Clinical trial NCT01785121: Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming
Official title: Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Research Council
name: The Swedish Heart and Lung Association
name: Swedish Heart Lung Foundation
name: Vardalinstitutet The Swedish Institute for Health Sciences
name: Medical Research Council of Southeast Sweden
name: Swedish Council for Working Life and Social Research
First posted: 2013-02-07
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change in 6 minute walk test
timeFrame: 3 months
Secondary outcomes:
measure: Muscle function
timeFrame: Baseline, 3, 6, 12 months
measure: Exercise Motivation
timeFrame: Baseline, 3, 6, 12 months
measure: Daily Physical Activity
timeFrame: monitored every day during 6 months
measure: Exercise Self-Efficacy
timeFrame: Baseline, 3, 6, 12 months
measure: Perceived Physical Effort
timeFrame: Daily for the first 3 months
measure: Heart Failure Symptoms
timeFrame: Daily for the first 3 months
measure: Health Related Quality of Life
timeFrame: Baseline, 3, 6, 12 months
measure: Global Well-Being
timeFrame: Daily for the first 3 months
measure: Readmission
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
measure: Experiences of patients
timeFrame: 12 months
measure: change in 6 minute walk
timeFrame: 6 and 12 monhts
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: Elsterwerda
country: Germany
facility: Center of Internal Medicine Elsterwerda
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Nemi
country: Italy
facility: Villa delle Querce hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov hospital
city: Linköping
country: Sweden
facility: University hospital Linköping
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Nyköping
country: Sweden
facility: Nyköpings lasarett hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.