Walking exercise to reduce fatigue in older breast cancer survivors
Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
This study is testing whether two types of walking exercises can help older women who have survived breast cancer feel less tired.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 60 Years to 105 Years |
| Sex | Female |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05684367 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the effectiveness of two types of walking exercise interventions—center-based and home-based—on reducing fatigue in older women who have survived invasive breast cancer. The study will enroll 24 female participants aged 60 and older who have completed their cancer treatment within the last year and are experiencing moderate to severe fatigue. Participants will be randomly assigned to one of the two exercise groups for an 8-week period, allowing researchers to gather preliminary data and refine methodologies for a potential larger study. The focus is on understanding how aerobic exercise can alleviate fatigue, particularly in older survivors who may not respond as well to traditional interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 60 and older who have completed adjuvant therapy for invasive breast cancer within the past year and are experiencing moderate to severe fatigue.
Not a fit: Patients who are currently involved in rehabilitation programs or have significant comorbidities that impair their ability to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored exercise approach to significantly reduce fatigue in older breast cancer survivors, improving their quality of life.
How similar studies have performed: Previous studies have shown that aerobic exercise can improve fatigue in younger breast cancer survivors, but this approach specifically targeting older survivors is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- Institute on Aging; University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Anton — University of Florida
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.