What this study is
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.
What's being tested
- Center-Based Walking Exercise
Intervention · BEHAVIORAL
Each exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session.
- Home-Based Walking Exercise
Intervention · BEHAVIORAL
Participants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session.
Study details
- Official title
- Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
- Sponsor
- University of Florida
- Conditions
- Fatigue · Breast Cancer · Cancer, Therapy-Related
- Enrolling
- 24 people
- Starts
- 2023-11-29
- Est. completion
- 2026-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years – 105 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openInstitute on Aging; University of Florida
Gainesville, Florida, United States
- Stephen D Anton, PhD · Contact352-273-7514santon@ufl.edu
- Stephen D Anton, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB202202679
Principal investigator
Stephen Anton
University of Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.