Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04974541 |
| Other study ID # |
21-002384 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research is to see if Heart Health Yoga (HHY) Program when added on to
standard cardiac rehabilitation (CR) will improve overall wellbeing and quality of life for
patients experiencing ischemic heart disease, heart problems caused by narrowed heart
arteries.
Description:
The overarching aim of this project is to evaluate the impact of adding a novel
digitally-delivered wellbeing intervention, namely the Heart Health Yoga (HHY) program, on
overall wellbeing and quality of life (QoL), cardiovascular risk markers, adherence to
therapy, sleep quality, and recurrent hospitalizations amongst ischemic heart disease (IHD)
patients undergoing cardiac rehabilitation (CR). This aim will be addressed through the
following objectives:
Objective 1: Assess the clinical efficacy of the added digitally delivered HHY program
compared to standard psychosocial intervention alone on overall wellbeing and QoL amongst IHD
patients undergoing CR.
Aim 1 (Primary): To evaluate and compare the impact of the added digitally delivered HHY
program versus standard psychosocial intervention alone on wellbeing and QoL, as assessed
using the MacNew heart disease questionnaire, amongst IHD patients undergoing CR.
Objective 2: Assess the benefit of the added digitally delivered HHY program compared to
standard psychosocial intervention alone on cardio-metabolic risk, therapy adherence, sleep
quality, and recurrent hospitalization amongst IHD patients undergoing CR.
Aim 2 (Secondary): Assess and compare the impact of the added digitally delivered HHY program
versus standard psychosocial intervention alone on cardio-metabolic risk (i.e. hs-CRP, AM
cortisol, body weight, waist circumference, heart rate and blood pressure), therapy adherence
(via weekly compliance questionnaire for HHY group, Medication Adherence Report Scale
[MARS-5], Fitbit activity tracker), exercise capacity (6 minute walk test) and muscular
strength (hand grip testing), sleep quality (measured using Fitbit), and recurrent
hospitalizations (determined by 1 year hospital re-admission rates) amongst IHD patients
undergoing CR.
Hypothesis: Amongst IHD patients undergoing CR, compared to current standard psychosocial
interventions addition of a digitally delivered wellbeing technology will result in: 1)
greater improvements in overall wellbeing and quality of life; 2) a more profound reduction
in cardio-metabolic risk; 3) greater therapy adherence and improved sleep quality; 4) greater
increase in physical activity and/or exercise capacity; and 5) reduced incidence of recurrent
hospitalizations.
Innovation: There is sparse evidence available on digitally delivered psychosocial
interventions for CR patients. A recent meta-analysis highlighted the feasibility and
benefits of web and mobile-based delivery of cardiac rehabilitation interventions on healthy
lifestyle changes, quality of life and re-hospitalizations; however, the evidence was of
low-moderate quality. The authors also highlighted the limited evidence pertaining to
psychological wellbeing and overall cardiovascular risk markers [23]. Yet another
meta-analysis concluded that while eHealth is a feasible option for secondary prevention
amongst patients with coronary artery disease, much heterogeneity remains regarding modes of
delivery and outcome assessment. Only 6 out of 24 studies in this meta-analysis looked at
psychosocial outcomes in addition to other traditional cardiovascular outcomes [24]. Based on
the aforementioned considerations, it is clear that despite the potential clinical efficacy
of well delivered psychosocial interventions on overall wellbeing, QoL, CV risk and outcomes,
the direct impact of such interventions are chronically understudied. This will be the first
study to assess the impact of individually delivered digital wellbeing technology namely
"Heart Health Yoga (HHY)", on wellbeing and QoL improvement amongst IHD patients undergoing
CR.
Approach: The Mayo Clinic CP Rehab program graduates ~200 cardiovascular disease patients per
year, ~35% being post-PCI. We will recruit a convenience sample of these patients' over 12
months. Patients who consent to take part in this research will be allocated at random (1:1)
to one of two groups: 1) cardiac rehabilitation plus "Heart Health Yoga (HHY)" or 2) cardiac
rehabilitation with standard psychosocial education component. We will exclude those with
cognitive impairment or those on antipsychotic medications. In addition to routine CR
baseline assessments, baseline wellbeing and QoL will be assessed using the MacNew heart
disease questionnaire. Outcome measures upon completion of CR will include changes in 1)
Wellbeing/QoL scores, 2) Cardio-metabolic markers (hs-CRP, cortisol, body weight, waist
circumference, BP, HR); 3) Therapy adherence (via weekly compliance questionnaire for HHY
group, Medication Adherence Report Scale [MARS-5], Fitbit step tracker), exercise capacity
(measured by 6 min walk distance) and muscular strength (measured by hand grip testing), 4)
Sleep quality (measured using Fitbit) & 4) Recurrent hospitalizations at 1 year
Methods:
This is a prospective single blind randomized pilot study comparing the effects of digitally
delivered HHY program vs. standard psychosocial intervention on wellbeing/QoL,
cardio-metabolic risk markers, therapy adherence and recurrent hospitalizations amongst IHD
patients undergoing CP rehab. Eligible participants will be recruited at their first CR visit
with prospective enrollment.
