Trials / Completed
CompletedNCT07301580
Prehabilitation of Breast Cancer-Related Lymphedema
Physical Prehabilitation of Breast Cancer-Related Lymphedema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research · Other Government
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective prehabilitation study aims to evaluate the effects of an individualized exercise program initiated before breast cancer surgery and continued for 12 months postoperatively. The intervention focuses on incidence of breast cancer-related lymphedema, improving functional outcomes, range of motion, pain, and patient-reported measures throughout the surgical and recovery phases. Participants receive structured, personalized exercise instructions and are monitored regularly during follow-up. The study assesses the trajectory of extremity volume difference, early postoperative pain, the recovery pattern of shoulder range of motion and changes in functional status across the first postoperative year. Additionally, it examines the incidence of lymphedema and explores demographic and clinical determinants affecting patient outcomes. The findings are expected to provide evidence for the integration of prehabilitation into standard breast cancer care pathways.
Detailed description
This prospective prehabilitation study investigates the effectiveness of an individualized exercise program initiated before breast cancer surgery and radiation therapy maintained for 12 months postoperatively. The intervention was designed to optimize physical readiness for surgery, support early postoperative recovery, and promote long-term functional improvement. Participants received structured exercise instructions delivered through visual and written materials, and adherence was reinforced through regular follow-up contacts. The primary focus of the study is to characterize postoperative functional trajectories, including pain intensity, shoulder range of motion (ROM), upper-extremity function, and patient-reported outcomes. Particular emphasis is placed on the early postoperative period, during which pain typically increases and functional limitations become more pronounced. Longitudinal assessments allow observation of recovery patterns across all ROM planes, with anticipated improvements in flexion and abduction by the third postoperative month and further recovery in internal and external rotation by the sixth month. A secondary objective is to monitor the development of lymphedema, defined by limb volume differences and physical signs of edema. The study also explores demographic and clinical determinants that may influence treatment outcomes, aiming to identify subgroups that benefit most from prehabilitation. By evaluating functional, symptomatic, and quality-of-life outcomes across a 12-month period, this study provides evidence to support the incorporation of preoperative exercise interventions into standard breast cancer care pathways.
Conditions
- Breast Cancer-Related Arm Lymphedema
- Quality of Life Impairment
- Fatigue Syndrome, Chronic
- Prehabilitation
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Prehabilitation Exercise Group | A personalized upper-extremity exercise program initiated before surgery and continued for 12 months postoperatively. The program includes mobility, stretching, strengthening, and functional exercises tailored to individual needs. Instruction is provided through written and visual materials, with follow-up contacts to reinforce adherence. |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2025-10-05
- Completion
- 2025-10-05
- First posted
- 2025-12-24
- Last updated
- 2025-12-24
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07301580. Inclusion in this directory is not an endorsement.