Actively Recruiting

Phase Not Applicable
Age: 60Years - 105Years
FEMALE
ID05684367

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

Led by University of Florida · Updated on 2026-02-05

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Older breast cancer survivors often experience significant fatigue after cancer treatment, with this study focusing on women aged 60 and above who completed therapy for invasive breast cancer within the past year. The research aims to evaluate two types of walking exercise programs to see if they can reduce fatigue levels in this group, as fatigue tends to be more severe with increasing age. This pilot randomized trial will help gather preliminary data and improve study methods for future larger trials. Participants will be randomly assigned to one of two walking exercise programs for eight weeks. One group will do center-based walking sessions three times a week, including warm-up, 30 minutes of moderate-intensity walking, and encouraged periods of vigorous walking. The other group will follow a home-based walking plan, starting with 10-15 minutes per session and increasing by five minutes weekly, aiming for 30 minutes per session, five days a week. Throughout the study, participants will report their fatigue levels and other measures such as mental distress, pain, sleep disturbance, gait speed, physical function, and stress. These evaluations will be done from the start through the eighth week. Researchers will also monitor factors like peripheral neuropathy and habitual physical activity. The total involvement period is eight weeks, during which participants will complete questionnaires and physical assessments to understand how the walking exercises affect their fatigue and overall well-being.

CONDITIONS

Brief Title

Exercise to ReGain Stamina and Energy (The EXERGISE Study)

Who Can Participate

Age: 60Years - 105Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Consent to participate in the study
  • Female aged 60 years or older
  • Diagnosed with stage I-III invasive breast cancer
  • Cancer diagnosed in 2021 or 2022
  • Completed adjuvant therapy at least 3 months but no more than 1 year ago
  • Willing to participate in all study procedures
  • Experiencing at least moderate fatigue (raw score 4 8 on PROMIS measure)
Not Eligible

You will not qualify if you...

  • Failure to provide informed consent
  • Currently in a rehabilitation program
  • Absolute contraindications to exercise training
  • Significant cognitive impairment
  • Progressive degenerative neurological disease
  • Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
  • Other serious health conditions impairing exercise participation
  • Pregnant
  • Regular use of nicotinamide riboside supplement
  • Participation in other interventional studies
  • No or very mild fatigue (raw score 3 7 in PROMIS)
  • Diagnosis in past 3 years of coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, COPD, chronic bronchitis, arthritis, diabetes, or chronic kidney disease
  • Use of oral or intravenous antibiotics within 4 weeks before screening
  • Use of probiotics within 4 weeks before screening
  • History of active HIV, hepatitis B, or hepatitis C treatment
  • Positive stool tests for certain infections
  • Excessive alcohol use or abuse
  • Substance abuse in past 3 years
  • Smoking history in past 3 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants complete an 8-week walking exercise intervention either at a center 3 days per week or at home 5 days per week to reduce fatigue and improve physical function.

Weekly visits for up to 8 weeks

Trial Site Locations

Total: 1 location

1

Institute on Aging; University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors.

H J G Abrahams, M F M Gielissen, I C Schmits...

https://pubmed.ncbi.nlm.nih.gov/26940687

Postdiagnosis Physical Activity: Association With Long-Term Fatigue and Sleep Disturbance in Older Adult Breast Cancer Survivors.

Alexi Vasbinder, Kerryn W Reding, Di Wang...

https://pubmed.ncbi.nlm.nih.gov/32678375