EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA

Recruiting

• Conditions: Breast Cancer Female
• Interventions: Other: Observation of Exercise Program Adherence

• Registration Number: NCT05747209
• Lead Sponsor: Colin Champ, MD

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.

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 Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-02
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-25
• Last Update Submitted: 2023-02-25
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-05
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard High-load resistance training	Observation of Exercise Program Adherence	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States