NCT05684367 Exercise to ReGain Stamina and Energy (The EXERGISE Study)
| NCT ID | NCT05684367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-11-29 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-11-29 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Stephen Anton
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05684367 clinical trial?
This trial is open to female participants only, aged 60 Years or older, up to 105 Years, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05684367 currently recruiting?
Yes, NCT05684367 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Florida to inquire about joining.
Where is the NCT05684367 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05684367 clinical trial?
NCT05684367 is sponsored by University of Florida. The principal investigator is Stephen Anton at University of Florida. The trial plans to enroll 24 participants.