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

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT06115486

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Carcinoma in Situ Breast Cancer Female	Other: Control Arm ACSM Guidelines Other: Experimental Arm 6-12-25 repetitions per set	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will include rolling block randomization of two groups of 15 participants in each group. The 6-12-25 arm will be enrolled first, followed by the ACSM arm.The study will include rolling block randomization of two groups of 15 participants in each group. The 6-12-25 arm will be enrolled first, followed by the ACSM arm.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: 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.
Experimental: 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)	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.

Arm

Intervention/Treatment

Other: 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

Other: 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.

Experimental: 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)

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Colin Champ, MD, CSCS, Radiation Oncologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colin Champ, MD, Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

ClinicalTrials.gov Identifier:

NCT06115486

Other Study ID Numbers:

EXERT-BCH

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 8, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Colin Champ, MD, Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Additional relevant MeSH terms:

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Study Results

No Results Posted as of Nov 8, 2023