CancerEXERT-BCHCNCT07023887
Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
An observational study of Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 89 years, women only
- Conditions the study is for
- Cancer, Breast Cancer
- What is being tested?
- 6-12-25 Training Regimen, 8x8 Training Regimen and 5/5/5 Cluster Set Training Regimen
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 3 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, 4123306151, ctgov@ahn.org
About this study
Official title: EXERT-BCHC: 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.
- Conditions
- Cancer, Breast Cancer
- Being tested
- 6-12-25 Training Regimen, 8x8 Training Regimen, 5/5/5 Cluster Set Training Regimen, Double Training Regimen
- Keywords
- exercise
- Medical subject headings
- Neoplasms, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-12-25 Training RegimenOther
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 RegimenOther
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 RegimenOther
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 RegimenOther
A hypertrophy regimen adding an additional set of lesser repetitions for a specified exercise at the end of a tri-set of exercises.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 max
Change in maximal oxygen consumption (VO2 max) measured during and after each exercise regimen.
Measured: 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.
Measured: 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.
Measured: 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
Measurement of hand grip strength using a dynamometer to assess upper body strength and function.
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start21 May 2025
- Primary completion3 May 2027 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Colin Champ, Principal investigator, AHN Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023887
- Sponsor's protocol ID
- 2025-076-SG
- Acronym
- EXERT-BCHC
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request the investigators plan to share unidentified data
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXERT-BCHC: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
- ClinicalTrials.gov ID
- NCT07023887
- Acronym / sponsor ID
- EXERT-BCHC / 2025-076-SG
- Conditions
- Cancer, Breast Cancer
- Keywords
- exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-12-25 Training RegimenA 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 RegimenA 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 RegimenA 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 RegimenA hypertrophy regimen adding an additional set of lesser repetitions for a specified exercise at the end of a tri-set of exercises. | Other | – |
Primary outcome
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.
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. Upon reasonable request the investigators plan to share unidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Champ principal investigator
AHN Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Contact (412-330-6151, ctgov@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 max (time frame: Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.