Breast CancerEXERCISE DIEPNCT07672392
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
A study testing Structured individualised 12-week post operative exercise programme in people with Breast Cancer and Exercise, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Exercise
- What is being tested?
- Structured individualised 12-week post operative exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- Candidates for breast reconstruction with DIEP.
- Fluent in English
- Fit for general anaesthetic Signed informed consent form
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Exercise
- Being tested
- Structured individualised 12-week post operative exercise programme
- Keywords
- Breast cancer, DIEP Reconstruction, Exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured individualised 12-week post operative exercise programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Structured individualised 12-week post operative exercise programme |
| Control | No intervention | standard post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively
Secondary outcomes (7)
Hand Grip Strength
Measured using a hand dynamometer and reported in kilograms.
Measured: 6 months and 12 months post operatively
Body Mass Index
Body mass index (BMI) calculated from measured weight and height and reported in kilograms per square meter (kg/m²).
Measured: At six months and 12 months postoperatively
EQ5D5L Health Related Quality of Life
Quality of Life and Psychosocial Health: Assessed using the BREAST-Q (psychosocial and sexual well-being domains)
Measured: At 6 months and 12 months post operatively
Percentage Body Fat
Percentage body fat measured using bioelectrical impedance analysis with a Tanita device and reported as percentage body fat (%).
Measured: At 6 months and 12 months postoperatively
Muscle Mass
Muscle mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).
Measured: At 6 months and 12 months postoperatively
Bone Mass
Bone mass measured using bioelectrical impedance analysis with a Tanita device and reported in kilograms (kg).
Measured: At 6 months and 12 months postoperatively
Lower Limb Strength
Measured using the 30 second Sit to Stand Test
Measured: Measured at 6 months and 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Aug 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672392
- Sponsor's protocol ID
- 23-41
- Acronym
- EXERCISE DIEP
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07672392
- Acronym / sponsor ID
- EXERCISE DIEP / 23-41
- Conditions
- Breast Cancer, Exercise
- Keywords
- Breast cancer, DIEP Reconstruction, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Structured individualised 12-week post operative exercise programmeStructured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom. |
| Control | No intervention | –standard post-operative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Candidates for breast reconstruction with DIEP.
- Fluent in English
- Fit for general anaesthetic Signed informed consent form
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured individualised 12-week post operative exercise programmeStructured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom. | Behavioural | Intervention |
Primary outcome
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.
7 secondary outcomes
Hand Grip Strength
Time frame: 6 months and 12 months post operatively
Body Mass Index
Time frame: At six months and 12 months postoperatively
EQ5D5L Health Related Quality of Life
Time frame: At 6 months and 12 months post operatively
Percentage Body Fat
Time frame: At 6 months and 12 months postoperatively
Muscle Mass
Time frame: At 6 months and 12 months postoperatively
Bone Mass
Time frame: At 6 months and 12 months postoperatively
Lower Limb Strength
Time frame: Measured at 6 months and 1 year postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as this could potentially identify participants. Anonymous datasets will be available for validation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured individualised 12-week post operative exercise programme in people with Breast Cancer and Exercise, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnold Hill, MB, BCh, BAO, MCh, FRCSI (+35318093000, adkhill@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.