- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240584
Exercise Prehabilitation of Breast Cancer (Prehab of BC)
The Impact of Exercise Prehabilitation on Upper Extremity Range of Motions, Functionality and Quality of Life in Breast Cancer Survivors: A Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Balıkesir, Turkey (Türkiye)
- Balikesir Ataturk City Hospital Affiliated with University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients diagnosed with breast cancer scheduled for surgical treatment
- Age ≥ 18 years
- Able to perform exercise
- Provided informed consent
Exclusion Criteria:
- Metastatic disease
- Prior upper limb injury or neurologic impairment
- Inability to comply with exercise program
- Postoperative chemotherapy before the 3rd month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single Group Assignment
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Range of Motion
Time Frame: baseline, 1st-3rd-6th-12th month
|
Measurement of Flexion, Abduction, Internal and External Rotation of Shoulder with goniometer
|
baseline, 1st-3rd-6th-12th month
|
|
Pain Intensity
Time Frame: baseline, 1st-3rd-6th-12th month
|
measure of pain with VAS (Visual analog scale)
|
baseline, 1st-3rd-6th-12th month
|
|
Functional Outcomes
Time Frame: baseline and 12th month
|
measure of upper extremity functions with UEFI-15 (Upper extremity functional index) instrument
|
baseline and 12th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fatigue
Time Frame: baseline and 12th month
|
measure of fatigue condition with FSS (Fatigue severity scale) instrument
|
baseline and 12th month
|
|
Quality of Life impairment
Time Frame: baseline and 12th month
|
measure of Quality of Life with EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire) instrument
|
baseline and 12th month
|
|
lymphedema
Time Frame: baseline and 12th month
|
Limb volume difference >10% or clinical signs of edema
|
baseline and 12th month
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Brahmbhatt P, Sabiston CM, Lopez C, et al. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020;10:571091. doi:10.3389/fonc.2020.571091
- Michael CM, Lehrer EJ, Schmitz KH, Zaorsky NG. Prehabilitation exercise therapy for cancer: A systematic review and meta-analysis. Cancer Med. 2021;10(13):4195-4205. doi:10.1002/cam4.4021
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHS Balikesir H PMR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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