Clinical trial NCT05641662: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-12-08
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.
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).

Primary outcomes:
measure: Sedentary time
timeFrame: 3 months
Secondary outcomes:
measure: Exercise Capacity
timeFrame: Baseline, 3 months and 6 months
measure: Frailty
timeFrame: Baseline, 3 months and 6 months
measure: Clinical frailty
timeFrame: Baseline, 3 months and 6 months
measure: Heart Failure specific Quality of Life
timeFrame: Baseline, 3 months and 6 months
measure: General Quality of Life
timeFrame: Baseline, 3 months and 6 months
measure: Sedentary time
timeFrame: 6 months
Other outcomes:
measure: Patient expectations
timeFrame: Baseline and 6 months
measure: Exercise motivation
timeFrame: Baseline, 3 months and 6 months
measure: Cost
timeFrame: 6 months
measure: Willingness to pay
timeFrame: 6 months
measure: Time exergaming
timeFrame: During the 6 months intervention
measure: Enjoyment physical activity
timeFrame: 3 and 6 months in the intervention group only
measure: Cognitive function
timeFrame: Baseline, 3 months and 6 months
measure: Social and daily function
timeFrame: Baseline, 3 months and 6 months
measure: Depression
timeFrame: Baseline, 3 months and 6 months
measure: Self-care
timeFrame: Baseline, 3 months and 6 months
measure: Knowledge
timeFrame: Baseline
measure: Clinical Data
timeFrame: Baseline
measure: Adverse events
timeFrame: Throughout the trial of 6 months
Locations:
city: Norrköping
country: Slovakia
facility: P. J. Safarik University
city: Barcelona
country: Spain
facility: Germans Trias i Pujol Hospital
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Manresa
country: Spain
facility: Xarxa Assistencial Universitaria
city: Valencia
country: Spain
facility: INCLIVA
city: Jönköping
country: Sweden
facility: Jönköping Hospital Rydhov
city: Kalmar
country: Sweden
facility: Kalmar Länssjukhuset
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Norrköping
country: Sweden
facility: Primary Health Care Centers Östergötland
Study officials:
affiliation: Linkoeping University
name: Tiny Jaarsma, PhD
role: PRINCIPAL_INVESTIGATOR
References: