Prehabilitation in Breast Cancer Surgery

February 23, 2026 updated by: Demet Ferahman, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development

This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer surgery is associated with postoperative morbidity including shoulder dysfunction, pain, fatigue, and lymphedema. Prehabilitation aims to optimize functional capacity before surgery and may reduce postoperative complications.

This single-center randomized controlled trial will enroll 54 women with stage I-III invasive breast cancer scheduled for mastectomy or breast-conserving surgery. Participants will be randomized to:

  1. Home-based structured prehabilitation program
  2. Usual preoperative care

Primary endpoints are shoulder range of motion (goniometric measurement) and DASH score changes across multiple time points. Participants will be followed for up to 24 months for lymphedema development.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34140
        • Dr. Sadi Konuk Bakirkoy Training and Health Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Women aged 18-80

Stage I-III invasive breast cancer

Scheduled for surgery

≥3 weeks before surgery

No neoadjuvant therapy

Exclusion Criteria:

Exercise contraindication

Active shoulder pathology

Severe cardiopulmonary disease

Planned neoadjuvant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation Group

Participants will receive a structured home-based prehabilitation program delivered through written materials and instructional exercise videos (QR code access). The program includes:

Aerobic training (3/week, 30-40 minutes, RPE 4-6) Upper extremity resistance exercises (3 days/week, 3 sets of 10 repetitions) Mobility and stretching exercises

Adherence will be monitored through weekly remote follow-up (telephone)
Other: Home-Based Prehabilitation Exercise Program

Participants assigned to this arm will receive a structured, home-based prehabilitation program initiated at least three weeks prior to surgery. The intervention includes: (1) moderate-intensity aerobic exercise (3 sessions per week, 30 minutes per session, target intensity RPE 4-6/10), (2) upper extremity resistance exercises using elastic bands (3 sessions per week, 3 sets of 10 repetitions per exercise), and (3) mobility and stretching exercises focused on shoulder function.

The program will be delivered through written materials and instructional exercise videos accessible via QR code. Participants will receive elastic resistance bands for training. Adherence and progression will be monitored weekly via remote follow-up (telephone or email contact). The intervention is non-pharmacological and designed to optimize upper extremity function prior to breast cancer surgery.
Active Comparator: Usual Care
Standard preoperative counseling without structured exercise prescription.
Other: Usual Care
Usual Preoperative Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Shoulder Range of Motion (degrees)
Time Frame: Baseline to 12 weeks post-op
Measured by goniometer
Baseline to 12 weeks post-op
DASH Score
Time Frame: Baseline to 12 weeks post-op
Change in DASH Score The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item patient-reported outcome measure assessing upper extremity disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.
Baseline to 12 weeks post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Baseline to 12 weeks post-op
Grip Strength in kgs
Baseline to 12 weeks post-op
Pain (Brief Pain Inventory - BPI)
Time Frame: baseline to 12 weeks
Pain severity and pain-related interference will be assessed using the Brief Pain Inventory (BPI). The BPI evaluates pain intensity (0-10 numeric rating scale) and its impact on daily functioning. Higher scores indicate greater pain severity and interference.
baseline to 12 weeks
Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)
Time Frame: 0-12 months
Cancer-related fatigue will be measured using the FACT-F questionnaire. The scale consists of 13 items scored from 0 to 4, with total scores ranging from 0 to 52. Lower scores indicate greater fatigue severity.
0-12 months
Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Time Frame: baseline to 12 weeks
Functional disability will be assessed using the 12-item interviewer-administered WHODAS 2.0. Total scores range from 0 to 48, with higher scores indicating greater disability and functional impairment.
baseline to 12 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Time Frame: baseline to 12 weeks
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), consisting of 14 items divided into anxiety (HADS-A) and depression (HADS-D) subscales. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.
baseline to 12 weeks
Lymphedema Incidence
Time Frame: baseline to 2 years postop
Upper extremity lymphedema will be assessed using circumferential limb measurements at standardized anatomical points. Lymphedema will be defined as a ≥2 cm inter-limb difference or ≥10% volume difference compared to the contralateral arm, confirmed by clinical evaluation. Outcome will be reported as incidence (yes/no).
baseline to 2 years postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Sadi Konuk Bakirkoy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and local regulations governing patient privacy. De-identified data may be available upon reasonable request and subject to ethics committee approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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