
Study information
Scientific title
Acronym
Study hypothesis
Do gentle mobilisations to the bones of the rib cage and treatment of the muscles in the surrounding areas improve lung function (forced expiratory volume in one second) in adults with cystic fibrosis?
Ethics approval
Approved by by Brompton, Harefield & NHLI Ethics Committee on 27/11/2006.REC reference number: 06/Q0404/81.
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Cystic fibrosis
Intervention
The Patient Advocate for Cystic Fibrosis, Royal Brompton & Harefield NHS Trust, the Senior Research Fellow in Physiotherapy, Dr Jennifer Pryor, and Senior Medical Consultant of the Department of Cystic Fibrosis, Professor Margaret Hodson, have participated in the formulation of the proposal. Professor Margaret Hodson, Dr Khin Gyi and Dr Sarah Elkin have agreed that their patients may be invited to participate in the study when it has received ethical approval.
Hypothesis:
The inclusion of a series of physiotherapy joint and muscle movement techniques (musculoskeletal) techniques to current optimal care for the treatment of people with cystic fibrosis will lead to short term improvements in lung function, posture and exercise capacity.
Methodology:
1.Written informed consent will be obtained for all subjects before entering the study.
2.Up to twenty patients will be randomised to a control group, to continue with their normal optimal care, or to a treatment group where they will receive musculoskeletal physiotherapy sessions once a week, for six weeks, at Royal Brompton Hospital in addition to their current optimal care.
3. An independent observer (blind to the subject's randomisation) will, after consent is signed, collect the baseline data, undertake the tests for exercise capacity, the measurements for posture and chest wall mobility, and administer the qualitative questionnaires for pain and for quality of life related to physical functioning.
4.The independent observer will then undertake repeated measurements of lung function, exercise capacity, posture, chest wall mobility, and administer the qualitative questionnaires for pain and for quality of life related to physical functioning for all subjects at week three, six and twelve.
5. Full lung function tests will be undertaken in the Lung Function Laboratory (with the physiologist blind to the subject's randomisation) at baseline and after the six-week treatment period. When possible the subject's annual review lung function data will be used as the baseline measurement, to avoid duplication of these tests.
6. At the end point of the study subjects will be asked to complete a questionnaire.
The study will take place over twelve weeks from recruitment to final assessment. The
treatment and control groups will attend four times for a total of one hour for assessment.
The treatment group will also attend six treatment sessions which will take up to one hour. Two of those sessions will be on the same day as the independent measurements and will therefore take approximately two hours for the treatment group.
Statistical analysis:
The statistical analysis has been discussed with Mr Michael Roughton, Statistician, Royal Brompton & Harefield NHS Trust and Imperial College London and his advice taken.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
For the treatment group, outcome measures will be taken 30 minutes after treatment. For the control group these will be taken 15 to 30 minutes after arrival for assessment. The primary outcome measure will be forced expiratory volume in one second.
Secondary outcome measures
1. Other measures of lung function: forced vital capacity, peak expiratory flow rate, residual volume as a percent of total lung capacity
2. Modified shuttle test, monitoring oxygen saturation and heart rate and Borg CR10 scale of perceived exertion
3. Visual analogue scale for pain: a qualitative subjective assessment using a 10-centimeter scale
4. The Cystic Fibrosis Quality of Life Questionnaire, section one: physical functioning (Questionnaire I)
5. Flexi curve measurements of posture in standing
6. Chest wall excursion measurements using a tape measure for the circumference of the chest wall at axilla (armpit) and xiphisternal (lower chest) level
7. A questionnaire using a series of visual analogue scales with room for individual comment (Questionnaire II)
Overall trial start date
14/12/2006
Overall trial end date
09/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Added June 2008:
1. Reported postural changes, stiffness, discomfort and/or pain of musculoskeletal origin in the thoracic spine or chest wall
2. Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of >70mmol/l or sweat chloride of >60mmol/l)
3. Sixteen years of age or over
4. Patients in a stable clinical state with lung function at the time of entry that is within 10% of the mean of the last two recordings (separated by at least one month).
5. Forced Expiratory Volume in 1 second (FEV1) ≥30% predicted at time of entry to the study
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Added June 2008:
1. Evidence of a current respiratory exacerbation (worsening) as defined by Thornton et al. 2004
2. Cor pulmonale (right heart failure)
3. Low bone density (Z score < -3)(WHO Study Group 1994)
4. Previous history of spontaneous fractures
5. Past history of spinal fracture or other known arthopathic (joint) or spinal disease process
6. Currently undergoing musculoskeletal (physiotherapy, chiropractic or osteopathic) treatment
7. Pregnancy
8. Inability to give consent
9. Current enrolment in another research trial
Recruitment start date
14/12/2006
Recruitment end date
09/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Brompton & Harefield NHS Trust
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Brompton and Harefield NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
No External Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21820539
Publication citations
-
Results
Sandsund CA, Roughton M, Hodson ME, Pryor JA, Musculoskeletal techniques for clinically stable adults with cystic fibrosis: a preliminary randomised controlled trial., Physiotherapy, 2011, 97, 3, 209-217, doi: 10.1016/j.physio.2010.08.016.