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

Breast Cancer Female Clinical Trial

— EXERT-BC  

Official title:

Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747209
• Other study ID #: EXERT-BC
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Samantha Campbell
• Phone: (412) 330-6151
• Email: samantha.campbell[@]ahn.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Colin Champ, MD

Country where clinical trial is conducted

United States, 

Outcome

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