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Trial record 1 of 1 for:    HF-Wii
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Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785121
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
The Swedish Research Council
The Swedish Heart and Lung Association
Swedish Heart Lung Foundation
Vardalinstitutet The Swedish Institute for Health Sciences
Medical Research Council of Southeast Sweden
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Tiny Jaarsma, Linkoeping University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Heart Failure Behavioral: Structured access to a Wii game computer (Wii) Behavioral: Motivational support only Not Applicable

Detailed Description:

Substudy

HF-WII PLUS MEDIYOGA

In this substudy Medical Yoga will be tested in a randomized group next to the Wii and the control group in the HF-Wii study and therefore the substudy will be called HF-Wii plus MediYoga.

In addition to the usual treatment and information about rehabilitation and daily activities for heart failure patients, this group will train a 60-minute yoga class twice a week. Patients will sit on chairs or yoga mats to perform yoga. Each patient will perform a total of 20-24 sessions over a 12-weeks period. A session will include 10 min warm-up and breathing exercises, 40 minutes of yoga postures and finally 10 min relaxation and meditation. At the end of each session, participants have the opportunity to discuss their experiences or questions. At the first visit, participants will receive a CD and a booklet with yoga postures and instructions. Patients are encouraged to train Medi Yoga at home with a target of one session a day. All yoga sessions will be conducted by a certified Medicare Yoga instructor.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date : September 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group
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.
 Behavioral: Motivational support only
The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks
Other Name: MOS
Experimental: Wii Group
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)
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
Other Name: Wii group


Outcome Measures
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Primary Outcome Measures :
  1. change in 6 minute walk test [ Time Frame: 3 months ]
    The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment


Secondary Outcome Measures :
  1. Muscle function [ Time Frame: Baseline, 3, 6, 12 months ]
    assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols

  2. Exercise Motivation [ Time Frame: Baseline, 3, 6, 12 months ]
    assessed by the Exercise motivation Index (EMI)

  3. Daily Physical Activity [ Time Frame: monitored every day during 6 months ]
    measured by an activity monitor

  4. Exercise Self-Efficacy [ Time Frame: Baseline, 3, 6, 12 months ]
    assessed by the exercise self-efficacy questionnaire (SEE)

  5. Perceived Physical Effort [ Time Frame: Daily for the first 3 months ]
    assessed with the Borg's scale of perceived exertion

  6. Heart Failure Symptoms [ Time Frame: Daily for the first 3 months ]
    assessed using a 10 point VAS scale

  7. Health Related Quality of Life [ Time Frame: Baseline, 3, 6, 12 months ]
    assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)

  8. Global Well-Being [ Time Frame: Daily for the first 3 months ]
    assessed with Cantril's ladder of life

  9. Readmission [ Time Frame: 12 months ]
    assessed from the medical record

  10. Costs [ Time Frame: 12 months ]
    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

  11. Experiences of patients [ Time Frame: 12 months ]
    An open ended survey will be used to collect data on patient's experiences and challenges

  12. change in 6 minute walk [ Time Frame: 6 and 12 monhts ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785121


Locations
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United States, California
University of California
Irvine, California, United States, CA 92697
Germany
Center of Internal Medicine Elsterwerda
Elsterwerda, Germany
Israel
Rabin Medical Center
Petah Tikva, Israel
Italy
Villa delle Querce hospital
Nemi, Italy
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sweden
Länssjukhuset Ryhov hospital
Jönköping, Sweden
University hospital Linköping
Linköping, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Nyköpings lasarett hospital
Nyköping, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Sponsors and Collaborators
Linkoeping University
The Swedish Research Council
The Swedish Heart and Lung Association
Swedish Heart Lung Foundation
Vardalinstitutet The Swedish Institute for Health Sciences
Medical Research Council of Southeast Sweden
Swedish Council for Working Life and Social Research
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tiny Jaarsma, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01785121    
Other Study ID Numbers: HF-Wii
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases