Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training.

This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

NCT06113627

Breast Cancer Lymphedema Survivorship Lymphedema of Upper Limb

NOT_YET_RECRUITING NA

Reduction of Lymphedema Secondary to Breast Cancer

NCT04974268

Lymphedema

COMPLETED NA

Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography

NCT06905639

Breast Neoplasms Lymphedema Thermography +1 more

COMPLETED NA

Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study

NCT06459245

Breast Cancer Female

ENROLLING_BY_INVITATION NA

Lymphedema Prevention in Breast Cancer

NCT00760123

BREAST CANCER LYMPHEDEMA

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Physical Activity Lymphedema of Upper Arm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistance training group

Twice a week sessions supervised and group, during 12 weeks

Group Type EXPERIMENTAL

Resistance Training

Intervention Type BEHAVIORAL

The resistance training will be for arms and legs, self-loading type, and external weights.

Control Group

The control group will follow the usual physical therapy management, which does not include resistance training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance Training

The resistance training will be for arms and legs, self-loading type, and external weights.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed with stage I-III breast cancer, histologically confirmed.
* Patients scheduled to receive adjuvant post-operative chemotherapy.
* Partial or total mastectomy with axillary node dissection.
* Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m2.
* Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program.

Exclusion Criteria

* Inter-limb volume difference greater than 200 ml or 10%.
* Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy).
* Breast cancer stage IV
* Unable to participate in an exercise program related to other medical problems.
* Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations.
* Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m2.
* Pregnancy.
* Fluency and understanding of the Spanish language.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No