NCT07240584

Brief Summary

This prospective prehabilitation trial evaluated the effectiveness of an individualized exercise program initiated before breast cancer surgery and maintained for 12 months. The intervention aimed to promote functional recovery and improve patient-reported outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Breast CancerShoulder DysfunctionQuality of LifePostoperative RecoveryFatigueLymphedema

Keywords

exercise prehabilitationbreast cancerupper extremity functionalityquality of life

Outcome Measures

Primary Outcomes (3)

  • Shoulder Range of Motion

    Measurement of Flexion, Abduction, Internal and External Rotation of Shoulder with goniometer

    baseline, 1st-3rd-6th-12th month

  • Pain Intensity

    measure of pain with VAS (Visual analog scale)

    baseline, 1st-3rd-6th-12th month

  • Functional Outcomes

    measure of upper extremity functions with UEFI-15 (Upper extremity functional index) instrument

    baseline and 12th month

Secondary Outcomes (3)

  • fatigue

    baseline and 12th month

  • Quality of Life impairment

    baseline and 12th month

  • lymphedema

    baseline and 12th month

Study Arms (1)

Single Group Assignment

OTHER
Behavioral: Exercise-Based Prehabilitation Program

Interventions

Exercise-Based Prehabilitation ProgramBEHAVIORAL

The exercise program was delivered to patients through both visual and written materials, accompanied by face-to-face training sessions conducted by a physiotherapist. A home-based program was designed separately for the pre-surgery phase, postoperative day 1, day 3, day 7, and the maintenance period. The exercise template included postural correction, breathing, aerobic, stretching, and resistive strengthening exercises targeting muscles in adjacent to the shoulder joint and mobilization of scapulothoracic complex via stretching and strengthening exercises of periscapular muscles.

Single Group Assignment

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients diagnosed with breast cancer scheduled for surgical treatment
  • Age ≥ 18 years
  • Able to perform exercise
  • Provided informed consent

You may not qualify if:

  • Metastatic disease
  • Prior upper limb injury or neurologic impairment
  • Inability to comply with exercise program
  • Postoperative chemotherapy before the 3rd month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir Ataturk City Hospital Affiliated with University of Health Sciences

Balıkesir, Turkey (Türkiye)

Location

Related Publications (3)

  • Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.

    PMID: 33072603RESULT

  • Michael CM, Lehrer EJ, Schmitz KH, Zaorsky NG. Prehabilitation exercise therapy for cancer: A systematic review and meta-analysis. Cancer Med. 2021 Jul;10(13):4195-4205. doi: 10.1002/cam4.4021. Epub 2021 Jun 10.

    PMID: 34110101RESULT

  • Alicia DRJ, Manuel GS, Ignacio CVA. Physical prehabilitation in patients with breast cancer: a systematic review. Support Care Cancer. 2025 Jan 6;33(1):71. doi: 10.1007/s00520-024-09122-w.

    PMID: 39757306RESULT

MeSH Terms

Conditions

Breast NeoplasmsFatigueLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 21, 2025

Study Start

October 25, 2024

Primary Completion

November 2, 2025

Study Completion

November 2, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations

TU(1)