Feasibility of the Heart to Heart Yoga Program

NCT05778747 | Completed

• 1 other identifier: 72684
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A two-group (intervention vs. usual care), randomized controlled design will be used to determine the feasibility and acceptability of the intervention, the Heart2Heart program, and determine efficacy on physical and psychological outcomes in patients with heart failure (HF) and caregivers. A total of 20 patients with HF and 20 caregivers (n= 40) will be randomly assigned to the intervention or usual care group stratified by patient and caregiver groups. Only participants in the intervention will be asked to attend the 12-week sessions (two sessions per week; a total of 24 sessions in 12 weeks) via video conferencing (i.e., ZOOM). The short-term intervention efficacy will be assessed following week of the completion of 12-weeks sessions. Primary psychological outcomes include depressive symptoms, anxiety, stress, and quality of life. Primary physical outcomes include physical activity level, sleep quality, and perceived symptoms.

Conditions

Heart Failure; Caregiver Burden; Depression; Anxiety; Stress

Keywords

Caregiver; Yoga

Outcome Measures

Primary Outcomes (19)

• Feasibility of Intervention

  Intervention evaluations will include a Likert style questionnaire to assess feasibility. Open-ended questions and comments will be utilized to gather additional information on any barriers or facilitators of participation and completion. feasibility data will be collected by each group's recruitment and retention rates by tracking eligible and enrolled participants using the consort diagram. We will also track participants' attendance rates and total attendance time (minutes) by monitoring the recorded sessions for the intervention acceptability. We will also collect participants' intervention satisfaction, enjoyment of the session, willingness to engage in yoga at home, and difficulty following yoga instruction using an 11-point numeric analog scale (0= not at all,10= very much) each session. We will also collect the Treatment Acceptability Adherence Scale (TAAS) and the Client Satisfaction Questionnaire (CSQ).

  12 weeks

• Physical activity

  Sit and stand

  12 weeks

• Physical activity

  Activity energy expenditure using accelerometer of activity monitor device (ActiGraph)

  12 weeks

• Sleep Quality

  Pittsburgh Sleep Quality Index

  12 weeks

• Sleep Quality

  Actigraphy data

  12 weeks

• C Reactive Protein

  12 weeks

• Interleukin 6

  12 weeks

• Brain Derived Neurotrophic Factor

  12 weeks

• Perceived Symptoms

  Heart Failure Somatic Symptom Checklist

  12 weeks

• Perceived Symptoms

  Memorial Symptoms Assessment Scale

  12 weeks

• Depressive Symptoms

  Patient Health Questionnaire-9 (PHQ-9)

  12 weeks

• Anxiety

  Hospital Anxiety and Depressive Symptoms Scale (HADS)

  12 weeks

• Stress

  Cohen's Perceived Stress Scale

  12 weeks

• Stress

  Salivary cortisol awakening response

  12 weeks

• Caregiver Burden

  Zarit Burden Interview (ZBI)

  12 weeks

• Caregiver Burden

  Oberst Caregiving Burden Scale (OCBS)

  12 weeks

• Caregiver Burden

  Caregiving Burden Questionnaire for heart failure (CBQ-HF)

  12 weeks

• Quality of Life

  European Quality of Life (EQ-5D)

  12 weeks

• Quality of Life

  Minnesota Living with Heart failure (MLHFQ)

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

A total of 20 patients with HF and 20 caregivers (n= 40) who have at least mild depressive symptoms (Patient Health Questionnaire 9 \[PHQ-9\] score = 5) will be randomly assigned to the intervention or usual care group stratified by patient and caregiver groups (Figure 1). Only participants in the intervention will be asked to attend the 12-week sessions (two sessions per week; a total of 24 sessions in 12 weeks) via video conferencing (i.e., ZOOM). The short-term intervention efficacy will be assessed at the following week of the completion of 12-weeks sessions. Primary psychological outcomes include depressive symptoms, anxiety, stress, and quality of life. Primary physical outcomes include physical activity level, sleep quality, and perceived symptoms.

Other: Heart to Heart Yoga

Usual Care

NO INTERVENTION

Participants in the usual care group will also receive the printed information and links to the AHA's Life's Simple 7 program without explicit skills and training, including education and stress management. We will encourage stress management by watching and practicing yoga programs by providing a yoga mat.

Interventions

Heart to Heart Yoga OTHER

The Heart to Heart Yoga intervention is a therapeutic and standardized form of yoga intervention that is adapted from MediYoga designed to fit the needs of patients with HF and family caregivers who have physical limitations and depressive symptoms and to fit cultural and social norms in Kentucky. The intervention will use a gradual, physical/ psychological yoga adaptation approach, and it will be delivered two times per week (40 -60 minutes per session) via videoconference technology for 12 weeks (total 24 sessions). Real-time, face-to-face, video conferencing technology is used.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of chronic HF confirmed by their cardiologist with either preserved or reduced ejection fraction
• be able to speak and write English.
• be a primary caregiver identified by the patient
• the spouse, committed partner, or family member living with the HF patient
• be able to speak and understand English
• ability to give informed consent
• have no major comorbidities (i.e., HF, and terminal illness including active cancer, renal/liver failure) to perform yoga practice.

You may not qualify if:

• After obtaining the signed consent, we will screen depressive symptoms using the 9-items of the Patient Health Questionnaire (see the detailed process of screening depressive symptom criterion in the procedure) because we will target only patients and caregivers who experience at least mild depressive symptoms.
• major clinical cognitive impairment (i.e., dementia, Alzheimer's disease, and severe stroke)
• co-existing terminal illness (e.g., cancer)
• major psychiatric disorder other than depression
• referral for heart transplantation.

Sponsors & Collaborators

• Misook L. Chung: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40503, United States

Location

MeSH Terms

Conditions

Heart Failure; Caregiver Burden; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Misook Chung, PhD, RN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: March 21, 2023
• Study Start: October 15, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)