NCT04898790Recruiting
Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population. The study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners. The second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 7 May 2021
- Start date
- Nov 2021
- Primary completion date
- Jul 2027
- Lead sponsor
- University of Nebraska
- NCT number
- NCT04898790
What you commit to
- Study type: Interventional
- Planned participants: 114
- From Nov 2021 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma)
Other illness
- Myocardial infarctions in the past 3 months
- Resting or unstable angina
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
- other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition
- (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes):
- history of major stroke with obvious residual deficits
- history of relapsing and remitting Multiple Sclerosis
- active moderate to severe psychiatric symptoms due to primary psychiatric disorder
- Myocardial infarctions in the past 3 months
- Resting or unstable angina
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition
Lab values
- is not cleared to participate in exercise by a physician
- Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
- Acute congestive heart failure or ejection fraction \<30%
- Clinically significant aortic stenosis
- Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
- is not cleared to participate in exercise by a physician
- Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
- Acute congestive heart failure or ejection fraction \<30%
- Clinically significant aortic stenosis
- Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
- o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
Other
- there are no exclusion criteria
- there are no exclusion criteria
- there are no exclusion criteria
- Arms 2 and 3:
- development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
- development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
- there are no exclusion criteria
Who the study is looking for
- age 60 years and older
- have a diagnosis of hematological malignancy
- have received autologous or allogeneic HCT within the prior 3-6 months
- able to speak and read English
- have provided written informed consent
- age 19 years and older
- able to speak and read English
- age 19 years and older
- able to speak and read English
- age 55 years and older
- have a diagnosis of hematological malignancy
- planned to receive an autologous or allogeneic HCT
- able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
- (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned
- able to speak and read English
- have provided written informed consent
- age 19 years and older
- able to speak and read English
- able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
- have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form
- age 19 years and older
- able to speak and read English
Criteria the registry did not label
- Arm 1:
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.