| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN90285133 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0201189486 |
| Public title | A Pilot study: Do physiotherapy joint and muscle movement techniques improve forced expiratory volume in one second (FEV1) in adults with Cystic Fibrosis |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Cystic fibrosis |
| 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? |
| Design/methodology | Randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 15 out patients: 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 14/12/2006 |
| Anticipated end date | 13/12/2007 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | 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.
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. |
| Primary outcome measure(s) | 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 measure(s) | 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) |
| Sources of funding | Royal Brompton and Harefield NHS Trust
No External Funding
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mrs Catherine Alexandra Sandsund |
| Contact details | Royal Brompton & Harefield NHS Trust
Sydney Street
London
United Kingdom
SW3 6NP |
| Contact telephone | +44 020 7352 8121 (X4925) |
| Contact fax | +44 020 7351 8052 |
| Contact email | c.sandsund@ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN90285133 |
| Date last extracted from ISRCTN register | 17/04/2008 |
