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ClinicalTrials.gov ID

NCT05641662

Lead Sponsor

Linkoeping UniversityOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

750Estimated

Last Update Posted

Mar 10, 2026Actual

Start Date

May 16, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jul 30, 2027Estimated

Official Title

Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study

Brief Summary

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.

Detailed Description

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.

• Cardiovascular Diseases

• Heart Farming

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.
2. Clinically stable
3. Physically inactive
4. Older than 18 years, there is no upper age limit,
5. Speak/understand the language of the country where the study is taking place.
6. Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study)

Exclusion Criteria:

1. Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.
2. Not being able to perform the 6-minute walk test.
3. Not being able or willing to wear an activity monitor.
4. Currently included in a rehabilitation program
5. Lack of willingness to play an exergame.
6. Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Linkoeping UniversityOTHER_GOV

patripalau@gmail.com+34606380491