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This single-center, parallel-group randomized controlled trial (RCT) will compare two timings for initiating specific exercise therapy after breast cancer surgery. The study tests whether early initiation (within the first postoperative week) versus delayed initiation (at 3 weeks postoperative) results in superior upper limb function at 6 months as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcomes include pain intensity (Visual Analog Scale, VAS) and wound-related complications such as drainage time and hematoma incidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Initiation of Specific Exercise Therapy | Experimental | In this group, participants will initiate specific exercise therapy within the first postoperative week. They will receive 40-minute supervised sessions twice weekly for 8 weeks, with a transition to a prescribed home-based maintenance program for an additional 4 months. |
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| Delayed Initiation of Specific Exercise Therapy | Experimental | Participants in this group will begin the same specific exercise therapy protocol at 3 weeks postoperative. Otherwise, the intervention is identical to that provided to the Early Therapy group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Exercise Therapy | Behavioral | The exercise protocol includes mobilisation and stretching with 40-minute sessions twice weekly for 8 weeks post-initiation, transitioning to a home-based maintenance phase for 4 months. All sessions will be supervised by certified physiotherapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Limb Function (DASH Questionnaire) | The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated measure of upper limb function. The questionnaire is scored on a continuous scale ranging from 0 to 100, where 0 indicates no disability and 100 represents the most severe disability. Lower scores indicate better upper limb function. | Assessed preoperatively (baseline) and at 6 months postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (Visual Analog Scale - VAS) | A 0-100 VAS will measure patient-reported pain levels, where 0 signifies no pain and 100 the worst pain imaginable. | Assessed at baseline and at 1, 3, and 6 months postoperative. |
| Wound-Related Complications - Drainage Time (Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed ElMeligie, Ph.D | Contact | 01159880001 | +20 | mohamed.elmeligie@ahuc.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Al Hayah University | Recruiting | Cairo | 12311 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Eligible women will be randomly assigned to either the early or delayed specific exercise therapy initiation group. The interventions will be identical aside from the timing; both groups will receive supervised exercise sessions and subsequent home maintenance.
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Given the nature of the intervention timing, participants, care providers, and investigators are unblinded; however, those assessing the primary and secondary outcomes will be blinded to treatment group.
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The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications. |
| Monitored during the immediate postoperative period up to 3 months. |
| Wound-Related Complications - Incidence of Hematoma | The occurrence of hematoma will be documented as a binary outcome (presence or absence) for each patient. The incidence will be calculated as the proportion of patients developing hematoma during the monitoring period. | Monitored during the immediate postoperative period up to 3 months. |
| D017437 |
| Skin and Connective Tissue Diseases |