About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years and older
Genetic mutation carriers undergoing risk-reducing mastectomy.
Ductal carcinoma in situ (DCIS) requiring mastectomy.
Early invasive breast cancer requiring mastectomy.
Disqualifiers
Advanced breast cancer with skin involvement.
Undergoing bilateral DIEP reconstruction or other forms of breast reconstruction (e.g., TRAM, implant-based, LD flap).
Pregnancy
Lactation Patients with insufficient English to sign an informed consent (i.e. interpreter required).
Trial design
Parallel
Treatments tested in this trial
Structured individualised 12-week post operative exercise programme
BehavioralStructured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Hand Grip Strength
Measured using a hand dynamometer and reported in kilograms.
Body Mass Index
Body mass index (BMI) calculated from measured weight and height and reported in kilograms per square meter (kg/m²).
EQ5D5L Health Related Quality of Life
Quality of Life and Psychosocial Health: Assessed using the BREAST-Q (psychosocial and sexual well-being domains)
Percentage Body Fat
Percentage body fat measured using bioelectrical impedance analysis with a Tanita device and reported as percentage body fat (%).
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