Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT01785121
• Lead Sponsor: Linkoeping University

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?

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 Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-07
• Study Start: 2013-09
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in 6 minute walk test	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

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

Trial Locations

Locations (10)

University of California; 🇺🇸 Irvine, California, United States

Center of Internal Medicine Elsterwerda; 🇩🇪 Elsterwerda, Germany

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Villa delle Querce hospital; 🇮🇹 Nemi, Italy

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

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