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Completed

NCT Number: NCT05778747

Feasibility of the Heart to Heart Yoga Program

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.

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Key information

Conditions

Heart Failure Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Caregiver Burden Depression Heart Diseases Mental Disorders Stress Stress, Psychological

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40503, United States

About this study

Heart2Heart Intervention. In this study, 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 heart failure (HF) and family caregivers who may have physical limitations and to fit cultural and social norms in Kentucky. The Heart to Heart Yoga intervention key personnel include two primary investigators, two professional yoga instructors, and one PhD student who are all nurses and were certified Medi-Yoga instructor Level 1 by completing more than 120 hours of Medi-yoga training course for medical professionals. 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. In the recent systematic literature review, yoga has been delivered for 12 weeks in patients with HF. The the12-week duration was selected in this study by considering variations of individual adaptation and available evidence in the literature. Yoga sessions will be delivered by two registered nurses who were yoga instructors and certified MediYoga instructors.

The 12-weeks of intervention include three structured sessions. At each session, the first part will focus on deep breathing (5- 11 minutes), followed by physical posture movement (3 -11 minutes), and then meditation (6 -11 minutes), based on the structured gradual adaptation program. Participants will be instructed to modify movements to ensure comfort and safety. For example, if a participant is more comfortable seated in a chair instead of the floor, the instructor will demonstrate exercise modification while ensuring target muscles are utilized. All sessions will be delivered as group sessions using a video-conferencing program on a digital multimedia device. Each week, three yoga sessions are available to allow participants flexibility in attendance. The intervention group also receives a short-video clip each week (up to 10 minutes) and recommend to follow to practice yoga for 10 minutes per day, and a total of 50 minutes per week while not attending sessions. Participants will record practice time in a Yoga log booklet.

The investigators will limit the number of participants up to 10 at each session by monitoring enrollment rates. Participants will also receive materials that include yoga poses guides and mats. Without explicit skill demonstration and training, the intervention group will receive the printed information and links to the AHA's Life's Simple 7 program.

Usual Care Group. 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. Stress management will be encouraged by watching and practicing yoga programs by providing a yoga mat.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients:

  • diagnosis of chronic HF confirmed by their cardiologist with either preserved or reduced ejection fraction
  • be able to speak and write English.

Inclusion criteria

Caregivers:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Intervention

    Time frame: 12 weeks

    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).

  2. Physical activity

    Time frame: 12 weeks

    Sit and stand

  3. Physical activity

    Time frame: 12 weeks

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

  4. Sleep Quality

    Time frame: 12 weeks

    Pittsburgh Sleep Quality Index

  5. Sleep Quality

    Time frame: 12 weeks

    Actigraphy data

  6. C Reactive Protein

    Time frame: 12 weeks

  7. Interleukin 6

    Time frame: 12 weeks

  8. Brain Derived Neurotrophic Factor

    Time frame: 12 weeks

  9. Perceived Symptoms

    Time frame: 12 weeks

    Heart Failure Somatic Symptom Checklist

  10. Perceived Symptoms

    Time frame: 12 weeks

    Memorial Symptoms Assessment Scale

  11. Depressive Symptoms

    Time frame: 12 weeks

    Patient Health Questionnaire-9 (PHQ-9)

  12. Anxiety

    Time frame: 12 weeks

    Hospital Anxiety and Depressive Symptoms Scale (HADS)

  13. Stress

    Time frame: 12 weeks

    Cohen's Perceived Stress Scale

  14. Stress

    Time frame: 12 weeks

    Salivary cortisol awakening response

  15. Caregiver Burden

    Time frame: 12 weeks

    Zarit Burden Interview (ZBI)

  16. Caregiver Burden

    Time frame: 12 weeks

    Oberst Caregiving Burden Scale (OCBS)

  17. Caregiver Burden

    Time frame: 12 weeks

    Caregiving Burden Questionnaire for heart failure (CBQ-HF)

  18. Quality of Life

    Time frame: 12 weeks

    European Quality of Life (EQ-5D)

  19. Quality of Life

    Time frame: 12 weeks

    Minnesota Living with Heart failure (MLHFQ)

Sponsors and collaborators

Lead sponsor

Misook L. Chung

Other

Registry information

Official study title

Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers

Acronym: H2HYoga

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Nov 30, 2023

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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