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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aisling Hegarty, PhD
- Numéro de téléphone: 018093000
- E-mail: Aislinghegarty@rcsi.ie
Sauvegarde des contacts de l'étude
- Nom: Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- Numéro de téléphone: +35318093000
- E-mail: adkhill@rcsi.com
Lieux d'étude
-
-
Dublin
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Beaumont, Dublin, Irlande, D09V2N0
- Recrutement
- Beaumont RCSI Cancer Centre
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Aucune intervention: Control
standard post-operative care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiorespiratory Fitness
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hand Grip Strength
Délai: 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
Délai: 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
Délai: 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)
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At 6 months and 12 months post operatively
|
|
Percentage Body Fat
Délai: At 6 months and 12 months postoperatively
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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
Délai: 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
Délai: 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
Délai: Measured at 6 months and 1 year postoperatively.
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Measured using the 30 second Sit to Stand Test
|
Measured at 6 months and 1 year postoperatively.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23-41
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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