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Exercise to ReGain Stamina and Energy (The EXERGISE Study)

  • Status
    Accepting Candidates
  • Age
    60 Years - 105 Years
  • Sexes
  • Healthy Volunteers


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.


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.


Full study title Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
Protocol number OCR43841 ID NCT05684367
Phase N/A


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

Lead researcher

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  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Emilie Schmidt
  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.