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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Female

• Registration Number: NCT06115486
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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).

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Study Start: 2024-01-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine changes in muscle and fat mass during and after each exercise regimen	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 Outcome Measures

Name	Time	Method
Determine changes in strength measured via load calculations (repetitions x sets x weight)	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.
Determine adherence defined as number of sessions attended of total sessions	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.

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States