Impact of Yoga on Cognitive Function

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Mild Cognitive Impairment
• Interventions: Behavioral: Yoga intervention; Behavioral: Control condition

• Registration Number: NCT06434168
• Lead Sponsor: Auburn University

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).

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga intervention	Yoga intervention	-
Control condition	Control condition	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Auburn University; 🇺🇸 Auburn, Alabama, United States