EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer

NCT ID: NCT06115486

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2027-01-31

Brief Summary

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

Detailed Description

This protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast.

As part of the standard exercise program, patients will undergo a fitness evaluation at the AHNCI Exercise Oncology and Resiliency Center before the start of the exercise program. This evaluation will be used to customize the patient exercise program. The exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). The fitness evaluation and exercise program are standard of care. Participation in this study will last the duration of the exercise program, about 3 months. All group exercise sessions will be closely monitored by the center staff who are Certified Strength and Conditioning Specialists (CSCS).

Conditions

Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Arm / ACSM Guidelines

The control group will follow resistance training guidelines from the American College of Sports Medicine (ACSM) with the goal of promoting hypertrophy

Group Type: OTHER

Control Arm ACSM Guidelines

Intervention Type: OTHER

The control group will follow resistance training guidelines from the American College of Sports Medicine. Eight to ten multi-joint exercises will be performed to stress the major muscle groups.

Experimental Arm / EOC Guidelines

The experimental group will use a regimen that is often used by strength and conditioning coaches to maximize hypertrophy, and is part of the standard regimens at the Exercise Oncology Center (EOC)

Group Type: EXPERIMENTAL

Experimental Arm 6-12-25 repetitions per set

Intervention Type: OTHER

The exercise regimens will employ a mixture of compound exercises utilizing both open and closed kinetic chain movements (CKC), focusing on exercises with the goal of increasing skeletal muscle mass and body composition. The regimen will incorporate 6, then 12, then 25 repetitions in sequence per set per muscle group with minimal amounts of rest between.

Interventions

Control Arm ACSM Guidelines

The control group will follow resistance training guidelines from the American College of Sports Medicine. Eight to ten multi-joint exercises will be performed to stress the major muscle groups.

Intervention Type: OTHER

Experimental Arm 6-12-25 repetitions per set

The exercise regimens will employ a mixture of compound exercises utilizing both open and closed kinetic chain movements (CKC), focusing on exercises with the goal of increasing skeletal muscle mass and body composition. The regimen will incorporate 6, then 12, then 25 repetitions in sequence per set per muscle group with minimal amounts of rest between.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Age 20-89 years

• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
• Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.

Exclusion Criteria

• Any current treatment with cytotoxic chemotherapy for breast cancer
• Inability to safely engage in group sessions of resistance training as deemed by study PI
• Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: lead

Responsible Party

Colin Champ, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin Champ, MD, CSCS

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncologist

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Contact

Role: CONTACT

clinicaltrials@ahn.org

4123306151

Facility Contacts

Clinical Trials Contact

Role: primary

clinicaltrials@ahn.org

Other Identifiers

EXERT-BCH

Identifier Type: -

Identifier Source: org_study_id