Exercise to ReGain Stamina and Energy (The EXERGISE Study)

NCT ID: NCT05684367

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2026-08-31

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.

Detailed Description

Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.

In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.

Conditions

Fatigue; Breast Cancer; Cancer, Therapy-Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Center-Based Walking Exercise

Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.

Group Type: EXPERIMENTAL

Center-Based Walking Exercise

Intervention Type: 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

Subjects will be randomly assigned to walk for exercise in their community five days/week.

Group Type: EXPERIMENTAL

Home-Based Walking Exercise

Intervention Type: 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.

Interventions

Center-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.

Intervention Type: BEHAVIORAL

Home-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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Anton

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Institute on Aging; University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Stephen D Anton, PhD

Role: primary

santon@ufl.edu

352-273-7514

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Other Identifiers

OCR42286

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202102537

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202202679

Identifier Type: -

Identifier Source: org_study_id