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NCT Number: NCT05641662

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Porto Faculdade de Medicina, Porto, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Sedentary time

    Time frame: 3 months

    Sedentary time measured with activity monitor Actigraph

Secondary outcomes

  1. Exercise Capacity

    Time frame: Baseline, 3 months and 6 months

    6-minute walk test

  2. Frailty

    Time frame: Baseline, 3 months and 6 months

    Fried Frailty tests

  3. Clinical frailty

    Time frame: Baseline, 3 months and 6 months

    Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill)

  4. Heart Failure specific Quality of Life

    Time frame: Baseline, 3 months and 6 months

    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.

  5. General Quality of Life

    Time frame: Baseline, 3 months and 6 months

    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

  6. Sedentary time

    Time frame: 6 months

    Sedentary time measured with activity monitor Actigraph

Other outcomes

  1. Patient expectations

    Time frame: Baseline and 6 months

    Open ended interview questions

  2. Exercise motivation

    Time frame: Baseline, 3 months and 6 months

    The situational motivation scale (SIMS): 16 items measuring four forms of motivation with exh four items (amotivation, external, identified, and intrinsic motivation). Each item is rated on a 7-point Likert scale ranging from 1 "corresponds not at all" to 7 "corresponds exactly." The score of each form of motivation ranges from 4-28, with a higher score meaning higher motivation.

  3. Cost

    Time frame: 6 months

    Cost logbook

  4. Willingness to pay

    Time frame: 6 months

    Interviews

  5. Time exergaming

    Time frame: During the 6 months intervention

    Record time exergaming

  6. Enjoyment physical activity

    Time frame: 3 and 6 months in the intervention group only

    Exergaming Enjoyment Scale, 20 items, scoring ranging from 20-100

  7. Cognitive function

    Time frame: Baseline, 3 months and 6 months

    Montreal Cognitive Assessment (MoCA)

  8. Social and daily function

    Time frame: Baseline, 3 months and 6 months

    Canadian Occupational Performance Measure (COPM)

  9. Depression

    Time frame: Baseline, 3 months and 6 months

    Hospital Anxiety and Depression scale( HADs): two conjoint 7-item subscales, one specifically targeted at anxiety (HADS-A) and one focussing on depression (HADS-D). Raw scores of between 8 and 10 identify mild cases of depression or anxiety, 11-15 moderate cases, and 16 or above, severe cases.

  10. Self-care

    Time frame: Baseline, 3 months and 6 months

    European Self-Care Behavioural Scale (ESCBS): nine statements about HF-specific self-care which have to be rated on a 5-point Likert scale ('completely agree' and 'I don't agree at all').The sum score of range from 9 to 45, with lower scores indicating better self-care.

  11. Knowledge

    Time frame: Baseline

    Heart Failure Knowledge Scale: 15-item, self-administered questionnaire that covers items concerning HF knowledge in general, knowledge on HF treatment (including diet and fluid restriction) and HF symptoms and symptom recognition. The scale has a minimum score of 0 (no knowledge) and a maximum score of 15 points (optimal knowledge).

  12. Clinical Data

    Time frame: Baseline

    Clinical data from patient journal

  13. Adverse events

    Time frame: Throughout the trial of 6 months

    Number of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Tiny Jaarsma, PhD

CONTACT

[email protected]

+46011363550

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study 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

Acronym: Heart-eXg

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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