Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure (Heart-eXg)

Linköping University (LiU)

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: Heart Farming

Study type: Interventional

Funder types: Other

Identifiers

NCT05641662

DNR 2020-01109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 2 patient groups

Exergame group

Experimental group

Description:

Patients will be introduced to the exergame and the exergame will be installed following a protocol either by the patients themselves or an instructor of the study. Patients will be advised to exergame daily based on their activity monitor reading at baseline and based on their current activity level and preferences. During the 3 months of active intervention patients will receive feedback on their activity level and data will also be shared with the coach who will use it to adapt the gaming advice. A clear exergaming goal will be set together by patient and coach. In the first month, they will receive weekly feedback on their performance based on the readings from the activity monitor and the reading from the exergame. In the rest of the active study team the frequency of the contact with the coach will be personalized.

Treatment:

Other: Heart Farming

Control group

No Intervention group

Description:

Patients will receive a protocol-based activity advice (one time) from the HF team (nurse, cardiologist and/or physiotherapist) that corresponds to the intervention group in terms of time and effort. Participants in the control group are encouraged to decrease their sedentary behaviour to the same extent as the intervention group, and if possible be physical active 30 minutes for 5 days a week.