EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA (EXERT-BC)

• ClinicalTrials.gov Identifier: NCT05747209
• Recruitment Status: Recruiting
• First Posted: February 28, 2023
• Last Update Posted: February 28, 2023
• Sponsor: Colin Champ, MD
• Information provided by (Responsible Party): Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study Description

Brief Summary:

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:

• Is resistance training feasible following breast cancer treatment
• Can it improve the body's mobility and strength lost as a result of the breast cancer treatment
• can it improve the body's composition (for example muscle mass)
• can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.

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.

Condition or disease	Intervention/treatment
Breast Cancer Female	Other: Observation of Exercise Program Adherence

Detailed Description:

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Other
• Target Follow-Up Duration: 3 Months
• Official Title: Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer
• Actual Study Start Date: October 1, 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: August 2023

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Session Attendance [ Time Frame: Three (3) months ]
   Calculated as the proportion 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%.
2. Adipose Tissue in pounds [ Time Frame: 3 months ]
   Change in adipose tissue (lbs) pre and post resistance training regimen measured via ultrasound
3. Adipose Tissue in pounds [ Time Frame: 3 months ]
   Change in adipose tissue (lbs) pre and post resistance training regimen measured via bioimpedance analysis
4. Muscle Mass in pounds [ Time Frame: 3 months ]
   Change in muscle mass (lbs) pre and post resistance training regimen measured via bioimpedance analysis
5. Muscle Mass in pounds [ Time Frame: 3 months ]
   Change in muscle mass (lbs) pre and post resistance training regimen measured via ultrasound
6. Quality of Life via the EuroQol Group survey EQ5D [ Time Frame: 3 months ]
   Change in quality of life measured by EQ5D test pre and post regimen
7. Activity Levels via Godin Questionnaire [ Time Frame: 3 months ]
   Change in activity levels measured by Godin Questionnaire pre and post regimen
8. Resting Metabolic Rate as calories burned per day [ Time Frame: 3 months ]
   Change in resting metabolic rate pre and post regimen measured via bioimpedance analysis
9. Resting Metabolic Rate as calories burned per day [ Time Frame: 3 months ]
   Change in resting metabolic rate pre and post regimen measured via ultrasound
10. Functional Movement Screen [ Time Frame: 3 months ]
    A functional movement screen will be performed pre and post regimen to assess change
11. Balance [ Time Frame: 3 months ]
    A Y-balance test will be performed pre and post regimen to assess change
12. Strength [ Time Frame: 3 months ]
    Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

1. Age 20-89 years
2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
4. Participants must have abstained from smoking for at least 12 months
5. Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
6. Participants must be determined capable of engaging in resistance training.
7. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
8. Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel.
9. Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI
10. Participants must be able to get down and up from the ground and squat their body weight.

Exclusion Criteria:

1. Any treatment with chemotherapy for breast cancer
2. Inability to get and down off the ground or squat body weight
3. Inability to safely engage in group sessions
4. Severe arthritic, joint, cardiovascular, or musculoskeletal condition

Contacts and Locations

Contacts

Contact: Samantha Campbell; (412) 330-6151; samantha.campbell@ahn.org

Locations

United States, Pennsylvania

Allegheny General Hospital; Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contact: Samantha Campbell 412-330-6151 samantha.campbell@ahn.org

Sponsors and Collaborators

Colin Champ, MD

Investigators

• Principal Investigator: Colin Champ, MD; AGH Radiation Oncology

More Information

• Responsible Party: Colin Champ, MD, Director of the AHN CI Exercise Oncology and Resiliency Center, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• ClinicalTrials.gov Identifier: NCT05747209
• Other Study ID Numbers: EXERT-BC
• First Posted: February 28, 2023
• Last Update Posted: February 28, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases