Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction
NCT Number: NCT06552650
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Braest Cancer|Breast Reconstruction
Interventions: BEHAVIORAL: Exercise|OTHER: Usual Care
Sponsor: Yonsei University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-11-20
Completion Date: 2025-06-30
Locations: Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital, Seoul, 03722, Korea, Republic of

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.

Primary Outcome Measures: Shoulder Range of Motion, Shoulder Range of Motion: Objectively measures shoulder range of motion (in degree) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension., "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, Shoulder Strength: Objectively measures shoulder strength (in newton) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension., "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, Trunk Range of Motion: Objectively measures trunk extension range of motion (in degree)., "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, Trunk Strength: Objectively measures trunk flexion strength (in newton)., "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 Outcome Measures: Weight, Weight (in kilograms) will be measured with InBody, "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"|BMI, BMI (in kg/m²) will be measured with InBody, "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"|Body fat, Body fat (in percentage) will be measured with InBody, "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"|Muscle mass, Muscle mass (in kilograms) will be measured with InBody, "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, DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaires) questionnaires will be administered to asses shoulder pain and disability. Minimum value of 0, maximum value of 100, with higher scores indicating greater dysfunction, "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, Postoperative Satisfaction after Breast reconstruction: BREAST-Q questionnaires will be administered to assess postoperative satisfaction (satisfaction with breast, psychosocial well-being, and sexual well-being). Minimum value of 0 and a maximum value of 100, with higher scores indicating greater satisfaction., "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"