Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction; Braest Cancer
• Intervention / Treatment: Behavioral: Exercise; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Won Lee; Phone Number: 82-2228-2215; Email: XYPHOSS@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
    • Contact: Dongwon Lee, MD, Ph.D; Phone Number: 82-2-2228-2215; Email: XYPHOSS@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group	Behavioral: Exercise; Four supervised exercise interventions after surgery: One exercise education session per week from postoperative day 5 through 1 month Subsequent home-based exercise: Home-based exercise recommendations from 1 month to 3 months post-surgery
Experimental: Usual Care Group	Other: Usual Care; The full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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"

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): November 20, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 4-2023-1146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No