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

NCT03580759 | Completed DMC

• 1 other identifier: 0407-18-FB
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. 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. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first study to apply low-intensity exergaming to a pre-operative advanced HF/MCC population. The successful application of this intervention has significant implications to the pre-operative conditioning of individuals with advanced HF/MCC prior to LVAD implantation or OHT.

Conditions

Heart-Assist Devices; Heart Failure NYHA Class IV; Exercise Training

Outcome Measures

Primary Outcomes (3)

• Change in Functional Capacity from Baseline

  Functional capacity will be assessed with a six-minute walk test. Subjects will be asked to walk for 6 min to determine what distance they can accomplish in that time period at a normal walking pace.

  Baseline, 1 month post-intervention, 1 & 3 months post-surgery

• Change in Physical Frailty from Baseline

  Physical frailty will be assessed using the Fried criteria which include: Unintentional weight loss (10 lbs in past year), exhaustion, weakness (grip strength), slow walking speed, and low physical activity (0 criteria-not frail; 1-2 criteria-pre-frail; ≥3-frail)

  Baseline, 1 month post-intervention, 1 & 3 months post-surgery

• Change in Fatigue from Baseline

  Fatigue will be assessed with the NINR Fatigue Common Data Element which is a 6-item self-report 5-item Likert scale. Higher scores indicate greater feelings of fatigue. Max score is 30.

  Baseline, 1 month post-intervention, 1 & 3 months post-surgery

Secondary Outcomes (1)

• Change in Immune Function from Baseline

  Baseline, 1 month post-intervention, 1 & 3 months post-surgery

Study Arms (2)

Exergaming

EXPERIMENTAL

Subjects in the exergaming group will participate in three exergaming training sessions with the Wii Fit U exergaming system. The Wii Fit U will then be left in the subjects' homes for a minimum of four weeks prior to left ventricular assist device implantation or heart transplant.

Behavioral: PREHAB

Usual Care

NO INTERVENTION

Subjects in the usual care group will be encouraged to partake in physical activity as recommended in the 2017 AHA/ACC/HFSA guidelines for heart failure.

Interventions

PREHAB BEHAVIORAL

After three supervised training sessions, subjects will be asked to participate in a daily exergaming activity tailored to their physical activity capabilities and needs. Subjects will be taught to rate their perceived exertion and monitor their target heart rate using a Fit Bit Charge HR. Daily exercise diaries will be used to monitor subject-perceived progress throughout the intervention period.

Exergaming

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• age\>19 years
• the ability to speak and understand English

You may not qualify if:

• 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)
• Unwillingness to participate in the supervised exergaming training sessions
• Unwillingness to participate in final qualitative interview

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Study Officials

• Windy W Alonso, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 9, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)