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Trial Title:
EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA
NCT ID:
NCT05747209
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Observation of Exercise Program Adherence
Description:
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.
Arm group label:
Standard High-load resistance training
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samantha Campbell
Phone:
412-330-6151
Email:
samantha.campbell@ahn.org
Start date:
October 1, 2022
Completion date:
August 2023
Lead sponsor:
Agency:
Colin Champ, MD
Agency class:
Other
Source:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747209
