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Home-Based Exercise for Breast Cancer (EMBRACE Trial)
N/A
Waitlist Available
Led By Laura Rogers, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks after baseline
Awards & highlights
EMBRACE Trial Summary
This trial will test whether a home-based exercise program can improve the health of cancer survivors by enhancing treatments targeting the gut microbiome.
Who is the study for?
This trial is for non-Hispanic white or black women aged 18-70 who have had breast cancer stages 0, I, II, or III and are at least one year post-treatment. Participants must speak English, be able to walk without help, not use antibiotics or probiotics recently, and have internet access with videoconferencing capability.Check my eligibility
What is being tested?
The study tests a home-based exercise program's impact on the gut microbiome of breast cancer survivors. It aims to see if this remote protocol works well for those who can't attend supervised sessions and if results vary by race.See study design
What are the potential side effects?
Since the intervention involves moderate aerobic exercise at home, potential side effects might include typical exercise-related issues such as muscle soreness or strain. However, specific risks will depend on individual health conditions.
EMBRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility - Adherence to study protocol activities
Feasibility - Adverse events
Feasibility - Attrition rates
+2 moreSecondary outcome measures
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
+8 moreEMBRACE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based aerobic exercise trainingExperimental Treatment1 Intervention
home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness.
Group II: Home-based standard attention flexibility/toning controlActive Control1 Intervention
Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based exercise intervention
2015
Completed Phase 4
~460
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,981 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Laura Rogers, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not taken any antibiotics in the last 90 days.You can walk without needing help.You are unable to do moderate or intense aerobic exercise.You have a lung disease called interstitial lung disease.You have schizophrenia or are currently experiencing severe mental confusion or hallucinations.You have been exercising for more than 30 minutes, at least 3 days a week, in the past six months.You had weight loss surgery in the past.You have cancer that has spread to other parts of your body or has come back after treatment.You have been diagnosed with another type of cancer within the last 5 years, except for early stage skin or cervical cancer.You have unstable chest pain.You have dementia or a brain disorder.You have a connective tissue or rheumatologic disease.Your asthma is not well controlled.You weigh more than 440 pounds.Women who are not of white or black ethnicity.You must be between 18 and 70 years old.You have had early stage breast cancer in the past.You finished your main cancer treatment at least 1 year ago.You are currently taking steroids.You are not able to do moderate intensity aerobic exercise because of physical limitations.You have a safe place to do aerobic exercise, such as walking in your neighborhood or owning exercise equipment at home.You have moderate to severe congestive heart failure according to the New York Heart Association classification.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the targeted results of this research?
"The main objective of this 10-week study is to gauge the attrition rate. Secondary outcomes include analysis of muscle mass using Tanita's bioelectrical impedance analysis scale (with higher readings being more beneficial), evaluation of body mass index (higher numbers are worse) and measurement of body fat percentage (lower scores are better)."
Answered by AI
Are there any unfilled roles available to participate in the experiment?
"Indeed, the records on clinicaltrials.gov show that this medical experiment is actively enrolling subjects; it was initially published on September 1st 2021 and most recently updated November 9th 2022. Presently, there are 40 vacancies at a single research centre."
Answered by AI
Are aged participants accepted in this clinical trial?
"The parameters of eligibility for the trial stipulate that candidates must be between 18 and 70 years old. There are 65 trials available to those below the age of majority, while adults over 65 can access 2,217 studies."
Answered by AI
To which patient demographic is this clinical trial open?
"Admission for this trial requires a diagnosis of breast cancer and an age between 18 to 70 years old. Forty people will be selected in total."
Answered by AI
What is the ceiling for recruitment in this trial?
"Yes, evidence on clinicaltrials.gov seems to suggest that recruitment is still ongoing for this trial which was first listed back in September of 2021. Updates were made as recently as November 9th 2022 and 40 patients are needed at one site location."
Answered by AI
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