Cardiovascular DiseasesHeart-eXgNCT05641662
Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure
A study testing Heart Farming in people with Cardiovascular Diseases, run by Linkoeping University at 12 sites in 4 countries.
Trial summary
The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Heart Farming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 16 May 2022to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.
- Clinically stable
- Physically inactive
- Older than 18 years, there is no upper age limit,
- Speak/understand the language of the country where the study is taking place.
- 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)
Who cannot join
- Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.
- Not being able to perform the 6-minute walk test.
- Not being able or willing to wear an activity monitor.
- Currently included in a rehabilitation program
- Lack of willingness to play an exergame.
- Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 4 countries
Spain5 sites, 4 recruiting
- Recruiting
Germans Trias i Pujol Hospital
Barcelona
Beatriz Gonzalez Fernandez, +46700896360, heartexg@hmv.liu.se
- Recruiting
Hospital de Bellvitge
Barcelona
Sílvia Ibáñez Caballero, MSc, +34606380491, sibanez@bellvitgehospital.cat
- Active, not recruiting
Hospital del Mar
Barcelona
- Recruiting
Xarxa Assistencial Universitaria
Manresa
Nuria Santaularia, +46700896360, heartexg@hmv.liu.se
- Recruiting
INCLIVA
Valencia
Patricia Palau, PhD, +34606380491, patripalau@gmail.com
Sweden5 sites, 4 recruiting
- Recruiting
Jönköping Hospital Rydhov
Jönköping
Tiny Jaarsma
- Terminated
Kalmar Länssjukhuset
Kalmar
- Recruiting
Linköping University Hospital
Linköping
Tiny Jaarsma
- Recruiting
Primary Health Care Centers Östergötland
Norrköping, 60591
Leonie Klompstra, PhD, +46700896360, heartexg@hmv.liu.se
- Recruiting
Vrinnevisjukhuset
Norrköping
Laila Hübbert, PhD, +46700896360, heartexg@hmv.liu.se
Portugal1 site, 1 recruiting
- Recruiting
Universidade do Porto Faculdade de Medicina
Porto
Bruno Delgado, PhD, +46700896360, heartexg@hmv.liu.se
Slovakia1 site, 1 recruiting
- Recruiting
P. J. Safarik University
Košice
Aurel Zelko, PhD, +46700896360, aurel.zelko@upjs.sk
About this study
Official title: Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study
The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.
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.
Read the detailed description
Rationale: Heart failure (HF) is an increasing global health concern with over 20 million patients worldwide. A decrease in sedentary time can have beneficial effects for a growing group of inactive patients with HF. The use of exergames (games to improve physical activity) is promising for people who are home bound and physically inactive. Such a gaming activity should be attractive, tailored to preferences and to capacity.
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
- Cardiovascular Diseases
- Being tested
- Heart Farming
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart FarmingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame group | Experimental | 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. Receives: Other: Heart Farming |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary time
Sedentary time measured with activity monitor Actigraph
Measured: 3 months
Secondary outcomes (6)
Exercise Capacity
6-minute walk test
Measured: Baseline, 3 months and 6 months
Frailty
Fried Frailty tests
Measured: Baseline, 3 months and 6 months
Clinical frailty
Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill)
Measured: Baseline, 3 months and 6 months
Heart Failure specific Quality of Life
12 item Kansas City Cardiomyopathy includes that quantifies physical limitations, symptom frequency, Quality of Life, and social limitation, along with a summary scores for each domain, scoring from 0 to 100. Zero denoting the worst and 100 the best possible health status.
Measured: Baseline, 3 months and 6 months
General Quality of Life
EuroQol-5 Dimension 5 levels (EQ-5D) includes five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain. A higher score in the EQ-5D-5L indicated better HRQOL
Measured: Baseline, 3 months and 6 months
Sedentary time
Sedentary time measured with activity monitor Actigraph
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start16 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tiny Jaarsma, Linkoeping University
- Investigators
- Tiny Jaarsma, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641662
- Sponsor's protocol ID
- DNR 2020-01109
- Acronym
- Heart-eXg
- Status last verified
- Feb 2026
- First submitted
- 17 May 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study
- ClinicalTrials.gov ID
- NCT05641662
- Acronym / sponsor ID
- Heart-eXg / DNR 2020-01109
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.
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
Rationale: Heart failure (HF) is an increasing global health concern with over 20 million patients worldwide. A decrease in sedentary time can have beneficial effects for a growing group of inactive patients with HF. The use of exergames (games to improve physical activity) is promising for people who are home bound and physically inactive. Such a gaming activity should be attractive, tailored to preferences and to capacity.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame group | Experimental | Other: Heart FarmingPatients 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.
- Clinically stable
- Physically inactive
- Older than 18 years, there is no upper age limit,
- Speak/understand the language of the country where the study is taking place.
Key exclusion criteria (6 listed)
- Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.
- Not being able to perform the 6-minute walk test.
- Not being able or willing to wear an activity monitor.
- Currently included in a rehabilitation program
- Lack of willingness to play an exergame.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart FarmingHeart 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. | Other | Exergame group |
Primary outcome
Sedentary time
Time frame: 3 months
Sedentary time measured with activity monitor Actigraph
6 secondary outcomes
Exercise Capacity
Time frame: Baseline, 3 months and 6 months
Frailty
Time frame: Baseline, 3 months and 6 months
Clinical frailty
Time frame: Baseline, 3 months and 6 months
Heart Failure specific Quality of Life
Time frame: Baseline, 3 months and 6 months
General Quality of Life
Time frame: Baseline, 3 months and 6 months
Sedentary time
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiny Jaarsma, PhD principal investigator
Linkoeping University
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Farming in people with Cardiovascular Diseases, run by Linkoeping University at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Sweden, Portugal, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiny Jaarsma, PhD (+46011363550, tiny.jaarsma@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.