search
Back to results

Feasibility of the Heart to Heart Yoga Program (H2HYoga)

Primary Purpose

Heart Failure, Caregiver Burden, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart to Heart Yoga
Sponsored by
Misook L. Chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Caregiver, Yoga

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Physical activity
Sit and stand
Physical activity
Activity energy expenditure using accelerometer of activity monitor device (ActiGraph)
Sleep Quality
Pittsburgh Sleep Quality Index
Sleep Quality
Actigraphy data
C Reactive Protein
Interleukin 6
Brain Derived Neurotrophic Factor
Perceived Symptoms
Heart Failure Somatic Symptom Checklist
Perceived Symptoms
Memorial Symptoms Assessment Scale
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9)
Anxiety
Hospital Anxiety and Depressive Symptoms Scale (HADS)
Stress
Cohen's Perceived Stress Scale
Stress
Salivary cortisol awakening response
Caregiver Burden
Zarit Burden Interview (ZBI)
Caregiver Burden
Oberst Caregiving Burden Scale (OCBS)
Caregiver Burden
Caregiving Burden Questionnaire for heart failure (CBQ-HF)
Quality of Life
European Quality of Life (EQ-5D)
Quality of Life
Minnesota Living with Heart failure (MLHFQ)

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
August 11, 2023
Sponsor
Misook L. Chung
search

1. Study Identification

Unique Protocol Identification Number
NCT05778747
Brief Title
Feasibility of the Heart to Heart Yoga Program
Acronym
H2HYoga
Official Title
Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Misook L. Chung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Caregiver Burden, Depression, Anxiety, Stress
Keywords
Caregiver, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Heart to Heart Yoga
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of Intervention
Description
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).
Time Frame
12 weeks
Title
Physical activity
Description
Sit and stand
Time Frame
12 weeks
Title
Physical activity
Description
Activity energy expenditure using accelerometer of activity monitor device (ActiGraph)
Time Frame
12 weeks
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index
Time Frame
12 weeks
Title
Sleep Quality
Description
Actigraphy data
Time Frame
12 weeks
Title
C Reactive Protein
Time Frame
12 weeks
Title
Interleukin 6
Time Frame
12 weeks
Title
Brain Derived Neurotrophic Factor
Time Frame
12 weeks
Title
Perceived Symptoms
Description
Heart Failure Somatic Symptom Checklist
Time Frame
12 weeks
Title
Perceived Symptoms
Description
Memorial Symptoms Assessment Scale
Time Frame
12 weeks
Title
Depressive Symptoms
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
12 weeks
Title
Anxiety
Description
Hospital Anxiety and Depressive Symptoms Scale (HADS)
Time Frame
12 weeks
Title
Stress
Description
Cohen's Perceived Stress Scale
Time Frame
12 weeks
Title
Stress
Description
Salivary cortisol awakening response
Time Frame
12 weeks
Title
Caregiver Burden
Description
Zarit Burden Interview (ZBI)
Time Frame
12 weeks
Title
Caregiver Burden
Description
Oberst Caregiving Burden Scale (OCBS)
Time Frame
12 weeks
Title
Caregiver Burden
Description
Caregiving Burden Questionnaire for heart failure (CBQ-HF)
Time Frame
12 weeks
Title
Quality of Life
Description
European Quality of Life (EQ-5D)
Time Frame
12 weeks
Title
Quality of Life
Description
Minnesota Living with Heart failure (MLHFQ)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misook Chung, PhD, RN
Phone
8593238024
Email
misook.chung@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misook Chung, PhD, RN
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misook Chung, PhD, RN
Phone
859-323-8024
Email
misook.chung@uky.edu
First Name & Middle Initial & Last Name & Degree
Misook Chung, PhD, RN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility of the Heart to Heart Yoga Program

We'll reach out to this number within 24 hrs