Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction

NCT06552650 | Recruiting

• 1 other identifier: 4-2023-1146
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Braest Cancer; Breast Reconstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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"

• Body fat

  "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"

• 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"

Study Arms (2)

Exercise Group

EXPERIMENTAL

Behavioral: Exercise

Usual Care Group

EXPERIMENTAL

Other: Usual Care

Interventions

Exercise 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

Exercise Group

Usual Care OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dong Won Lee

CONTACT

82-2228-2215; XYPHOSS@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: August 14, 2024
• Study Start: November 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: June 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)