Recruitment:
Patients will be recruited for the study at the time of their first visit to cardiac
rehabilitation. Cardiac rehabilitation staff will offer patients the option to participate in
the study and obtain consent.
Participants will need to consent to blood draws before and after the study.
Enrollment:
Interested participants will be scheduled for an initial appointment to confirm eligibility
criteria, obtain consent, randomization and baseline testing Visit 1. Randomization will be
done stratified on Charlson Comorbidity Index (CCI) categories (mild = CCI 1-2; moderate =
CCI 3-4; severe = CCI 5 or more). To ensure near balance in the number of patients in each
study arm throughout the trial, we will used blocked randomization within each CCI category
randomization patients to either HHY or standard of care in a 1:1 fashion with random block
sizes of 2 or 4 patients. Investigators and statistician will be blinded to participant
groups until after study completion and analysis of the primary endpoint.
Consent: Participants must sign the informed consent form prior to being enrolled in the
study.
Assignment: Participants will be assigned to one of the two CR groups (online HHY
intervention + Standard psychosocial intervention or standard psychosocial intervention only
control group).
- The HHY + Standard psychosocial care group participants will complete 6 online modules
(12-25 minutes in length) sequentially on their own time between weeks 3-5. The length
of time to perform all the recommended Hatha Yoga practices daily will be less than 30
minutes. For the 12-week duration of the study, Hatha Yoga Practices will be completed
at least once daily. It is recommended for the participants to perform guided meditation
sessions at least twice weekly. There will be 2 online group sessions available to
participants for guided practice sessions. These will be timed between weeks 6-7.
- The control group is the standard psychosocial care group who will receive standard
brief education/advice on psychosocial wellbeing and stress reduction.
Baseline testing Visit 1: Once consented, subjects will undergo a baseline assessment.
Baseline testing will be performed ~1-2 weeks prior to the start of digital HHY training.
Baseline data collection will include height, weight, waist and hip circumference, 6 minute
walk test distance, overnight fasting blood draw (cardio-metabolic biomarkers), resting blood
pressure and heart rate, hand grip testing and questionnaires (Table 1). Most of the study
activities will occur in CR.
Baseline questionnaires will include- MacNew Heart Disease questionnaire, Medication
adherence Report Scale [MARS-5], Brief Resilience Scale and Adverse Childhood Experience
questionaire. Questionnaires will be completed electronically (i.e. REDCap) or on paper.
Paper data will be securely stored with locked access only accessible by relevant study
personnel.
This study will utilize a commercially available wearable device (i.e. Fitbit Inspire 2)
along with the research platform Fitabase to obtain sleep and activity data for 2 months on
the participants. Fitbit will be mailed to participants and they will be asked to wear device
as often as they can during the observation period. The participants will be able to control
the Fibit.com user account (uses their own email/password) associated with the Fitbit device.
They will be asked to authorize the Fitabase system via an email to access their Fitbit data
and make it available for download for analysis. As appreciation for their participation,
participants may keep the Fitbit device for personal use after the study period. Data will be
collected via Fitabase research platform which is secure
(https://www.fitabase.com/resources/knowledge-base/working-with-the-irb/). Data will be
examined for objective sleep and activity parameters.
Weekly compliance questionnaires will be sent to the HHY intervention group starting week 3,
to assess compliance with practices.
Visit 2 at 6 weeks:
Data collection will include height, weight, waist and hip circumference, resting blood
pressure and heart rate, hand grip testing, and 6-minute walk test distance and parameters.
Questionnaires will be completed (MacNew Heart Disease questionnaire, Medication adherence
Report Scale [MARS-5],).
Visit 3 at 8 weeks:
Post CR testing will be performed within 1 week following the final CR session. Visit 3 data
collection will include height, weight, waist and hip circumference, 6-minute walk test
distance and parameters, resting blood pressure and heart rate and hand grip testing.
Questionnaires will be completed (MacNew Heart Disease questionnaire, Medication adherence
Report Scale [MARS-5]).
Visit 4 at 12 weeks:
Visit 4 data collection will include height, weight, waist and hip circumference,
temperature, 6-minute walk test distance and parameters, overnight fasting blood draw
(cardio-metabolic markers), resting blood pressure and heart rate and hand grip testing.
Questionnaires will be completed (MacNew Heart Disease questionnaire, Medication adherence
Report Scale [MARS-5]).
Other Follow-up If subjects are not able to complete the questionnaires at the visit, we can
send them postage paid return envelope, follow-up by e-mail or be telephone in attempt to
receive missing data.
Subjects may be contacted by telephone to remind them of their follow-up appointments, or to
troubleshoot the devices, or to remind them to follow the HHY program.
Remuneration Subjects will not receive any remuneration for participation in the study.
