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Get REAL and HEEL Research Program

NCT03760536 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2021-09-02

No results posted yet for this study

Summary

The UNC Get REAL \& HEEL (GR\&H) program has provided after treatment support for women with a breast cancer diagnosis since 2006. The 16-week program includes an individualized training program and the opportunity to continue working out in the GR\&H facilities at the conclusion of the 16-week program. The purpose of this protocol is to implement a research agenda at GR\&H that will examine the efficacy of the program. The primary aim of this study is a pre-post test of the impact of the GR\&H program (standardized combination of aerobic and resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality of life as well as cardiorespiratory function (vascular health), physical function (muscular strength, body composition), cognition, balance, and patient-reported outcomes (fatigue, depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3) circulating pro- and anti-inflammatory cytokines.

Conditions

Interventions

BEHAVIORAL

16-week Exercise Rehabilitation Program for Breast Cancer Survivors

Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Claudio L Battaglini, PhD · UNC Lineberger Comprehensive Cancer Center

  • Kirsten Nyrop · UNC Lineberger Comprehensive Cancer Center

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2019-03-09
Completion
2020-02-12

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760536 on ClinicalTrials.gov