An investigation into the relationship between postoperative arm and shoulder mobilisation exercises and the incidence of lymphoedema
| ISRCTN | ISRCTN38946256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38946256 |
| Protocol serial number | PRF/02/1 |
| Sponsor | Physiotherapy Research Foundation (UK) |
| Funder | Physiotherapy Research Foundation (Ref: PRF/02/1) |
- Submission date
- 02/07/2003
- Registration date
- 02/07/2003
- Last edited
- 29/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jacquelyne Todd
Scientific
Scientific
Lymphoedema Department
Wharfedale Hospital
Newall Carr Road
Otley
Leeds
LS21 2LY
United Kingdom
| Phone | +44 (0)113 3921807 |
|---|---|
| Jacquelyne.Todd@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised comparative trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised comparative trial of two programmes of shoulder exercise following axillary node dissection for invasive breast cancer |
| Study acronym | LASER (Leeds Axillary Surgery Exercise Research) |
| Study objectives | Please note that, as of 19/06/2008, this trial record was extensively amended. Most of the changes can be found in the relevant field. The following changes have also been made: 1. Scientific trial title was added 2. Study hypothesis was added 3. Anticipated end date has been updated from 31/12/2003 to 31/12/2007 Study hypothesis: There is a reduced incidence of lymphoedema after post-operative exercise that delays full shoulder mobilisation for one week. |
| Ethics approval(s) | Added as of 19/06/2008: This study was approved by the West Leeds Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Breast cancer related lymphoedema |
| Intervention | Interventions amended as of 19/06/2008: Intervention group will receive a shoulder mobilisation programme that is characterised by a delayed commencement of full range gleno-humeral exercises following the removal of the axillary drain. Control group will receive the current standard exercise regimen which commences full range gleno-humeral exercises from the first post-operative day. Measurements for both groups are pre-operatively and at one year, with structured telephone questionnaires at one week, one month and six months. Previous interventions: Intervention group will receive a shoulder mobilisation programme that is characterised by a delayed commencement of full range gleno-humeral exercises following the removal of the axillary drain. Control group will receive the current standard exercise regimen which commences full range gleno-humeral exercises from the first post-operative day. Measurements for both groups are pre-operatively, one month, six months and one year. |
| Intervention type | Other |
| Primary outcome measure(s) |
Added as of 19/06/2008: |
| Key secondary outcome measure(s) |
Added as of 19/06/2008: |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 104 |
| Key inclusion criteria | Patients who are undergoing axillary surgery followed by radiotherapy for unilateral primary breast cancer with axillary node involvement. |
| Key exclusion criteria | Added as of 26/06/2008: 1. Women under eighteen years 2. Existing history of breast cancer 3. Prior axillary surgery or irradiation 4. Pre-existing lymphoedema as measured by a difference in 200 mls between the two arms when measured pre-operatively using the volume displacement method 5. Women requiring full time cognitive or physical care |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Lymphoedema Department
Leeds
LS21 2LY
United Kingdom
LS21 2LY
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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
