Impact of Yoga on Cognitive Function

Heart Failure Clinical Trial

Official title:

A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434168
• Other study ID #: AU-24-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Auburn University
• Contact: Chin-Yen Lin, RN, PhD
• Phone: 334-844-5619
• Email: czl0194[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Heart Failure
• Mild Cognitive Impairment

Intervention

Behavioral:
• Yoga 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.
• Control 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.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	VCOM, Auburn campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain structure	Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.	Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Primary	Brain functional connectivity	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.	Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Primary	Cognitive function	Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.	Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Primary	Serum brain-derived neurotrophic factor	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.	Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention