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All patients undergoing mastectomy for breast cancer should be offered the option of reconstructive surgery. The Deep Inferior Epigastric Perforator Flap or DIEP reconstruction as it is commonly referred to, is becoming the favoured reconstruction by both patients and surgeons as it gives a great cosmetic outcome as well as being a good option for patients who may have to undergo radiotherapy treatment after their surgery.
Exercise has been demonstrated in previous research to improve tolerance of treatment (particularly chemotherapy), post operative fatigue and the overall quality of life in patients undergoing cancer treatment. Furthermore, it has shown to improve survival in patients who are being treated for breast cancer. The investigators are undertaking this study to investigate whether a structured exercise programme will improve patients fitness after surgery and ultimately improve their recovery after their reconstructive surgery. To do this, half of the people taking part will be undertaking a structured exercise programme and the other half will not and will be assessing which group recover better after their surgery. Currently, no breast reconstruction patients in Ireland are receiving a formal "exercise prescription" after their surgery so will be looking to see if this helps people recover better before it is made standard care for every breast patient in Ireland.
Primary Objective:
To evaluate the impact of a structured, post-operative exercise programme on patient-reported and functional outcomes following DIEP flap breast reconstruction.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Structured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom. |
|
| Control | No Intervention | standard post-operative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured individualised 12-week post operative exercise programme | Behavioral | Structured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory Fitness | Cardiorespiratory fitness measured using the 6-Minute Walk Test (6MWT). Outcome reported as change in distance walked (metres) from baseline to 6 months post-operatively. Greater distance indicates improved cardiorespiratory fitness. | Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength | Measured using a hand dynamometer and reported in kilograms. | 6 months and 12 months post operatively |
| Body Mass Index | Body mass index (BMI) calculated from measured weight and height and reported in kilograms per square meter (kg/m²). |
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Inclusion Criteria:
Women aged 18 years and older
Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:
Candidates for breast reconstruction with DIEP.
Fluent in English
Fit for general anaesthetic Signed informed consent form
Exclusion Criteria:
This study is post DIEP breast reconstruction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnold Hill, MB, BCh, BAO, MCh, FRCSI | Contact | +35318093000 | adkhill@rcsi.com | |
| Aisling Hegarty, PhD | Contact | 018093000 | Aislinghegarty@rcsi.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont RCSI Cancer Centre | Recruiting | Beaumont | Dublin | D09V2N0 | Ireland |
Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.
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This is a randomised control trial that seeks to evaluate the impact of a structured, post-operative exercise programme on patient-reported and functional outcomes following DIEP flap breast reconstruction.
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| At six months and 12 months postoperatively |
| EQ5D5L Health Related Quality of Life | Quality of Life and Psychosocial Health: Assessed using the BREAST-Q (psychosocial and sexual well-being domains) | At 6 months and 12 months post operatively |
| Percentage Body Fat | Percentage body fat measured using bioelectrical impedance analysis with a Tanita device and reported as percentage body fat (%). | At 6 months and 12 months postoperatively |
| Muscle Mass | Muscle mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg). | At 6 months and 12 months postoperatively |
| Bone Mass | Bone mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg). | At 6 months and 12 months postoperatively |
| Lower Limb Strength | Measured using the 30 second Sit to Stand Test | Measured at 6 months and 1 year postoperatively. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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