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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aisling Hegarty, PhD
- Número de teléfono: 018093000
- Correo electrónico: Aislinghegarty@rcsi.ie
Copia de seguridad de contactos de estudio
- Nombre: Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- Número de teléfono: +35318093000
- Correo electrónico: adkhill@rcsi.com
Ubicaciones de estudio
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Dublin
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Beaumont, Dublin, Irlanda, D09V2N0
- Reclutamiento
- Beaumont RCSI Cancer Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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Sin intervención: Control
standard post-operative care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiorespiratory Fitness
Periodo de tiempo: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively
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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.
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Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hand Grip Strength
Periodo de tiempo: 6 months and 12 months post operatively
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Measured using a hand dynamometer and reported in kilograms.
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6 months and 12 months post operatively
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|
Body Mass Index
Periodo de tiempo: At six months and 12 months postoperatively
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Body mass index (BMI) calculated from measured weight and height and reported in kilograms per square meter (kg/m²).
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At six months and 12 months postoperatively
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EQ5D5L Health Related Quality of Life
Periodo de tiempo: At 6 months and 12 months post operatively
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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
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Percentage Body Fat
Periodo de tiempo: 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 (%).
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At 6 months and 12 months postoperatively
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Muscle Mass
Periodo de tiempo: At 6 months and 12 months postoperatively
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Muscle mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).
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At 6 months and 12 months postoperatively
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Bone Mass
Periodo de tiempo: At 6 months and 12 months postoperatively
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Bone mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).
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At 6 months and 12 months postoperatively
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Lower Limb Strength
Periodo de tiempo: Measured at 6 months and 1 year postoperatively.
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Measured using the 30 second Sit to Stand Test
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Measured at 6 months and 1 year postoperatively.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23-41
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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