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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Linkoeping University
Sponsor:
Collaborators:
The Swedish Research Council
Hälsohögskolan i Jönköping
Information provided by (Responsible Party):
Tiny Jaarsma, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01785121
First received: February 1, 2013
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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?

Condition Intervention
Heart Failure
Behavioral: Structured access to a Wii game computer (Wii)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • change in 6 minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Structured access to a Wii game computer (Wii)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785121

Contacts
Contact: Tiny Jaarsma +46 (0) 11363550 Tiny.Jaarsma@liu.se

Locations
Sweden
Vrinnevi Hospital Recruiting
Norrköping, Sweden
Contact: Tiny Jaarsma, PhD    +46 (0) 11363550    Tiny.Jaarsma@liu.se   
Contact: Anna Stromberg, PhD       anna.stromberg@liu.se   
Sub-Investigator: Leonie Verheijden Klompstra         
Sponsors and Collaborators
Linkoeping University
The Swedish Research Council
Hälsohögskolan i Jönköping
  More Information

No publications provided

Responsible Party: Tiny Jaarsma, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01785121     History of Changes
Other Study ID Numbers: HF-Wii
Study First Received: February 1, 2013
Last Updated: February 4, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014