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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aisling Hegarty, PhD
- 電話番号：018093000
- メール：Aislinghegarty@rcsi.ie
研究連絡先のバックアップ
- 名前：Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- 電話番号：+35318093000
- メール：adkhill@rcsi.com
研究場所
-
-
Dublin
-
Beaumont、Dublin、アイルランド、D09V2N0
- 募集
- Beaumont RCSI Cancer Centre
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：Control
standard post-operative care
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiorespiratory Fitness
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hand Grip Strength
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Bone Mass
時間枠：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
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 23-41
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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