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 |
| Secondary identifying numbers | 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
| Study design | Randomised comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Added as of 19/06/2008: 1. Limb volume using water displacement method |
| Secondary outcome measures | Added as of 19/06/2008: 1. Range of movement using goniometer 2. Hand grip strength using dynamometer 3. Health related quality of life using FACTB+4, Shoulder Disability Questionnaire |
| Overall study start date | 01/01/2003 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Added as of 19/06/2008: 104 participants (52 per group) |
| 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
- England
- United Kingdom
Study participating centre
Lymphoedema Department
Leeds
LS21 2LY
United Kingdom
LS21 2LY
United Kingdom
Sponsor information
Physiotherapy Research Foundation (UK)
Charity
Charity
The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom
| Phone | +44 (0)20 7306 6601 |
|---|---|
| attewm@csp.org.uk | |
| Website | http://www.csp.org.uk |
"ROR" |
https://ror.org/04sn78z72 |
Funders
Funder type
Charity
Physiotherapy Research Foundation (Ref: PRF/02/1)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
