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NCT Number: NCT07672392

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Exercise Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Cardiorespiratory Fitness

    Time frame: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively

    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

  1. Hand Grip Strength

    Time frame: 6 months and 12 months post operatively

    Measured using a hand dynamometer and reported in kilograms.

  2. Body Mass Index

    Time frame: At six months and 12 months postoperatively

    Body mass index (BMI) calculated from measured weight and height and reported in kilograms per square meter (kg/m²).

  3. EQ5D5L Health Related Quality of Life

    Time frame: At 6 months and 12 months post operatively

    Quality of Life and Psychosocial Health: Assessed using the BREAST-Q (psychosocial and sexual well-being domains)

  4. Percentage Body Fat

    Time frame: At 6 months and 12 months postoperatively

    Percentage body fat measured using bioelectrical impedance analysis with a Tanita device and reported as percentage body fat (%).

  5. Muscle Mass

    Time frame: At 6 months and 12 months postoperatively

    Muscle mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).

  6. Bone Mass

    Time frame: At 6 months and 12 months postoperatively

    Bone mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).

  7. Lower Limb Strength

    Time frame: Measured at 6 months and 1 year postoperatively.

    Measured using the 30 second Sit to Stand Test

Study contacts

Contact information is provided by the study sponsor or research team.

Aisling Hegarty, PhD

CONTACT

[email protected]

018093000

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

CONTACT

[email protected]

+35318093000

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Acronym: EXERCISE DIEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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