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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)

23 juni 2026 bijgewerkt door: Royal College of Surgeons, Ireland

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

78

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Arnold Hill, MB, BCh, BAO, MCh, FRCSI
  • Telefoonnummer: +35318093000
  • E-mail: adkhill@rcsi.com

Studie Locaties

  • Ierland
    • Dublin
      • Beaumont, Dublin, Ierland, D09V2N0
        • Werving
        • Beaumont RCSI Cancer Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Control
standard post-operative care

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cardiorespiratory Fitness
Tijdsspanne: 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.
Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hand Grip Strength
Tijdsspanne: 6 months and 12 months post operatively
Measured using a hand dynamometer and reported in kilograms.
6 months and 12 months post operatively
Body Mass Index
Tijdsspanne: 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).
At six months and 12 months postoperatively
EQ5D5L Health Related Quality of Life
Tijdsspanne: 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)
At 6 months and 12 months post operatively
Percentage Body Fat
Tijdsspanne: 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 (%).
At 6 months and 12 months postoperatively
Muscle Mass
Tijdsspanne: At 6 months and 12 months postoperatively
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
Tijdsspanne: At 6 months and 12 months postoperatively
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
Tijdsspanne: Measured at 6 months and 1 year postoperatively.
Measured using the 30 second Sit to Stand Test
Measured at 6 months and 1 year postoperatively.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Royal College of Surgeons, Ireland

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2024

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 december 2028

Studieregistratiedata

Eerst ingediend

16 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 23-41

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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