The overall purpose of the study is to determine the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure (HF) to improve their exercise capacity, their daily physical activity, decrease health…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exercise capacity measured by 6 minute walking test
Secondary outcome
Daily physical activity, muscle function, exercise motivation, self-efficacy
beliefs, perceived physical effort, heart failure symptoms, health related
quality of life mortality, global well-being, number of readmissions,
mortality, costs and patient experiences.
Background summary
Heart failure (HF) is highly prevalent, the estimate total prevalence of heart
failure worldwide is 1-2 % The number of HF patients is increasing, due to the
aging of the population and the therapeutic advantages which improve survival
in patients An increasing number of HF patients is living longer in the
community. As part of the treatment in HF, patients are advised to be or become
more physically active, because exercise in HF is related to improved outcomes
such as decreased symptoms, improved survival and better quality of life . A
meta-analysis including 801 patients who had been randomized in trials of
exercise training found that patients randomized to training were less often
admitted to hospital and had a better prognosis . The most recent study on
training in HF patients was the HF-ACTION (Heart Failure: A Controlled Trial
Investigating Outcomes of Exercise Training) In this study HF patients who
trained in a hospital and home based program improved exercise capacity and had
a significant benefit in all-cause mortality.
However, despite positive outcomes of the effects of exercise, adherence to
exercise in HF patients is low (around 50%) and non-adherence to
recommendations has a negative effect on clinical outcome such as HF
readmission and mortality . Also, the main limitation in the HF-ACTION was the
poor adherence to the prescribed training regimen (only 30% after 3 years) and
in the COACH study, only 39% of patients reported to be adherent with exercise
recommendations, despite the fact that 80% of them recognized its importance .
Barriers to being and staying active are often related to motivation and
practical issues, such as time, possibility to travel to an exercise or
rehabilitation center or costs.
Activity in the home is increasingly studied, by for example introducing
walking programs or exercise programs in primary care. Becoming physically
active is a first step to get to an excise level to improve outcomes. However,
it is not easy to stay motivated and in addition, climates (e.g. cold weather
in countries like Sweden or heat in countries like Italy, Australia and Israel)
can make it difficult for patients to leave their homes to engage in exercise
activities.
*
A new approach to increase physical activity at home is the use of *serious
virtual reality games*. The use of so-called *serious gaming* are recognized to
have much to offer to the fields of prevention and rehabilitation . On the
other hand, to avoid a new *hype* overestimating the potentials of these games,
these new options should be tested in specific groups of patients.
In a pilot study a promising potential of increasing exercise capacity was
seen by introducing a selected group of HF patients to the Wii game computer.
However, to test the effectiveness of this intervention a larger randomized
study is needed.
Study objective
The overall purpose of the study is to determine the effectiveness of
structured introduction and access to a Wii game computer in patients with
heart failure (HF) to improve their exercise capacity, their daily physical
activity, decrease health care use and improve quality of life.
Study design
A multicentre randomised controlled design with 2 treatment groups/conditions.
In each centre, patients will be randomised into one of these conditions:
motivational support only (CONTROL) or structured access to a Wii game computer
(Wii).
Intervention
Two types of interventions will be tested. All patients receive usual treatment
and care. Patients in the Control group will receive an advice on activity and
4 telephone calls. Patients in the Wii group will receive an advice on
activity, 4 telephone calls and a Wii game computer.
Study burden and risks
No extra risk associated with participation.Burden to patient due to
questionnaires.
Following daily advice regarding physical activity is not an extra burden,
but is similar to usual physical activity advice
institutionen for samhalls- och valfradssuddier LIU 1
Norrkoping 601 74
SE
institutionen for samhalls- och valfradssuddier LIU 1
Norrkoping 601 74
SE
Listed location countries
Age
Inclusion criteria
heart failure ( Nyha I-V)
> 18 jears
Speaking and understanding Dutch language
Exclusion criteria
patient is unable to use the Nintendo WII due to visual, cognitive or motor impairment
life expectancy shorter than 6 months
The patient is already playing a WII at home
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 |
---|---|
CCMO | NL48647.068.14 |