## Protocol Section
### Identification Module
**NCT ID:** NCT06434168

**Brief Title:** Impact of Yoga on Cognitive Function

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

#### Organization Study ID Info
**ID:** AU-24-001
#### Organization
**Class:** OTHER
**Full Name:** Auburn University
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** VCOM, Auburn campus

#### Lead Sponsor

**Class:** OTHER

**Name:** Auburn University

#### Responsible Party

**Investigator Affiliation:** Auburn University

**Investigator Full Name:** Chin-Yen Lin

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Heart Failure

- Mild Cognitive Impairment

**Keywords:**

- Yoga intervention

- cognitive function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Yoga intervention

**Label:** Yoga intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Control condition

**Label:** Control condition

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Yoga intervention

**Description:** 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.

**Name:** Yoga intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control condition

**Description:** 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.

**Name:** Control condition

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.

**Measure:** Brain structure

**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention

**Description:** 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.

**Measure:** Brain functional connectivity

**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention

**Description:** Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.

**Measure:** Cognitive function

**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention

**Description:** 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.

**Measure:** Serum brain-derived neurotrophic factor

**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 55 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** czl0194@auburn.edu

**Name:** Chin-Yen Lin, RN, PhD

**Phone:** 334-844-5619

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Auburn

**Contacts:**

***Contact 1:***

- **Email:** czl0194@auburn.edu

- **Name:** Chin-Yen Lin, RN, PhD

- **Phone:** 334-844-5619

- **Role:** CONTACT

**Country:** United States

**Facility:** Auburn University

**State:** Alabama

**Zip:** 36849

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000003072

- Term: Cognition Disorders

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Mild Cognitive Impairment

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

- ID: D000060825

- Term: Cognitive Dysfunction

### Misc Info Module

- Version Holder: 2024-05-31
