Skip to main content
Clinical Trials/NCT06552650
NCT06552650
Recruiting
Not Applicable

Randomized Controlled Study to Evaluate the Effect of Early Exercise on Functional Restoration of Exercise and Surgical Outcomes After Breast Reconstruction

Yonsei University1 site in 1 country72 target enrollmentNovember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Braest Cancer
Sponsor
Yonsei University
Enrollment
72
Locations
1
Primary Endpoint
Shoulder Strength
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Breast reconstruction is an important step and option after mastectomy and can help improve the quality of life of breast cancer patients. Therefore, the proportion of patients undergoing breast reconstruction in conjunction with mastectomy is steadily increasing. Despite recent advances in less invasive techniques, postoperative movement restrictions are unavoidable, and these postoperative pain or functional limitations can last for months to years. Patients most often experience a decrease in shoulder function, which negatively impacts their physical function and is an important factor in their ability to perform activities of daily living. Early postoperative exercise has been proven to have positive results in promoting the recovery of shoulder function in breast cancer patient. However, there is a lack of research on the effectiveness of early postoperative exercise in the context of breast reconstruction. Therefore, this study aims to evaluate the effect of early postoperative exercise on patients' shoulder and trunk function after breast reconstruction.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult women between the ages of 19 and 70
  • Pathologically diagnosed with breast cancer
  • Scheduled to undergo unilateral or bilateral mastectomy and breast reconstruction

Exclusion Criteria

  • Adult women age 70 and order who have been diagnosed with breast cancer
  • Had surgery or radiation therapy to the same side of the armpit
  • Scheduled to undergo or have undergone delyed breast reconstruction
  • Have breast cancer that has spread to other cancers or is metastatic
  • Deemed by the healthcare provider to have unmeasurable postoperative complications (seroma, laceration, lymphedema observed within 1 month of surgery)
  • Have problems reading or understanding Korean or have problems communicating with the researcher
  • Have difficulty exercising as judged by the healthcare provider

Outcomes

Primary Outcomes

Shoulder Strength

Time Frame: "1 Day before surgery", "5 Days after Surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

Shoulder Strength: Objectively measures shoulder strength (in newton) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension.

Trunk Strength

Time Frame: "1 Day before surgery", "5 Days after Surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

Trunk Strength: Objectively measures trunk flexion strength (in newton).

Shoulder Range of Motion

Time Frame: "1 Day before surgery", "5 Days after Surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

Shoulder Range of Motion: Objectively measures shoulder range of motion (in degree) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension.

Trunk Range of Motion

Time Frame: "1 Day before surgery", "5 Days after Surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

Trunk Range of Motion: Objectively measures trunk extension range of motion (in degree).

Secondary Outcomes

  • Body fat("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")
  • Postoperative Satisfaction after Breast reconstruction("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")
  • Weight("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")
  • BMI("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")
  • Shoulder Pain and Disability("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")
  • Muscle mass("1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery")

Study Sites (1)

Loading locations...

Similar Trials