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Recruiting NCT07023887

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

— Observational Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 6-12-25 Training Regimen, 8x8 Training Regimen, 5/5/5 Cluster Set Training Regimen, Double Training Regimen.
Who it may be relevant to
Registry conditions: Cancer, Breast Cancer. Basic parameters: 20 years — 89 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

EXERT-BCHC: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning

Overview

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.

Interventions

  • Other 6-12-25 Training Regimen
    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.
  • Other 8x8 Training Regimen
    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.
  • Other 5/5/5 Cluster Set Training Regimen
    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.
  • Other Double Training Regimen
    A hypertrophy regimen adding an additional set of lesser repetitions for a specified exercise at the end of a tri-set of exercises.

Primary outcome measures

  • Change in VO2 max [Time frame: Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.]
  • Change in Muscle and Fat Mass [Time frame: 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 [Time frame: 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 outcome measures (2)
  • Change in Hand Grip Strength [Time frame: 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 [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • 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

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Allegheny General Hospital — Pittsburgh

Identifiers

NCT: NCT07023887 · 2025-076-SG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