Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant

Specific Aims. The objectives of this study are two-fold: (1) To test the feasibility of a
low intensity, home-based exergaming intervention in individuals with advanced HF/MCC prior
to left ventricular assist device (LVAD) implantation or orthotopic heart transplantation
(OHT), and (2) To examine the effectiveness of delivering a low intensity, home-based
exergaming intervention to decrease frailty and fatigue and improve affective well-being,
functional capacity, and immune function in individuals with advanced HF/MCC prior to
receiving an LVAD or OHT.

Other surgical populations who were deconditioned, fatigued, and frail before surgery have
benefited from the use of pre-surgical fitness interventions (prehabilitation).3-5 Innovative
interventions strategies, like the Nintendo Wii Fit exergaming system, have been successful
at engaging seriously ill adults in low-intensity physical activity6,7. However, exergaming
interventions have not yet been applied in individuals with advanced HF as prehabilitation
prior to LVAD implantation or OHT. The investigators propose that a home-based,
prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will
also augment postoperative outcomes.

The investigators will conduct this study in two phases. Phase 1 is designed as a feasibility
study in a smaller sample (5 participants and 5 informal caregivers) to allow initial
evaluation of the intervention including troubleshooting the technological components and
evaluating study recruitment, retention, and intervention safety prior to initiating the
larger, two-group randomized study. Phase 2 will enroll a convenience sample of 40
participants with advanced HF/MCC who are being evaluated for LVAD implantation or OHT at
Nebraska Medicine and their 40 informal caregivers for a total sample of 80 enrollees (n=40
exergaming, n=40 usual care).

In both phases, the exergaming group will participate in a low-intensity exergaming
intervention and additional investigator-developed educational modules (e.g. symptoms while
exercising, exercising with heart failure) that will be delivered via the Nintendo Wii U
exergaming system. Investigator-developed modules are designed to promote self-efficacy,
self-regulation, and activation. Individuals with advanced HF/MCC will be expected to
participate in the exergaming intervention and the investigator-developed modules. Caregivers
will be asked to be present for all training sessions and participate in the
investigator-developed modules. The investigators will evaluate pre- and post-surgical
frailty, fatigue, affective well-being, and immune function as primary outcomes in the
individuals with advanced HF/MCC. The investigators expect that participation in low
intensity exergaming will improve these primary outcomes pre- and post-surgically, and
decrease post-surgical complications and health care utilization. Relationships will be
examined among self-efficacy, self-regulation, and activation scores over time, and adherence
to the intervention to test whether self-management mechanisms were effective in promoting
adherence. Additionally, post-intervention qualitative interviews will be conducted to assess
participant and caregiver experiences with the intervention.

Specific aims of this study are the following:

Aim 1 (Phase 1): Evaluate the feasibility of the home-based, low intensity exergaming
intervention in individuals with advanced HF/MCC prior to LVAD implantation or OHT and their
informal caregivers by assessing recruitment, enrollment, acceptability, adherence, subjects
perception of barriers and facilitators, and implementation (delivery, fidelity, and
procedures for data collection).

Aim 2 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on pre- and
post-surgical outcomes: frailty, fatigue, affective well-being, immune function, and
biomarkers of co-morbid conditions at baseline, 4 weeks, and 1 and 3 months post-surgery
compared to usual care (All subjects with advanced HF/MCC).

H1. Subjects in the exergaming group will have decreased frailty and fatigue and improved
affective well-being and immune function compared to usual care.

Aim 3 (Phase 2): Evaluate the impact of home-based, low intensity exergaming on post-surgical
complications (death, infection, bleeding, and rejection) and health care utilization
(emergency department visits, unplanned hospital admissions) compared to usual care (both
groups of subjects).

H2.a. Subjects in the exergaming group will have fewer post-surgical complications compared
to usual care.

H2.b. Subjects in the exergaming group will have fewer emergency department visits and
hospital admissions compared to usual care.

Aim 4 (Phase 2): Explore relationships among self-efficacy, self-regulation, and activation
scores over time, intervention adherence, and pre- and post-surgical outcomes (Exergaming
group participants and caregivers only).

There is a critical need to address deconditioning, fatigue, and frailty in individuals with
advanced HF/MCC prior to LVAD implantation or OHT. This innovative exergaming intervention
incorporates the use of an interactive, home-based technology to improve pre-and
post-surgical outcomes

Inclusion Criteria for Participants:

- age >19 years

- diagnosis of advanced HF and a minimum of one additional co-occurring chronic
condition

- undergoing evaluation for left ventricular assist device implantation or heart
transplant

- medical clearance from a heart failure cardiologist in the Nebraska Medicine Advanced
HF Clinic.

- the ability to speak and understand English

Inclusion Criteria for Caregivers:

- age>19 years

- the ability to speak and understand English

Exclusion Criteria for Participants:

- cognitive impairment (Montreal Objective Cognitive Assessment39 [MoCA] < 26),
-neuromuscular or orthopedic impairment that would preclude low-intensity physical
activity

- unwillingness to complete two supervised sessions in the clinical setting, and one in
the home setting

- ongoing inotrope therapy. (Exercise is discouraged during inotrope therapy.)

- inability to pass a Wii Fit Balance Board safety screen (prior to randomization in
Phase 2)

Exclusion criteria for Caregivers:

- Unwillingness to participate in the supervised exergaming training sessions

- Unwillingness to participate in final qualitative interview