Impact of Yoga on Cognitive Function

NCT06434168 | Not Yet Recruiting

• 1 other identifier: AU-24-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Mild Cognitive Impairment

Keywords

Yoga intervention; cognitive function

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Yoga intervention

EXPERIMENTAL

Behavioral: Yoga intervention

Control condition

PLACEBO COMPARATOR

Behavioral: Control condition

Interventions

Yoga intervention BEHAVIORAL

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.

Yoga intervention

Control condition BEHAVIORAL

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.

Control condition

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55 years and older
• Confirmed heart failure diagnosis with mild cognitive impairment
• New York Heart Association functional class II-IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead
• VCOM, Auburn campus: collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Chin-Yen Lin, RN, PhD

CONTACT

334-844-5619; czl0194@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)