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

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?

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Motivational support only; Behavioral: Structured access to a Wii game computer (Wii)

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 Type: Interventional
• Enrollment (Actual): 605
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Elsterwerda, Germany
    • Center of Internal Medicine Elsterwerda
• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center
• Italy
  • Nemi, Italy
    • Villa delle Querce hospital
• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center
• Sweden
  • Jönköping, Sweden
    • Länssjukhuset Ryhov hospital
  • Linköping, Sweden
    • University Hospital Linköping
  • Norrköping, Sweden
    • Vrinnevi Hospital
  • Nyköping, Sweden
    • Nyköpings lasarett hospital
  • Stockholm, Sweden
    • Karolinska University Hospital Huddinge
• United States
  • California
    • Irvine, California, United States, CA 92697
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Wii group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 6 minute walk test	The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle function	assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols	Baseline, 3, 6, 12 months
Exercise Motivation	assessed by the Exercise motivation Index (EMI)	Baseline, 3, 6, 12 months
Daily Physical Activity	measured by an activity monitor	monitored every day during 6 months
Exercise Self-Efficacy	assessed by the exercise self-efficacy questionnaire (SEE)	Baseline, 3, 6, 12 months
Perceived Physical Effort	assessed with the Borg's scale of perceived exertion	Daily for the first 3 months
Heart Failure Symptoms	assessed using a 10 point VAS scale	Daily for the first 3 months
Health Related Quality of Life	assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)	Baseline, 3, 6, 12 months
Global Well-Being	assessed with Cantril's ladder of life	Daily for the first 3 months
Readmission	assessed from the medical record	12 months
Costs	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	12 months
Experiences of patients	An open ended survey will be used to collect data on patient's experiences and challenges	12 months
change in 6 minute walk		6 and 12 monhts

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: The Swedish Research Council; Swedish Council for Working Life and Social Research; Swedish Heart Lung Foundation; Medical Research Council of Southeast Sweden; The Swedish Heart and Lung Association; Vardalinstitutet The Swedish Institute for Health Sciences

Publications and helpful links

General Publications

• Poli A, Kelfve S, Klompstra L, Stromberg A, Jaarsma T, Motel-Klingebiel A. Prediction of (Non)Participation of Older People in Digital Health Research: Exergame Intervention Study. J Med Internet Res. 2020 Jun 5;22(6):e17884. doi: 10.2196/17884.
• Jaarsma T, Klompstra L, Ben Gal T, Ben Avraham B, Boyne J, Back M, Chiala O, Dickstein K, Evangelista L, Hagenow A, Hoes AW, Hagglund E, Piepoli MF, Vellone E, Zuithoff NPA, Martensson J, Stromberg A. Effects of exergaming on exercise capacity in patients with heart failure: results of an international multicentre randomized controlled trial. Eur J Heart Fail. 2021 Jan;23(1):114-124. doi: 10.1002/ejhf.1754. Epub 2020 Mar 13.
• Jaarsma T, Klompstra L, Ben Gal T, Boyne J, Vellone E, Back M, Dickstein K, Fridlund B, Hoes A, Piepoli MF, Chiala O, Martensson J, Stromberg 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF-Wii