Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii)

• Muscle function [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
  assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols
• Exercise Motivation [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
  assessed by the Exercise motivation Index (EMI)
• Daily Physical Activity [ Time Frame: monitored every day during 6 months ] [ Designated as safety issue: No ]
  measured by an activity monitor
• Exercise Self-Efficacy [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
  assessed by the exercise self-efficacy questionnaire (SEE)
• Perceived Physical Effort [ Time Frame: Daily for the first 3 months ] [ Designated as safety issue: No ]
  assessed with the Borg's scale of perceived exertion
• Heart Failure Symptoms [ Time Frame: Daily for the first 3 months ] [ Designated as safety issue: No ]
  assessed using a 10 point VAS scale
• Health Related Quality of Life [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
  assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)
• Global Well-Being [ Time Frame: Daily for the first 3 months ] [ Designated as safety issue: No ]
  assessed with Cantril's ladder of life
• Readmission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  assessed from the medical record
• Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  cost of readmission, bed days occupancy (all cause) in medical/surgical beds, home care, contacts with and interventions of primary care, cost of the intervention (Wii game computer, instruction session etc.) and developing the intervention, materials and laboratory tests used
• Experiences of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  An open ended survey will be used to collect data on patient's experiences and challenges
• change in 6 minute walk [ Time Frame: 6 and 12 monhts ] [ Designated as safety issue: No ]

The study objectives are to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. Secondly, to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life.

The following research questions will be addressed:

• What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure to improve their exercise capacity compared to patients with heart failure in a control group who only receive motivational support?
• What is the effectiveness of structured introduction and access to a Wii game computer in patients with heart failure compared to patients with heart failure in a control group who only receive motivational support to increase their daily physical activity, decrease health care use and improve quality of life?
• What are experiences of heart failure patients and how is their exercise motivation when they are introduced and instructed to play with a Wii game computer?

• Placebo Comparator: Motivational support only (MSO)
  Patients who are randomized to the MSO group will get a protocoled exercise advice from a member of the HF team (nurse, cardiologist or physiotherapist). During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their current activity.
• Experimental: Structured access to a Wii game computer (Wii)
  Patients who are randomized to the Wii group will be introduced to the Nintendo Wii game computer in an introduction lesson of approximately two hours and the Wii will be installed at home. During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their experiences with the Wii or to solve possible problems
  Intervention: Behavioral: Structured access to a Wii game computer (Wii)

Inclusion Criteria:

• Diagnosed with HF (NYHA I-IV) (independent of Ejection Fraction: both patients with a preserved ejection fraction (HFPEF) or reduced ejection fraction (HFREF) can be included)
• Older than 18 years, there is no upper age limit
• Speak/understand the language of the country where the intervention is taken place

Exclusion Criteria:

• The patient is expected to be unable to use the Nintendo Wii due to visual (see a TV screen at a distance of 3 m) cognitive (assessed by the HF nurse or cardiologist) or motor impairment (the patient should be able to swing his arm at least 10 times in a row)
• The patient has restrictions that would them unable patients to fill in data collection material
• The patient has a life expectancy shorter than 6 months

• The Swedish Research Council
• Hälsohögskolan i Jönköping