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Enrolling by Invitation

NCT Number: NCT06434168

Impact of Yoga on Cognitive Function

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Brain structure

    Time frame: 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.

  2. Brain functional connectivity

    Time frame: 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.

  3. Cognitive function

    Time frame: 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.

  4. Serum brain-derived neurotrophic factor

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • Edward Via College of Osteopathic Medicine, Auburn campus

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 30, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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