RecruitingNot ApplicableNCT05684367

Exercise to ReGain Stamina and Energy (The EXERGISE Study)

Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors

Sponsor

University of Florida

Enrollment

24 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Fatigue Cancer, Therapy-Related

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

Sex: FEMALEMin Age: 60 YearsMax Age: 105 Years

Inclusion Criteria7

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 Criteria19

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

Interventions

BEHAVIORALCenter-Based Walking Exercise

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.

BEHAVIORALHome-Based Walking Exercise

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.