NCT03580759: PREHAB-HF

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

Completed NA Last updated 29 September 2023

What this trial tests

NA trial testing PREHAB in Heart-Assist Devices in 2 participants. Completed in 1 March 2021.

Timeline

1 March 2019

Primary endpoint
1 March 2021

1 March 2021

Quick facts

Lead sponsor	University of Nebraska
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	2
Start date	1 March 2019
Primary completion	1 March 2021
Estimated completion	1 March 2021
Sites	1 location across United States

Drugs / interventions tested

• PREHAB

Conditions studied

• Heart-Assist Devices — all drugs for Heart-Assist Devices →
• Heart Failure NYHA Class IV — all drugs for Heart Failure NYHA Class IV →
• Exercise Training — all drugs for Exercise Training →

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Heart-Assist Devices or Heart Failure NYHA Class IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.
   Purcell C, Dibben G, Hilton Boon M, Matthews L, et al · · 2023 · cited 17× · PMID 37378598 · DOI 10.1002/14651858.cd013820.pub2