Clinical trial NCT06552650: Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction
Official title: Randomized Controlled Study to Evaluate the Effect of Early Exercise on Functional Restoration of Exercise and Surgical Outcomes After Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Braest Cancer
Breast Reconstruction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 72
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Shoulder Range of Motion
timeFrame: "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"
measure: Shoulder Strength
timeFrame: "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"
measure: Trunk Range of Motion
timeFrame: "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"
measure: Trunk Strength
timeFrame: "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"
Secondary outcomes:
measure: Weight
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
measure: BMI
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
measure: Body fat
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
measure: Muscle mass
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
measure: Shoulder Pain and Disability
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
measure: Postoperative Satisfaction after Breast reconstruction
timeFrame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
Study officials:
References: