Effects of Exergame in Patients at High Cardiovascular Risk.

NCT04042896 | Completed

• 1 other identifier: EXERHEART
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Exergaming is thought to have a similar effect on cardiovascular (CV) responses as aerobic fitness activities. The aim of this study was to compare the cardiovascular effects of exergaming and traditional treadmill exercises in patients with high CV risk. Methods: Sixty-four patients with high CV risk were randomized among exergame (EG: n = 22), treadmill (TM: n = 22), and control (n=20) groups. The EG group was engaged in the running-based exergame using Exer Heart and the TM group walked or jogged on a treadmill. Cardiorespiratory fitness (CRF), brachial artery flow-mediated dilation (FMD), endothelial progenitor cell numbers (EPCs), epicardial fat thickness (EFT), metabolic parameters and anthropometric parameters were measured in patients before and 3 months after the training.

Conditions

Aerobic Exercise; Cardiorespiratory Fitness; Cardiovascular Diseases

Keywords

Aerobic exercise; Exergame; cardiorespiratory fitness; endothelial function; epicardial fat

Outcome Measures

Primary Outcomes (1)

• Change of volume of maximal oxygen uptake

  maximal oxygen uptake refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity.

  Change from Baseline maximal oxygen uptake at 3 months

Secondary Outcomes (2)

• Change of percent of flow mediated dilation

  Change from Baseline flow mediated dilation at 3 months

• Change of thickness of epicardial adipose tissue

  Change from Baseline epicardial adipose tissue at 3 months

Study Arms (3)

exergame group

EXPERIMENTAL

The exergame group performed exercise using the Exer Heart device (D\&J Humancare, Seoul, South Korea), which consisted of a running/jumping board and a screen connected to the board. The exercise program "Alchemist's Treasure", a running-based exergame, moves the avatar according to the user's motions and was used for the exercise session. "Alchemist's Treasure" is a game in which the user listens to stimulating music, runs with the avatar, avoiding obstacles, and wins items using the front, back, left, and right sensors on the exercise board. The subject can control the speed of the avatar movement by adjusting the walking or running speed on the board. This study did not enforce exercise intensity in order to allow patients to enjoy the exergame. Thus, during the training period, the patients exercised at a self-selected pace for 40 minutes per day.

Behavioral: exergame

treadmill group

ACTIVE COMPARATOR

The treadmill group consisted of 40 minutes of walking or jogging at 60-80% of the heart rate (HR) reserve. The exercise intensity was determined using the Karvonen method target HR = \[Exercise Intensity × (HRmax - resting HR)\] + resting HR. The HR was recorded during each session using an HR monitor (Polar RS400sd; Madison Height, Michigan, USA). The control group was asked to maintain their regular physical activity level for 12 weeks.

Behavioral: treadmill exercise

control group

NO INTERVENTION

The control group was asked to maintain their regular physical activity level for 12 weeks.

Interventions

exergame BEHAVIORAL

Exergame is 'exercise + game'.

exergame group

treadmill exercise BEHAVIORAL

traditional aerobic exercise

treadmill group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Framingham CV disease 10-year risk score above 20%
• post-menopausal women
• no history of exercise

You may not qualify if:

• resistant hypertension
• liver disease
• neurologic disorders
• malignant disease
• chronic obstructive pulmonary disease
• valvular heart disease
• musculoskeletal patients

Sponsors & Collaborators

• Kyoung Im Cho: lead

Study Sites (1)

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Related Publications (1)

• Baranowski T, Abdelsamad D, Baranowski J, O'Connor TM, Thompson D, Barnett A, Cerin E, Chen TA. Impact of an active video game on healthy children's physical activity. Pediatrics. 2012 Mar;129(3):e636-42. doi: 10.1542/peds.2011-2050. Epub 2012 Feb 27.

  PMID: 22371457 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kyoung Im Cho, MD, PhD

  Kosin University Gospel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: exergame group, treadmill group and control group

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)