Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

Heart Failure Clinical Trial

— HF-Wii  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785121
• Other study ID #: HF-Wii
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2019
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Linkoeping University	Medical Research Council of Southeast Sweden, Swedish Heart Lung Foundation, Swedish National Science Council/Swedish research council for health, working life and welfare, The Swedish Heart and Lung Association, The Swedish Research Council, Vardalinstitutet The Swedish Institute for Health Sciences

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Italy,  Netherlands,  Sweden, 

Outcome

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