An interventional study of Structured individualised 12-week post operative exercise programme in Breast Cancer and Exercise, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Supportive care
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:
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 78 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Structured individualised 12-week post operative exercise programme
standard post-operative care
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.
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.
Time frame: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively
Hand Grip Strength
Measured using a hand dynamometer and reported in kilograms.
Time frame: 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).
Time frame: 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)
Time frame: 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 (%).
Time frame: 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).
Time frame: 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).
Time frame: At 6 months and 12 months postoperatively
Lower Limb Strength
Measured using the 30 second Sit to Stand Test
Time frame: Measured at 6 months and 1 year postoperatively.
Plan to share: No — Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2027, 40 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 40 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Royal College of Surgeons, Ireland