Impact of Yoga on Cognitive Function

NCT ID: NCT06434168

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

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).

Conditions

Heart Failure; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Yoga intervention

Group Type: EXPERIMENTAL

Yoga intervention

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Control condition

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VCOM, Auburn campus

UNKNOWN

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Chin-Yen Lin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Auburn University

Auburn, Alabama, United States

Countries

United States

Central Contacts

Chin-Yen Lin, RN, PhD

Role: CONTACT

czl0194@auburn.edu

334-844-5619

Facility Contacts

Chin-Yen Lin, RN, PhD

Role: primary

czl0194@auburn.edu

334-844-5619

Other Identifiers

AU-24-001

Identifier Type: -

Identifier Source: org_study_id