Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction

NCT ID: NCT06552650

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Braest Cancer Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Group

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Usual Care Group

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

The full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care

Interventions

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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

Intervention Type BEHAVIORAL

Usual Care

The full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Won Lee

Role: CONTACT

82-2228-2215

Facility Contacts

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Dongwon Lee, MD, Ph.D

Role: primary

82-2-2228-2215

Other Identifiers

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4-2023-1146

Identifier Type: -

Identifier Source: org_study_id

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