An investigation into the relationship between full range arm and shoulder mobilisation and the incidence of lymphoedema.

ISRCTN	ISRCTN61345521
DOI	https://doi.org/10.1186/ISRCTN61345521
Secondary identifying numbers	N0436130486

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs J E Todd
Scientific

Macmillan Lymphodema Specialist Office
Cookridge Hospital
Leeds Teaching Hospitals NHS Trust
Hospital Lane
Leeds
LS16 6QB
United Kingdom

Phone	+44 (0)113 3924352
Email	r&d@leedsth.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To compare the incidence of lymphoedema development in breast cancer patients undertaking graded postoperative arm exercise compared to standard early full range shoulder exercise.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lymphoedema postmasectomy
Intervention	Randomised controlled trial Random allocation to: 1. Graded post-operative arm exercise 2. Standard early full range shoulder exercise
Intervention type	Other
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	01/04/2003
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients admitted for unilateral mastectomy and axillary node clearance who have been treated by the Breast Surgeons at Leeds General Infirmary (LGI).
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2003
Date of final enrolment	30/06/2005

Macmillan Lymphodema Specialist Office

Leeds
LS16 6QB
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008		Yes	No