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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: March 11, 2016
Last verified: March 2016

February 1, 2013
March 11, 2016
January 2013
January 2018   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01785121 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial

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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Motivational support only
  • 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
    Intervention: Behavioral: Structured access to a Wii game computer (Wii)
Jaarsma T, Klompstra L, Ben Gal T, Boyne J, Vellone E, Bäck M, Dickstein K, Fridlund B, Hoes A, Piepoli MF, Chialà O, Mårtensson J, Strömberg A. Increasing exercise capacity and quality of life of patients with heart failure through Wii gaming: the rationale, design and methodology of the HF-Wii study; a multicentre randomized controlled trial. Eur J Heart Fail. 2015 Jul;17(7):743-8. doi: 10.1002/ejhf.305.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Tiny Jaarsma +46 (0) 11363550 Tiny.Jaarsma@liu.se
Sweden
 
NCT01785121
HF-Wii
Yes
Not Provided
Not Provided
Tiny Jaarsma, Linkoeping University
Linkoeping University
  • The Swedish Research Council
  • Hälsohögskolan i Jönköping
Not Provided
Linkoeping University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP