Clinical trial · Interventional
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
NCT05684367CI-TRIAL-00102547recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Therapy-Related | Therapy-Related Malignant Neoplasm | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Center-Based Walking Exercise | Behavioral | — | UNRESOLVED |
| Home-Based Walking Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Center-Based Walking Exercise
- description
- Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.
- interventionNames
- Behavioral: Center-Based Walking Exercise
- type
- EXPERIMENTAL
- label
- Home-Based Walking Exercise
- description
- Subjects will be randomly assigned to walk for exercise in their community five days/week.
- interventionNames
- Behavioral: Home-Based Walking Exercise
Primary outcomes (1)
- measure
- Self-Reported Fatigue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 105 Years
Show eligibility criteria text
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
References
Publications (84)
- BACKGROUNDMartin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8. PMID 30044214
- BACKGROUNDDemb J, Abraham L, Miglioretti DL, Sprague BL, O'Meara ES, Advani S, Henderson LM, Onega T, Buist DSM, Schousboe JT, Walter LC, Kerlikowske K, Braithwaite D; Breast Cancer Surveillance Consortium. Screening Mammography Outcomes: Risk of Breast Cancer and Mortality by Comorbidity Score and Age. J Natl Cancer Inst. 2020 Jun 1;112(6):599-606. doi: 10.1093/jnci/djz172. PMID 31593591
- BACKGROUNDHamer J, McDonald R, Zhang L, Verma S, Leahey A, Ecclestone C, Bedard G, Pulenzas N, Bhatia A, Chow R, DeAngelis C, Ellis J, Rakovitch E, Lee J, Chow E. Quality of life (QOL) and symptom burden (SB) in patients with breast cancer. Support Care Cancer. 2017 Feb;25(2):409-419. doi: 10.1007/s00520-016-3417-6. Epub 2016 Sep 30. PMID 27696078
- BACKGROUNDPhillips RO. A review of definitions of fatigue - And a step towards a whole definition. Transport Res F-Traf. 2015;29:48-56.
- BACKGROUNDCampos MPO, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol. 2011 Jun;22(6):1273-1279. doi: 10.1093/annonc/mdq458. Epub 2011 Feb 16. PMID 21325448
- BACKGROUNDFu OS, Crew KD, Jacobson JS, Greenlee H, Yu G, Campbell J, Ortiz Y, Hershman DL. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009 Dec;3(4):241-50. doi: 10.1007/s11764-009-0100-7. Epub 2009 Oct 27. PMID 19859813
- BACKGROUNDAbrahams HJG, Gielissen MFM, Schmits IC, Verhagen CAHHVM, Rovers MM, Knoop H. Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors. Ann Oncol. 2016 Jun;27(6):965-974. doi: 10.1093/annonc/mdw099. Epub 2016 Mar 2.