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NCT Number: NCT06115486

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

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.

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Key information

Age range

20 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location status: Recruiting

Location contact

Clinical Trials Contact

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Arm ACSM Guidelines

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 6-12-25 repetitions per set

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.

Primary outcomes

  1. Determine changes in muscle and fat mass during and after each exercise regimen

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

Secondary outcomes

  1. Determine adherence defined as number of sessions attended of total sessions

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

  2. Determine changes in strength measured via load calculations (repetitions x sets x weight)

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Contact

CONTACT

[email protected]

4123306151

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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