The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured individualised 12-week post operative exercise programme.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Exercise. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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:
* To examine the effects of the exercise programme on upper and lower limb strength, body composition (BMI, fat and muscle mass, bone density), and functional recovery. * To evaluate the influence of exercise on post-operative complication rates, length of hospital stay and time to return to daily activities. * To explore changes in psychological health and body image perception using validated questionnaires. * To assess adherence, feasibility, and safety of the structured exercise programme within a breast reconstruction population. * To perform an exploratory health-economic analysis comparing the costs and potential healthcare savings associated with the intervention versus standard care.
Interventions
- Behavioral Structured individualised 12-week post operative exercise programme
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.
Primary outcome measures
- Cardiorespiratory Fitness [Time frame: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively]
Secondary outcome measures (7)
- Hand Grip Strength [Time frame: 6 months and 12 months post operatively]
- Body Mass Index [Time frame: At six months and 12 months postoperatively]
- EQ5D5L Health Related Quality of Life [Time frame: At 6 months and 12 months post operatively]
- Percentage Body Fat [Time frame: At 6 months and 12 months postoperatively]
- Muscle Mass [Time frame: At 6 months and 12 months postoperatively]
- Bone Mass [Time frame: At 6 months and 12 months postoperatively]
- Lower Limb Strength [Time frame: Measured at 6 months and 1 year postoperatively.]
Eligibility criteria
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:
- Genetic mutation carriers undergoing risk-reducing mastectomy.
- Ductal carcinoma in situ (DCIS) requiring mastectomy.
- Early invasive breast cancer requiring mastectomy.
- The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or pectoralis major muscle (as proven on MRI).
- Candidates for breast reconstruction with DIEP.
- Fluent in English
- Fit for general anaesthetic Signed informed consent form
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Ireland · 1 center
- Beaumont RCSI Cancer Centre — Beaumont
Identifiers
NCT: NCT07672392 · 23-41