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

ConditionCardiovascular Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLinkoeping University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Heart Farming
Other intervention
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.

Treatment groups

750 Participants

are divided into 2 treatment groups

Group A: Exergame groupExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Sedentary time

Sedentary time measured with activity monitor Actigraph

Time frame

3 months

Secondary outcomes

Exercise Capacity

6-minute walk test

Time frame

Baseline, 3 months and 6 months

Frailty

Fried Frailty tests

Time frame

Baseline, 3 months and 6 months

Clinical frailty

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

Time frame

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.

Time frame

Baseline, 3 months and 6 months

Other outcomes

Patient expectations

Open ended interview questions

Time frame

Baseline and 6 months

Exercise motivation

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.

Time frame

Baseline, 3 months and 6 months

Cost

Cost logbook

Time frame

6 months

Willingness to pay

Interviews

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linkoeping University

Lead sponsor

Source ClinicalTrials.gov

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