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NCT Number: NCT07023887

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

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.

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Key information

Conditions

Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–89 year

Sex eligibility

Female

Study type

Observational

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location status: Recruiting

Location contact

Clinical Trials Contact

CONTACT

[email protected]

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 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

Treatment and study plan

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.

Primary outcomes

  1. Change in VO2 max

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

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

  2. 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 mass and fat mass in pounds as measured by InBody 970.

  3. 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 mass and fat mass in pounds as measured by ultrasound.

Secondary outcomes

  1. 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.

    Measurement of hand grip strength using a dynamometer to assess upper body strength and function.

  2. 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.

    Assessment of psychological well-being, including confidence, motivation (intrinsic & extrinsic), anxiety, and depression, using a Psychological Screen for Strength Training questionnaire. The responses to the variables will be calculated. The rating scale will be calculated 0-3. Not at all (0), some of the time (1), most of the time (2), and all the time (3).

Study contacts

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

Clinical Trials Contact

CONTACT

[email protected]

412-330-6151

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: EXERT-BCHC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
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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