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NCT03760536 · ClinicalTrials.gov registry record
Get REAL and HEEL Research Program
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 35
- Enrollment target
NCT03760536: Completed study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03760536 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03760536 has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
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.
Primary Outcome
The Cardiopulmonary Exercise Test (CPET) with NIRS and PWA will be used to measure peak oxygen content (VO2peak), tissue oxygen saturation and pulse wave analysis during this symptom-limited exercise test.
Interventions
- BEHAVIORAL 16-week Exercise Rehabilitation Program for Breast Cancer Survivors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2020-02-12 |
What the finished NCT03760536 record still lists
NCT03760536 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which 16-week Exercise Rehabilitation Program for Breast Cancer Survivors is the first listed.
NCT03760536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03760536 about?
NCT03760536 is a clinical study titled "Get REAL and HEEL Research Program". 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 prog...
What is the current status of trial NCT03760536?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2017-03-20. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT03760536?
The interventions under investigation include: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors (BEHAVIORAL).
Who is sponsoring clinical trial NCT03760536?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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