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The EXERGISE Study: Walking Exercise for Fatigue in Older Breast Cancer Survivors

This study, called The EXERGISE Study, is looking at how different types of walking exercise can help reduce fatigue (extreme tiredness) in older women who have had breast cancer. Many breast cancer survivors experience fatigue after treatment, especially older women. This study will test two types of walking programs: Center-Based Walking Exercise, which involves supervised walking sessions, and Home-Based Walking Exercise, where you walk in your community. The main goal is to see if these exercises can improve your self-reported fatigue over 8 weeks. You may be able to join if you are a woman aged 60 to 105, had stage I-III breast cancer diagnosed in 2021 or 2022, completed your main cancer treatment at least 3 months but no more than 1 year ago, and have at least moderate fatigue. The current status of this study is unclear.

Study design
This is a pilot randomized clinical trial involving 24 female participants. Participants will be randomly assigned to either a center-based or home-based walking exercise intervention.
What's involved
Participants will engage in walking exercise sessions for 8 weeks. For Center-Based, this involves a warm-up and 30 minutes of walking per session. For Home-Based, it involves walking five days/week, starting with 10-15 minutes and gradually increasing duration.
Compensation
Not stated in the trial record.
Follow-up
Self-reported fatigue will be measured at baseline and up to Week 8, indicating the study's focus during this period.

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NCT05684367

Exercise to ReGain Stamina and Energy (The EXERGISE Study)

Recruiting
NAAges 60+InterventionalTreatment
University of Florida
~24 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Center-Based Walking ExerciseHome-Based Walking Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-Reported Fatigue
Measured over Baseline up to Week 8

Conditions

Fatigue
Breast Cancer
Cancer, Therapy-Related

Explore related trials

Breast CarcinomaFatigue

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Stephen Anton · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Stephen D Anton, PhD
[email protected]
352-273-7514
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Consent to participate in the study
Age ≥ 60 years old
Had stage I-III invasive breast cancer
The cancer is diagnosed in 2021 or 2022
Completed adjuvant therapy for at least 3 months but no more than 1 year
Willingness to participate in all study procedures
Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)

Exclusion

Failure to provide informed consent
Current involvement in rehabilitation program
Absolute contraindications to exercise training
Significant cognitive impairment
Progressive, degenerative neurologic disease
Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
Other significant comorbidities that may impair ability to participate in the exercise intervention
Pregnant
Regular consumption of nicotinamide riboside supplement
Simultaneous participation in other interventional studies
Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System
Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
Receipt of any probiotics within 4 weeks of screening
History of active treatment for HIV, hepatitis B, or hepatitis C infection
Positive stool cultures for enteric pathogens, including Clostridium difficile
Excessive alcohol use (i.e., \> 14 drinks/week) or alcohol abuse (i.e., \> 5 drinks/day for males or \> 4 drinks/day for females)
Other substance abuse within the past 3 years
Smoking history in past 3 years

What this trial measures

  • Self-Reported FatigueBaseline up to Week 8

    Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.