Braest CancerNCT06552650
Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction
A study testing Exercise in people with Braest Cancer and Breast Reconstruction, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Braest Cancer, Breast Reconstruction
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women between the ages of 19 and 70
- Pathologically diagnosed with breast cancer
- Scheduled to undergo unilateral or bilateral mastectomy and breast reconstruction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
Seoul, 03722
Dongwon Lee, MD, Ph.D, 82-2-2228-2215, XYPHOSS@yuhs.ac
About this study
Official title: 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.
- Conditions
- Braest Cancer, Breast Reconstruction
- Being tested
- Exercise, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 CareOther
The full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Not described Receives: Behavioral: Exercise |
| Usual Care Group | Experimental | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: "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).
Measured: "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).
Measured: "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
Weight (in kilograms) will be measured with InBody
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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.
Measured: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start20 Nov 2023
- Primary completion20 Nov 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Braest CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552650
- Sponsor's protocol ID
- 4-2023-1146
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park R, Lee EY, Kang JW, Jun S, Yeon SJ, Jeon JY, Lee DW. Effect of early exercise on functional recovery and surgical outcomes after post-mastectomy breast reconstruction: study protocol for a randomized clinical trial. BMC Cancer. 2026 Apr 25;26(1):731. doi: 10.1186/s12885-026-15949-9.
PubMed 42032503
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Effect of Early Exercise on Functional Restoration of Exercise and Surgical Outcomes After Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06552650
- Acronym / sponsor ID
- 4-2023-1146
- Conditions
- Braest Cancer, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise |
| Usual Care Group | Experimental | Other: Usual Care |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women between the ages of 19 and 70
- Pathologically diagnosed with breast cancer
- Scheduled to undergo unilateral or bilateral mastectomy and breast reconstruction
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseFour 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 | Behavioural | Exercise Group |
| Usual CareThe full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care | Other | Usual Care Group |
Primary outcome
Shoulder Range of Motion
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"
Shoulder Range of Motion: Objectively measures shoulder range of motion (in degree) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension.
Shoulder Strength
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"
Shoulder Strength: Objectively measures shoulder strength (in newton) and measurements include shoulder flexion, abduction, internal rotation, external rotation and extension.
Trunk Range of Motion
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"
Trunk Range of Motion: Objectively measures trunk extension range of motion (in degree).
Trunk Strength
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"
Trunk Strength: Objectively measures trunk flexion strength (in newton).
6 secondary outcomes
Weight
Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
BMI
Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
Body fat
Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
Muscle mass
Time frame: "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
Time frame: "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
Time frame: "1 Day before surgery", "10-14 Days after surgery", "1 Month after surgery", "3 Months after surgery", "6 Months after surgery"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 42032503Park R, Lee EY, Kang JW, Jun S, Yeon SJ, Jeon JY, Lee DW. Effect of early exercise on functional recovery and surgical outcomes after post-mastectomy breast reconstruction: study protocol for a randomized clinical trial. BMC Cancer. 2026 Apr 25;26(1):731. doi: 10.1186/s12885-026-15949-9.
- Individual participant dataSharing planned: No
Related trials for Braest Cancer
RecruitingPhase 2
Dalpiciclib Plus Toremifene for First-line Advanced HR Positive and HER2 Negative Breast Cancer
CANCER, BRAEST CANCER
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Braest Cancer and Breast Reconstruction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Won Lee (82-2228-2215, XYPHOSS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Range of Motion (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"). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06552650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.