Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure

NCT05641662 | Recruiting

• 1 other identifier: DNR 2020-01109
• Study Type: interventional
• Target: 750
• Locations: 4 countries
• Sites: 12

Brief 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. 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Sedentary time

  Sedentary time measured with activity monitor Actigraph

  3 months

Secondary Outcomes (6)

• Exercise Capacity

  Baseline, 3 months and 6 months

• Frailty

  Baseline, 3 months and 6 months

• Clinical frailty

  Baseline, 3 months and 6 months

• Heart Failure specific Quality of Life

  Baseline, 3 months and 6 months

• General Quality of Life

  Baseline, 3 months and 6 months

Other Outcomes (13)

• Patient expectations

  Baseline and 6 months

• Exercise motivation

  Baseline, 3 months and 6 months

• Cost

  6 months

Study Arms (2)

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.

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.

Interventions

Heart Farming OTHER

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.

Exergame group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (12)

Universidade do Porto Faculdade de Medicina

Porto, Portugal

RECRUITING

P. J. Safarik University

Košice, Slovakia

RECRUITING

Germans Trias i Pujol Hospital

Barcelona, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

ACTIVE NOT RECRUITING

Xarxa Assistencial Universitaria

Manresa, Spain

RECRUITING

INCLIVA

Valencia, Spain

RECRUITING

Jönköping Hospital Rydhov

Jönköping, Sweden

RECRUITING

Kalmar Länssjukhuset

Kalmar, Sweden

TERMINATED

Linköping University Hospital

Linköping, Sweden

RECRUITING

Primary Health Care Centers Östergötland

Norrköping, 60591, Sweden

RECRUITING

Vrinnevisjukhuset

Norrköping, Sweden

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Tiny Jaarsma, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiny Jaarsma, PhD

CONTACT

+46011363550; tiny.jaarsma@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: December 8, 2022
• Study Start: May 16, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5); ES (5); SL (1); PT (1)