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Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study
The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life. Participants will, on a background of standard guideline-directed medical therapy patients, be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.
Rationale: Heart failure (HF) is an increasing global health concern with over 20 million patients worldwide. A decrease in sedentary time can have beneficial effects for a growing group of inactive patients with HF. The use of exergames (games to improve physical activity) is promising for people who are home bound and physically inactive. Such a gaming activity should be attractive, tailored to preferences and to capacity. Objective: To determine the effect of tailored exergaming for inactive patients with HF to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life. Study design: A pilot study and a multicentre, open-label 1:1 randomised clinical trial with 6 months follow-up. Study population: Adult patients with symptomatic HF: n= 20 for the pilot study and n=600 for the main study Intervention: On a background of standard guideline-directed medical therapy patients will be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network. Main study parameters/endpoints: Primary endpoint is sedentary time (actigraphy). Secondary outcomes are daily physical activity, submaximal exercise capacity, physical frailty, health-related quality of life. This study will gain insight into the effects of using an exergame that is easily applicable and affordable. Given the vast growing target population of patients with HF worldwide, and the simplicity of the intervention, potentially millions of patients may benefit from the results of this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universidade do Porto Faculdade de Medicina
Porto, Portugal
P. J. Safarik University
Košice, Slovakia
Germans Trias i Pujol Hospital
Barcelona, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Xarxa Assistencial Universitaria
Manresa, Spain
INCLIVA
Valencia, Spain
Jönköping Hospital Rydhov
Jönköping, Sweden
Kalmar Länssjukhuset
Kalmar, Sweden
Linköping University Hospital
Linköping, Sweden
Start Date
May 16, 2022
Primary Completion Date
December 31, 2026
Completion Date
July 30, 2027
Last Updated
March 10, 2026
750
ESTIMATED participants
Heart Farming
OTHER
Lead Sponsor
Linkoeping University
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06189313