NCT07739563

Brief Summary

In this study, the investigators hypothesize that observed intense resistance training with conditioning elicits similar changes in body composition, muscle mass, and blood pressure as that with cardiovascular training (or cardio) for women treated with breast cancer.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
11mo left

Started Jul 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Jul 2027

Study Start

First participant enrolled

July 1, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

  • Change in Muscle Mass

    Measured as total muscle mass (kg), determined via InBody 970 bioimpedance analysis and ultrasound (BodyMetrix) for muscle tissue thickness.

    Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).

  • Change in Fat Mass

    Measured as total fat mass (kg), determined via InBody 970 bioimpedance analysis and ultrasound (BodyMetrix) for adipose tissue thickness.

    Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).

Secondary Outcomes (6)

  • Change in Blood Pressure

    Baseline (Prior to Program), at Month 1, and At Exercise Program Completion (approximately 2 months).

  • Change in Resting Metabolic Rate

    At Exercise Program Completion (approximately 2 months).

  • Change in Body Composition Metrics (Other than Muscle/Fat Mass)

    Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).

  • Change in Phase Angle

    Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).

  • Exercise Adherence

    Throughout the Exercise Program (approximately 2 months).

  • +1 more secondary outcomes

Study Arms (2)

Cardio Training

EXPERIMENTAL
Behavioral: Resistance Training with Cardio

Conditioning Training

EXPERIMENTAL
Behavioral: Resistance Training with Conditioning

Interventions

Participants in this arm will engage in a supervised exercise regimen three times per week, for approximately 2 months (8 weeks). The regimen combines two days of hypertrophy-focused resistance training with a third day dedicated to steady-state cardiovascular exercise. The cardio day will utilize ergometer-based exercises (rowing ergometer, Assault Air Bike) and unweighted sled pushes, with each activity lasting 10 minutes continuously. The overall program aims to improve cardiorespiratory fitness and body composition in breast cancer survivors, under the guidance of Certified Strength and Conditioning Specialists (CSCS).

Cardio Training

Participants in this arm will engage in a supervised exercise regimen three times per week, for approximately 2 months (8 weeks). The regimen combines two days of hypertrophy-focused resistance training with a third day dedicated to high-intensity conditioning. The conditioning day involves a circuit format of 6 total exercises, completed for 8 repetitions each across 8 sets, with limited rest periods (10 seconds or less) between exercises and sets. Exercise selection is total-body focused, alternating between upper and lower body movements. The program aims to improve muscular conditioning and body composition in breast cancer survivors, under the guidance of Certified Strength and Conditioning Specialists (CSCS).

Conditioning Training

Eligibility Criteria

Age20 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-89 years
  • Women prescribed exercise as a SOC
  • 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 \> 3 months of resistance training experience under expert guidance by a CSCS
  • Must be able to read and understand English and consent for themselves.

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 PI
  • Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
  • Beta blocker or GLP-1 inhibitor medications
  • Pregnant women
  • Males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Colin Champ, MD, CSCS

    AHN Radiation Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations