Cardiovascular Diseases
Conditions
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.
Interventions
OTHERHeart Farming
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.
Sponsors
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary time | 3 months | Sedentary time measured with activity monitor Actigraph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | Baseline, 3 months and 6 months | 6-minute walk test |
| Frailty | Baseline, 3 months and 6 months | Fried Frailty tests |
| Clinical frailty | Baseline, 3 months and 6 months | Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill) |
| Heart Failure specific Quality of Life | Baseline, 3 months and 6 months | 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. |
| General Quality of Life | Baseline, 3 months and 6 months | 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 |
| Sedentary time | 6 months | Sedentary time measured with activity monitor Actigraph |
Countries
Portugal, Slovakia, Spain, Sweden
Contacts
CONTACTTiny Jaarsma, PhD
PRINCIPAL_INVESTIGATORTiny Jaarsma, PhD
Linkoeping University
Outcome results
None listed