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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Structured access to a Wii game computer (Wii)
Motivational support only
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California
  • Center of Internal Medicine Elsterwerda
  • Rabin Medical Center
  • Villa delle Querce hospital
  • Maastricht University Medical Center
  • Länssjukhuset Ryhov hospital
  • University hospital Linköping
  • Vrinnevi Hospital
  • Nyköpings lasarett hospital
  • Karolinska University Hospital Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Wii Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2013
Last Updated
April 2, 2019
Sponsor
Linkoeping University
Collaborators
The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation, Vardalinstitutet The Swedish Institute for Health Sciences, Medical Research Council of Southeast Sweden, Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT01785121
Brief Title
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming
Acronym
HF-Wii
Official Title
Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii) A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
The Swedish Research Council, The Swedish Heart and Lung Association, Swedish Heart Lung Foundation, Vardalinstitutet The Swedish Institute for Health Sciences, Medical Research Council of Southeast Sweden, Swedish Council for Working Life and Social Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wii Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Structured access to a Wii game computer (Wii)
Other Intervention Name(s)
Wii group
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational support only
Other Intervention Name(s)
MOS
Intervention Description
The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks
Primary Outcome Measure Information:
Title
change in 6 minute walk test
Description
The 6 minute walk test measures the amount of meters covered by a patients in 6 minutes using a protocolled assessment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Muscle function
Description
assessed with bilateral isometric shoulder abduction and unilateral isotonic shoulder flexion using predefined protocols
Time Frame
Baseline, 3, 6, 12 months
Title
Exercise Motivation
Description
assessed by the Exercise motivation Index (EMI)
Time Frame
Baseline, 3, 6, 12 months
Title
Daily Physical Activity
Description
measured by an activity monitor
Time Frame
monitored every day during 6 months
Title
Exercise Self-Efficacy
Description
assessed by the exercise self-efficacy questionnaire (SEE)
Time Frame
Baseline, 3, 6, 12 months
Title
Perceived Physical Effort
Description
assessed with the Borg's scale of perceived exertion
Time Frame
Daily for the first 3 months
Title
Heart Failure Symptoms
Description
assessed using a 10 point VAS scale
Time Frame
Daily for the first 3 months
Title
Health Related Quality of Life
Description
assessed with Minnesota Living with Heart Failure Questionnaire(MLWHFQ)
Time Frame
Baseline, 3, 6, 12 months
Title
Global Well-Being
Description
assessed with Cantril's ladder of life
Time Frame
Daily for the first 3 months
Title
Readmission
Description
assessed from the medical record
Time Frame
12 months
Title
Costs
Description
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
Time Frame
12 months
Title
Experiences of patients
Description
An open ended survey will be used to collect data on patient's experiences and challenges
Time Frame
12 months
Title
change in 6 minute walk
Time Frame
6 and 12 monhts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of California
City
Irvine
State/Province
California
ZIP/Postal Code
CA 92697
Country
United States
Facility Name
Center of Internal Medicine Elsterwerda
City
Elsterwerda
Country
Germany
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Villa delle Querce hospital
City
Nemi
Country
Italy
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
Länssjukhuset Ryhov hospital
City
Jönköping
Country
Sweden
Facility Name
University hospital Linköping
City
Linköping
Country
Sweden
Facility Name
Vrinnevi Hospital
City
Norrköping
Country
Sweden
Facility Name
Nyköpings lasarett hospital
City
Nyköping
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32501275
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.
Results Reference
derived
PubMed Identifier
32167657
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.
Results Reference
derived
PubMed Identifier
26139585
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.
Results Reference
derived

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Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming

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