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RecruitingNCT06552650Updated Aug 14, 2024

Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction

An interventional study of Exercise and Usual Care in Braest Cancer and Breast Reconstruction, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2024).
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Braest Cancer
  • Breast Reconstruction
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Exercise Group

    Behavioral: Exercise

  • Experimental
    Usual Care Group

    Other: Usual Care

Interventions

  • BehavioralExercise

    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

  • OtherUsual Care

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: "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"

  2. Shoulder Strength

    Shoulder Strength: Objectively measures shoulder strength (in newton) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension.

    Time frame: "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"

  3. Trunk Range of Motion

    Trunk Range of Motion: Objectively measures trunk extension range of motion (in degree).

    Time frame: "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"

  4. Trunk Strength

    Trunk Strength: Objectively measures trunk flexion strength (in newton).

    Time frame: "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

  1. Weight

    Weight (in kilograms) will be measured with InBody

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

  2. BMI

    BMI (in kg/m²) will be measured with InBody

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

  3. Body fat

    Body fat (in percentage) will be measured with InBody

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

  4. Muscle mass

    Muscle mass (in kilograms) will be measured with InBody

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

  5. 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

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

  6. 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.

    Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"

07

Study locations

1 of 1 sites recruiting
  • Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
    Seoul, 03722, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06552650
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Aug 14, 2024
Start date
Nov 20, 2023
Primary completion
Nov 20, 2023
Completion
Jun 30, 2025 (estimated)
Last update
Aug 14, 2024

Study contacts

Dong Won Lee
Contact
XYPHOSS@yuhs.ac
82-2228-2215

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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