Heart Failure, Mild Cognitive Impairment
Conditions
Keywords
Yoga intervention, cognitive function
Brief summary
Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.
Detailed description
A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).
Interventions
BEHAVIORALYoga intervention
Patients in the yoga group will receive a 60-minute session, twice per week over 12 weeks for a total of 24 sessions. Each yoga session consists of a warm-up, yoga postures standing or seated depending on the capability of the patient, and relaxation.
BEHAVIORALControl condition
Patients in the control group will receive care-as-usual from their healthcare providers and will be asked to avoid engaging in yoga during their 3 months in the study.
Sponsors
Auburn University
Edward Via College of Osteopathic Medicine, Auburn campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 55 years and older * Confirmed heart failure diagnosis with mild cognitive impairment * New York Heart Association functional class II-IV
Exclusion criteria
* Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses * Have implanted defibrillator, left ventricular assist device placement or cardiac transplant * Have any other implanted metals that interfere with the MRI magnetic field for patient safety * Substance abuse * Pregnant * Unable to perform yoga due to physical limitations or severity of illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain structure | Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention | Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal. |
| Brain functional connectivity | Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention | Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups. A balance of activity across different brain regions is optimal. |
| Cognitive function | Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention | Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function. |
| Serum brain-derived neurotrophic factor | Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention | A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg/mL. Higher concentrations are optimal. |
Countries
United States
Outcome results
None listed