Skip to main content
OpenTrials
Completed

NCT Number: NCT01785121

Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Internal Medicine Elsterwerda, Elsterwerda, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured access to a Wii game computer (Wii)

Behavioral

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

Motivational support only

Behavioral

The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks

Other names: MOS

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Medical Research Council of Southeast Sweden
  • Swedish Council for Working Life and Social Research
  • Swedish Heart Lung Foundation
  • The Swedish Heart and Lung Association
  • The Swedish Research Council
  • Vardalinstitutet The Swedish Institute for Health Sciences

Registry information

Official study title

Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial

Acronym: HF-Wii

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2013
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.