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The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:
Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.
Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations.
This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate.
The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard High-load resistance training | Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of Exercise Program Adherence | Other | Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. |
| Measure | Description | Time Frame |
|---|---|---|
| Session Attendance | Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%. | Baseline and Three (3) months |
| Change in Adipose Tissue (InBody, kg) | Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR). | Baseline and Three (3) months |
| Change in Adipose Tissue (Ultrasound, Lbs) | Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR). | Baseline and Three (3) months |
| Change in Muscle Mass | Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months. | Baseline and Three (3) months |
| Change in Fat-Free Mass | Changes in percent fat-free mass (measured by ultrasound) from baseline to three months. | Baseline and Three (3) months |
| Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Will Undergo an Assessment 1 Year Following the Exercise Program. | Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Females aged 20-89 years with newly diagnosed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast who have undergone and completed treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Colin Champ, MD | AGH Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38491821 | Derived | Carpenter DJ, Peluso C, Hilton C, Velasquez F, Annichine A, Matsko K, Rosenberg J, Diaz AK, Hyde P, Beriwal S, Champ CE. EXERT-BC: A pilot study of an exercise regimen designed to improve functional mobility, body composition, and strength after the treatment for breast cancer. Cancer Med. 2024 Mar;13(5):e7001. doi: 10.1002/cam4.7001. |
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There were 54 total patients screened for eligibility (Fig. 2).
There were 9 patients who chose not to participate due to scheduling conflicts
There were 2 patients screened who were referred to PT due to joint & musculoskeletal conditions precluding safe training
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard High-load Resistance Training | Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. Observation of Exercise Program Adherence: Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard High-load Resistance Training | Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. Observation of Exercise Program Adherence: Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Session Attendance | Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%. | Participants who completed at least 75% of the planned exercise sessions. | Posted | Count of Participants | Participants | Baseline and Three (3) months |
|
3 months per patient
AEs/SAEs meet the ct.gov definitions: accidental disclosure of confidentiality and injury from exercise program All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard High-load Resistance Training | Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. Observation of Exercise Program Adherence: Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Champ, MD | Allegheny General Hospital | 412-734-7605 | colin.champ@ahn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2023 | Apr 24, 2024 | Prot_SAP_000.pdf |
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|
| Baseline and Three (3) months |
| Activity Levels Via Godin Questionnaire | Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary | 3 months |
| Resting Metabolic Rate as Calories Burned Per Day | Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis. | Baseline and Three (3) months |
| Functional Movement Screen | A functional movement screen will be performed pre and post regimen to assess change in overall score Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of "if any pain felt by the subject during the movement", "subject is unable to perform the movement", "subject performs the movement through compensatory movements", and "subject performs the movement correctly", respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome. | Baseline and Three (3) months |
| Y-balance Score | A Y-balance test will be performed pre and post regimen to assess change Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk. | Baseline and Three (3) months |
| Changes in Strength From Baseline Through Study Completion, up to 3 Months | Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3. | Baseline and months 1, 2, and 3 |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Change in Adipose Tissue (InBody, kg) | Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR). | Participants whose change in adipose tissue was measured. | Posted | Median | Inter-Quartile Range | kg | Baseline and Three (3) months |
|
|
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| Primary | Change in Adipose Tissue (Ultrasound, Lbs) | Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR). | Posted | Median | Inter-Quartile Range | percentage of Body Fat | Baseline and Three (3) months |
|
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| Primary | Change in Muscle Mass | Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months. | Posted | Median | Inter-Quartile Range | kg | Baseline and Three (3) months |
|
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| Primary | Change in Fat-Free Mass | Changes in percent fat-free mass (measured by ultrasound) from baseline to three months. | Posted | Median | Inter-Quartile Range | kg | Baseline and Three (3) months |
|
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| Primary | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Three (3) months |
|
|
|
| Primary | Activity Levels Via Godin Questionnaire | Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
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| Primary | Resting Metabolic Rate as Calories Burned Per Day | Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis. | Posted | Median | Inter-Quartile Range | kcal | Baseline and Three (3) months |
|
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| Primary | Functional Movement Screen | A functional movement screen will be performed pre and post regimen to assess change in overall score Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of "if any pain felt by the subject during the movement", "subject is unable to perform the movement", "subject performs the movement through compensatory movements", and "subject performs the movement correctly", respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Three (3) months |
|
|
|
| Primary | Y-balance Score | A Y-balance test will be performed pre and post regimen to assess change Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk. | Posted | Median | Inter-Quartile Range | ratio | Baseline and Three (3) months |
|
|
|
| Primary | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3. | Posted | Median | Inter-Quartile Range | Load (kilograms x Repetitions x Sets) | Baseline and months 1, 2, and 3 |
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| Secondary | Participants Will Undergo an Assessment 1 Year Following the Exercise Program. | Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility | Not Posted | 12 months | Participants |
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
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| EuroQol 5 Dimension 2 Self-Care Score Post-Intervention |
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| EuroQol 5 Dimension 3 Usual Activities Score Baseline |
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| EuroQol 5 Dimension 3 Usual Activities Score Post-Intervention |
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| EuroQol 5 Dimension 4 Pain / Discomfort Score Baseline |
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| EuroQol 5 Dimension 4 Pain / Discomfort Score Post-Intervention |
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| EuroQol 5 Dimension 5 Anxiety / Depression Score Baseline |
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| EuroQol 5 Dimension 5 Anxiety / Depression Score Post-Intervention |
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| EuroQol 5 Dimension 6 Current Overall Health-Related Quality of Life Score Baseline |
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| EuroQol 5 Dimension 6 Current Overall Health-Related Quality of Life Score Post-Intervention |
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| US RMR Post-intervention |
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| Title | Measurements |
|---|---|
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| Post-intervention Right Side |
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| Load Trap Bar Deadlift, Month 1 (Week 4) |
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| Load Trap Bar Deadlift, Month 2 (Week 4) |
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| Load Trap Bar Deadlift, Month 3 (Week 4) |
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| Incline Dumbbell Bench, Month 1 (Week 4) |
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| Incline Dumbbell Bench, Month 2 (Week 4) |
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| Incline Dumbbell Bench, Month 3 (Week 4) |
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| Bird Dog Row, Month 1 (Week 4) |
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| Bird Dog Row, Month 2 (Week 4) |
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| Bird Dog Row, Month 3 (Week 4) |
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