Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Heart Farming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Clinically stable Physically inactive by self-report * (see 6.3.1) Older than 18 years, there is no upper age limit, Speak/understand the language of the country where the study is taking place. 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: Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist. Not being able to perform the 6-minute walk test. Not being able or willing to wear an activity monitor. Currently included in a rehabilitation program Lack of willingness to play an exergame. Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergame group<br>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. | Other: Heart Farming<br>* Heart Farming is a mobile game. which can be played indoors and outdoors and stimulates players to be physically active. The game is built around a theme (farming) and users are challenged to collect products by being active. The phone will register movements and convert them into points and fruits and vegetables. For the basic playing only 10 minutes walking a day with the game is possible and is rewarded. For players who want more challenge and level of trading products and collecting products in groups is added. The game is adaptable to different levels of mobility and players can invite others to play with them. Players can see their own game results, progression, and active time.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary time | Sedentary time measured with activity monitor Actigraph | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity | 6-minute walk test | Baseline, 3 months and 6 months | 
| Frailty | Fried Frailty tests | Baseline, 3 months and 6 months | 
| Clinical frailty | Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill) | Baseline, 3 months and 6 months | 
| Heart Failure specific Quality of Life | 12 item Kansas City Cardiomyopathy includes that quantifies physical limitations, symptom frequency, Quality of Life, and social limitation, along with a summary scores for each domain, scoring from 0 to 100. Zero denoting the worst and 100 the best possible health status. | Baseline, 3 months and 6 months | 
| General Quality of Life | EuroQol-5 Dimension 5 levels (EQ-5D) includes five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain. A higher score in the EQ-5D-5L indicated better HRQOL | Baseline, 3 months and 6 months | 
| Sedentary time | Sedentary time measured with activity monitor Actigraph | 6 months |