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Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)

Launched by UNIVERSITY OF ROCHESTER · Aug 19, 2020

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

The BREATHE trial is studying a new approach to help older adults with mild cognitive impairment (MCI), which is a condition that can affect memory and thinking skills. Researchers want to see if combining breathing exercises with a specific cognitive training program can improve brain function and slow down the progression of dementia. The study will involve 114 participants who are randomly assigned to either the combined program, a control group that only receives cognitive training with relaxation techniques, or a waitlist group. Participants can expect to take part in an 8-week program with follow-up sessions over 14 months, during which their cognitive abilities and overall health will be monitored.

To be eligible, participants must be between 60 and 89 years old, speak English, and have a diagnosis of mild cognitive impairment. They should also have stable medication for at least three months and be living independently. However, those currently in other cognitive studies, with severe depression, or certain medical conditions will not be included. The trial aims to enhance our understanding of how to best support cognitive health in older adults and may offer new ways to help manage the effects of MCI.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. All participants will require a diagnosis of "mild cognitive impairment due to Alzheimer's disease"using the most recent NIA and Alzheimer's Association workshop criteria:
  • 1. Presence of memory complaint,
  • 2. Rey Auditory Verbal Learning Test delayed recall (for memory) \< 6,
  • 3. Montreal Cognitive Assessment (for global cognition) ranged 18 and 25,
  • 4. Activities of Daily Living Questionnaire ≤ 30,
  • 2. Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
  • 3. If a participant is on Alzheimer's disease medication (i.e., memantine or cholinesterase inhibitors), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta- blocker), the dose should be stable for 3 months prior to recruitment.
  • 4. Age 60-89,
  • 5. English-speaking,
  • 6. Adequate visual and hearing acuity for using mobile-based apps and testing by self-report, and
  • 7. Community-dwelling.
  • Exclusion Criteria:
  • 1. Current enrollment in another cognitive improvement study;
  • 2. Uncontrollable symptoms of major depression;
  • 3. Major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
  • 4. Neurological diseases (e.g., Parkinson's disease, Multiple Sclerosis);
  • 5. Having an active legal guardian (indicating impaired capacity for decision making);
  • 6. MRI contraindication (e.g., pacemaker, claustrophobia).
  • 7. Color blindedness
  • 8. Alcohol dependency in the past 5 years that are the main contributor to MCI

About University Of Rochester

The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.

Locations

Rochester, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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