Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT05641662
- Lead Sponsor
- Linkoeping University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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
- 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)
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sedentary time 3 months Sedentary time measured with activity monitor Actigraph
- Secondary Outcome Measures
Name Time Method Clinical frailty Baseline, 3 months and 6 months Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill)
Exercise Capacity Baseline, 3 months and 6 months 6-minute walk test
Frailty Baseline, 3 months and 6 months Fried Frailty tests
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
Trial Locations
- Locations (10)
P. J. Safarik University
🇸🇰Norrköping, Slovakia
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
INCLIVA
🇪🇸Valencia, Spain
Primary Health Care Centers Östergötland
🇸🇪Norrköping, Sweden
Germans Trias i Pujol Hospital
🇪🇸Barcelona, Spain
Xarxa Assistencial Universitaria
🇪🇸Manresa, Spain
Jönköping Hospital Rydhov
🇸🇪Jönköping, Sweden
Kalmar Länssjukhuset
🇸🇪Kalmar, Sweden
Linköping University Hospital
🇸🇪Linköping, Sweden
P. J. Safarik University🇸🇰Norrköping, Slovakia