Heart FailureH2HYogaNCT05778747
Feasibility of the Heart to Heart Yoga Program
A study testing Heart to Heart Yoga in people with Heart Failure and Caregiver Burden, run by Misook L. Chung at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Caregiver Burden, Depression
- What is being tested?
- Heart to Heart Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers
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.
Read the 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.
- Conditions
- Heart Failure, Caregiver Burden, Depression, Anxiety, Stress
- Being tested
- Heart to Heart Yoga
- Keywords
- Caregiver, Yoga
- Medical subject headings
- Heart Failure, Caregiver Burden, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart to Heart YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Physical activity
Sit and stand
Measured: 12 weeks
Physical activity
Activity energy expenditure using accelerometer of activity monitor device (ActiGraph)
Measured: 12 weeks
Sleep Quality
Pittsburgh Sleep Quality Index
Measured: 12 weeks
Sleep Quality
Actigraphy data
Measured: 12 weeks
C Reactive Protein
Measured: 12 weeks
Interleukin 6
Measured: 12 weeks
Brain Derived Neurotrophic Factor
Measured: 12 weeks
Perceived Symptoms
Heart Failure Somatic Symptom Checklist
Measured: 12 weeks
Perceived Symptoms
Memorial Symptoms Assessment Scale
Measured: 12 weeks
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 weeks
Anxiety
Hospital Anxiety and Depressive Symptoms Scale (HADS)
Measured: 12 weeks
Stress
Cohen's Perceived Stress Scale
Measured: 12 weeks
Stress
Salivary cortisol awakening response
Measured: 12 weeks
Caregiver Burden
Zarit Burden Interview (ZBI)
Measured: 12 weeks
Caregiver Burden
Oberst Caregiving Burden Scale (OCBS)
Measured: 12 weeks
Caregiver Burden
Caregiving Burden Questionnaire for heart failure (CBQ-HF)
Measured: 12 weeks
Quality of Life
European Quality of Life (EQ-5D)
Measured: 12 weeks
Quality of Life
Minnesota Living with Heart failure (MLHFQ)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start15 Oct 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misook L. Chung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Misook L. Chung, University of Kentucky
- Investigators
- Misook Chung, PhD, RN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778747
- Sponsor's protocol ID
- 72684
- Acronym
- H2HYoga
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers
- ClinicalTrials.gov ID
- NCT05778747
- Acronym / sponsor ID
- H2HYoga / 72684
- Conditions
- Heart Failure, Caregiver Burden, Depression, Anxiety, Stress
- Keywords
- Caregiver, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Misook L. ChungUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Heart to Heart YogaA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart to Heart YogaThe 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. | Other | Intervention |
Primary outcome
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).
Physical activity
Time frame: 12 weeks
Sit and stand
Physical activity
Time frame: 12 weeks
Activity energy expenditure using accelerometer of activity monitor device (ActiGraph)
Sleep Quality
Time frame: 12 weeks
Pittsburgh Sleep Quality Index
Sleep Quality
Time frame: 12 weeks
Actigraphy data
C Reactive Protein
Time frame: 12 weeks
Interleukin 6
Time frame: 12 weeks
Brain Derived Neurotrophic Factor
Time frame: 12 weeks
Perceived Symptoms
Time frame: 12 weeks
Heart Failure Somatic Symptom Checklist
Perceived Symptoms
Time frame: 12 weeks
Memorial Symptoms Assessment Scale
Depressive Symptoms
Time frame: 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Anxiety
Time frame: 12 weeks
Hospital Anxiety and Depressive Symptoms Scale (HADS)
Stress
Time frame: 12 weeks
Cohen's Perceived Stress Scale
Stress
Time frame: 12 weeks
Salivary cortisol awakening response
Caregiver Burden
Time frame: 12 weeks
Zarit Burden Interview (ZBI)
Caregiver Burden
Time frame: 12 weeks
Oberst Caregiving Burden Scale (OCBS)
Caregiver Burden
Time frame: 12 weeks
Caregiving Burden Questionnaire for heart failure (CBQ-HF)
Quality of Life
Time frame: 12 weeks
European Quality of Life (EQ-5D)
Quality of Life
Time frame: 12 weeks
Minnesota Living with Heart failure (MLHFQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misook Chung, PhD, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart to Heart Yoga in people with Heart Failure and Caregiver Burden, run by Misook L. Chung at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: 12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.