Clinical trial NCT05778747: Feasibility of the Heart to Heart Yoga Program
Official title: Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Caregiver Burden
Depression
Anxiety
Stress
Keywords: Caregiver
Yoga
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Sleep Quality
timeFrame: 12 weeks
measure: Sleep Quality
timeFrame: 12 weeks
measure: C Reactive Protein
timeFrame: 12 weeks
measure: Interleukin 6
timeFrame: 12 weeks
measure: Brain Derived Neurotrophic Factor
timeFrame: 12 weeks
measure: Perceived Symptoms
timeFrame: 12 weeks
measure: Perceived Symptoms
timeFrame: 12 weeks
measure: Depressive Symptoms
timeFrame: 12 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: Stress
timeFrame: 12 weeks
measure: Stress
timeFrame: 12 weeks
measure: Caregiver Burden
timeFrame: 12 weeks
measure: Caregiver Burden
timeFrame: 12 weeks
measure: Caregiver Burden
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Misook Chung, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: