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.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is sedentary time (actigraphy).
Secondary outcome
Secondary outcomes are daily physical activity, submaximal exercise capacity,
physical frailty, health-related quality of life.
Background summary
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.
Study 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 randomized clinical trial with
6 months follow-up.
Intervention
On a background of standard guideline-directed medical therapy patients will be
randomized to tailored activity advice (control) or the Heart-Exergame
(Heart-eXg) intervention for a period of 3 months. Patients randomized 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 or to play virtually with a volunteer.
Study burden and risks
Study participants (patients with HF) will be recruited and treated according
to standard clinical practice. They will be randomized for 3 months to a
tailored activity advice or the gaming intervention. At baseline, after 3 and 6
months, participants will be asked to fill out questionnaires, perform a
6-minute walk test, a cognition test, and a frailty test. In addition, all
patients will be asked to wear an activity monitor for two weeks before
baseline randomisation and after 3 and 6 months.
In terms of benefits and risks, physical activity is important for patients
with HF. 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. Risk is estimated as very low, since activity level and format are
adapted to the patient*s capacity.
Linkoping 1
Linkoping 58983
NL
Linkoping 1
Linkoping 58983
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosed with symptomatic Heart Failure (NYHA II-IV) as diagnosed by
cardiologist, (independent of Ejection Fraction)
2. Clinically stable
3. Physically inactive by self-report
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 a member of the local study team, e.g. cardiologist,
physiotherapist, nurse.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05641662 |
| CCMO | NL84156.042.23 |