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

NCT07672392 | Recruiting DMC

• 1 other identifier: 23-41
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Exercise

Keywords

Breast cancer; DIEP Reconstruction; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hand Grip Strength

  6 months and 12 months post operatively

• Body Mass Index

  At six months and 12 months postoperatively

• EQ5D5L Health Related Quality of Life

  At 6 months and 12 months post operatively

• Percentage Body Fat

  At 6 months and 12 months postoperatively

• Muscle Mass

  At 6 months and 12 months postoperatively

Study Arms (2)

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.

Behavioral: Structured individualised 12-week post operative exercise programme

Control

NO INTERVENTION

standard post-operative care

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is post DIEP breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Central Study Contacts

Arnold Hill, MB, BCh, BAO, MCh, FRCSI

CONTACT

+35318093000; adkhill@rcsi.com

Aisling Hegarty, PhD

CONTACT

018093000; Aislinghegarty@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)