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 |
| Protocol serial number | N0436130486 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 21/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs J E Todd
Scientific
Scientific
Macmillan Lymphodema Specialist Office
Cookridge Hospital
Leeds Teaching Hospitals NHS Trust
Hospital Lane
Leeds
LS16 6QB
United Kingdom
| Phone | +44 (0)113 3924352 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Height |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Macmillan Lymphodema Specialist Office
Leeds
LS16 6QB
United Kingdom
LS16 6QB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/12/2008 | Yes | No |
