Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning

NCT07023887 | Recruiting

• 1 other identifier: 2025-076-SG
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the impact of four standard of care, monitored group exercise regimens (resistance training) on conditioning and hypertrophy in women previously treated for breast cancer. The study will compare two conditioning regimens (6-12-25 and 8x8) and two hypertrophy regimens (5/5/5 cluster sets and double training) to assess changes in VO2 max, muscle mass, and fat mass.

Conditions

Cancer; Breast Cancer

Keywords

exercise

Outcome Measures

Primary Outcomes (3)

• Change in VO2 max

  Change in maximal oxygen consumption (VO2 max) measured during and after each exercise regimen.

  Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.

• Change in Muscle and Fat Mass

  Change in muscle mass and fat mass in pounds as measured by InBody 970.

  Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

• Change in Muscle and Fat Mass

  Change in muscle mass and fat mass in pounds as measured by ultrasound.

  Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

Secondary Outcomes (2)

• Change in Hand Grip Strength

  Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

• Change in Psychology Questionnaire Scores

  Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

Interventions

6-12-25 Training Regimen OTHER

A conditioning regimen involving three exercises performed consecutively with minimal rest. Includes 4-6 repetitions at 4-0-1-0 tempo, 10-12 repetitions at 3-0-1-0 tempo, and 20-25 repetitions at 2-0-1-0 tempo.

8x8 Training Regimen OTHER

A conditioning regimen optimizing high volume with short rest periods. Six exercises are performed consecutively with a 2-0-1-0 tempo and no rest between sets.

5/5/5 Cluster Set Training Regimen OTHER

A hypertrophy regimen where an individual performs 5 repetitions at a tempo of 4 seconds during the eccentric movement of the exercise, while performing the concentric motion in 1 second then resting for 20 seconds and repeating the sequence two additional times to total three clusters of 5 repetitions.

Double Training Regimen OTHER

A hypertrophy regimen adding an additional set of lesser repetitions for a specified exercise at the end of a tri-set of exercises.

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited via convenience sampling from the Study Investigators' practice patient population, referrals from other physicians' practices, or identifiable medical record review (e.g., EPIC).

You may qualify if:

• Age 20-89 years
• Women prescribed exercise as a Standard of Care
• Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) 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.
• Women with \> 6 months of resistance training experience under expert guidance by a CSCS

You may not qualify if:

• Any current treatment with cytotoxic chemotherapy for breast cancer
• Inability to safely engage in group sessions of resistance training as deemed by study Pl
• Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by Pl to be unsafe to engage in resistance training
• Beta blocker or GLP-1 inhibitor medications
• Pregnant women
• Males

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Colin Champ

  AHN Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

412-330-6151; ctgov@ahn.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 17, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)