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 (EXERCISE DIEP)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Exercise
• Intervention / Treatment: Behavioral: Structured individualised 12-week post operative exercise programme

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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aisling Hegarty, PhD; Phone Number: 018093000; Email: Aislinghegarty@rcsi.ie
• Study Contact Backup: Name: Arnold Hill, MB, BCh, BAO, MCh, FRCSI; Phone Number: +35318093000; Email: adkhill@rcsi.com

Study Locations

• Ireland
  • Dublin
    • Beaumont, Dublin, Ireland, D09V2N0
      • Recruiting
      • Beaumont RCSI Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged 18 years and older

2. Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:

   1. Genetic mutation carriers undergoing risk-reducing mastectomy.
   2. Ductal carcinoma in situ (DCIS) requiring mastectomy.
   3. Early invasive breast cancer requiring mastectomy.
   4. 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).
3. Candidates for breast reconstruction with DIEP.
4. Fluent in English
5. Fit for general anaesthetic Signed informed consent form

Exclusion Criteria:

1. Advanced breast cancer with skin involvement.
2. Undergoing bilateral DIEP reconstruction or other forms of breast reconstruction (e.g., TRAM, implant-based, LD flap).
3. Pregnancy
4. Lactation Patients with insufficient English to sign an informed consent (i.e. interpreter required).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; standard post-operative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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.

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Breast cancer; DIEP Reconstruction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity
• Other Study ID Numbers: 23-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No