A pilot study: do physiotherapy joint and muscle movement techniques improve forced expiratory volume in one second (FEV1) in adults with cystic fibrosis?

ISRCTN	ISRCTN90285133
DOI	https://doi.org/10.1186/ISRCTN90285133
Secondary identifying numbers	N0201189486

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 21/12/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Catherine Alexandra Sandsund
Scientific

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom

Phone	+44 020 7352 8121 (X4925)
Email	c.sandsund@ucl.ac.uk

Study information

Study design	Randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Approved by by Brompton, Harefield & NHLI Ethics Committee on 27/11/2006.REC reference number: 06/Q0404/81.
Health condition(s) or problem(s) studied	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
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 study start date	14/12/2006
Completion date	09/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	20
Key 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
Key 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
Date of first enrolment	14/12/2006
Date of final enrolment	09/07/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Brompton & Harefield NHS Trust

London
SW3 6NP
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Brompton and Harefield NHS Trust (UK)

No information available

No External Funding

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No