|
ISRCTN
|
ISRCTN61345521
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
An investigation into the relationship between full range arm and shoulder mobilisation and the incidence of lymphoedema.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0436130486
|
|
Study hypothesis
|
To compare the incidence of lymphoedema development in breast cancer patients undertaking graded postoperative arm exercise compared to standard early full range shoulder exercise.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Lymphoedema postmasectomy
|
|
Participants - inclusion criteria
|
Patients admitted for unilateral mastectomy and axillary node clearance who have been treated by the Breast Surgeons at Leeds General Infirmary (LGI).
|
|
Participants - exclusion criteria
|
Does not meet inclusion criteria
|
|
Anticipated start date
|
01/04/2003
|
|
Anticipated end date
|
30/06/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Randomised controlled trial
Random allocation to:
1. Graded post-operative arm exercise
2. Standard early full range shoulder exercise
|
|
Primary outcome measure(s)
|
1. Height
2. Weight
3. Limb volume
4. Truncal oedema
5. Range of movement at the gleno-humeral joint
6. Arm swelling
7. Truncal swelling
8. Measurement of shoulder mobility
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Leeds Teaching Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mrs
J E
Todd
|
|
Address
|
Macmillan Lymphodema Specialist Office
Cookridge Hospital
Leeds Teaching Hospitals NHS Trust
Hospital Lane
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS16 6QB
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)113 3924352
|
|
Fax
|
+44 (0)113 3924143
|
|
Email
|
r&d@leedsth.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health,
Richmond House,
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
06/10/2009
|
|
Date ISRCTN assigned
|
30/09/2004
|
