Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure
NCT ID: NCT05641662
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2022-05-16
2027-04-30
Brief Summary
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Participants will, on a background of standard guideline-directed medical therapy patients, be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.
Detailed Description
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Objective: To determine the effect of tailored exergaming for inactive patients with HF to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.
Study design: A pilot study and a multicentre, open-label 1:1 randomised clinical trial with 6 months follow-up.
Study population: Adult patients with symptomatic HF: n= 20 for the pilot study and n=600 for the main study
Intervention: On a background of standard guideline-directed medical therapy patients will be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.
Main study parameters/endpoints: Primary endpoint is sedentary time (actigraphy). Secondary outcomes are daily physical activity, submaximal exercise capacity, physical frailty, health-related quality of life.
This study will gain insight into the effects of using an exergame that is easily applicable and affordable. Given the vast growing target population of patients with HF worldwide, and the simplicity of the intervention, potentially millions of patients may benefit from the results of this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Exergame group
Patients will be introduced to the exergame and the exergame will be installed following a protocol either by the patients themselves or an instructor of the study.
Patients will be advised to exergame daily based on their activity monitor reading at baseline and based on their current activity level and preferences.
During the 3 months of active intervention patients will receive feedback on their activity level and data will also be shared with the coach who will use it to adapt the gaming advice. A clear exergaming goal will be set together by patient and coach. In the first month, they will receive weekly feedback on their performance based on the readings from the activity monitor and the reading from the exergame. In the rest of the active study team the frequency of the contact with the coach will be personalized.
Heart Farming
Heart Farming is a mobile game. which can be played indoors and outdoors and stimulates players to be physically active. The game is built around a theme (farming) and users are challenged to collect products by being active. The phone will register movements and convert them into points and fruits and vegetables. For the basic playing only 10 minutes walking a day with the game is possible and is rewarded. For players who want more challenge and level of trading products and collecting products in groups is added. The game is adaptable to different levels of mobility and players can invite others to play with them. Players can see their own game results, progression, and active time.
Control group
Patients will receive a protocol-based activity advice (one time) from the HF team (nurse, cardiologist and/or physiotherapist) that corresponds to the intervention group in terms of time and effort. Participants in the control group are encouraged to decrease their sedentary behaviour to the same extent as the intervention group, and if possible be physical active 30 minutes for 5 days a week.
No interventions assigned to this group
Interventions
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Heart Farming
Heart Farming is a mobile game. which can be played indoors and outdoors and stimulates players to be physically active. The game is built around a theme (farming) and users are challenged to collect products by being active. The phone will register movements and convert them into points and fruits and vegetables. For the basic playing only 10 minutes walking a day with the game is possible and is rewarded. For players who want more challenge and level of trading products and collecting products in groups is added. The game is adaptable to different levels of mobility and players can invite others to play with them. Players can see their own game results, progression, and active time.
Eligibility Criteria
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Inclusion Criteria
2. Clinically stable
3. Physically inactive
4. Older than 18 years, there is no upper age limit,
5. Speak/understand the language of the country where the study is taking place.
6. Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study)
Exclusion Criteria
2. Not being able to perform the 6-minute walk test.
3. Not being able or willing to wear an activity monitor.
4. Currently included in a rehabilitation program
5. Lack of willingness to play an exergame.
6. Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).
18 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Tiny Jaarsma
Professor
Principal Investigators
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Tiny Jaarsma, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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P. J. Safarik University
Norrköping, , Slovakia
Germans Trias i Pujol Hospital
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Xarxa Assistencial Universitaria
Manresa, , Spain
INCLIVA
Valencia, , Spain
Jönköping Hospital Rydhov
Jönköping, , Sweden
Kalmar Länssjukhuset
Kalmar, , Sweden
Linköping University Hospital
Linköping, , Sweden
Primary Health Care Centers Östergötland
Norrköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Beatriz Gonzalez Fernandez
Role: primary
Sílvia Ibáñez Caballero, MSc
Role: primary
Nuria Santaularia
Role: primary
Patricia Palau, PhD
Role: primary
Tiny Jaarsma
Role: primary
Tiny Jaarsma
Role: primary
Tiny Jaarsma
Role: primary
Leonie Klompstra, PhD
Role: primary
Related Links
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Study website
Other Identifiers
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DNR 2020-01109
Identifier Type: -
Identifier Source: org_study_id