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

Cardiovascular Diseases Clinical Trial

— Heart-eXg  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641662
• Other study ID #: DNR 2020-01109
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: December 2023
• Source: Linkoeping University
• Contact: Tiny Jaarsma, PhD
• Phone: +46011363550
• Email: tiny.jaarsma[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: April 30, 2027
• Est. primary completion date: August 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 by self-report * (see 6.3.1)

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Intervention

Other:
• Heart Farming
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.

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Barcelona
Spain	Xarxa Assistencial Universitaria	Manresa
Sweden	Jönköping Hospital Rydhov	Jönköping
Sweden	Kalmar Länssjukhuset	Kalmar
Sweden	Linköping University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Countries where clinical trial is conducted

Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient expectations	Open ended interview questions	Baseline and 6 months
Other	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.	Baseline, 3 months and 6 months
Other	Cost	Cost logbook	6 months
Other	Willingness to pay	Interviews	6 months
Other	Time exergaming	Record time exergaming	During the 6 months intervention
Other	Enjoyment physical activity	Exergaming Enjoyment Scale, 20 items, scoring ranging from 20-100	3 and 6 months in the intervention group only
Other	Cognitive function	Montreal Cognitive Assessment (MoCA)	Baseline, 3 months and 6 months
Other	Social and daily function	Canadian Occupational Performance Measure (COPM)	Baseline, 3 months and 6 months
Other	Depression	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.	Baseline, 3 months and 6 months
Other	Self-care	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.	Baseline, 3 months and 6 months
Other	Knowledge	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).	Baseline
Other	Clinical Data	Clinical data from patient journal	Baseline
Other	Adverse events	Number of adverse events	Throughout the trial of 6 months
Primary	Sedentary time	Sedentary time measured with activity monitor Actigraph	3 months
Secondary	Exercise Capacity	6-minute walk test	Baseline, 3 months and 6 months
Secondary	Frailty	Fried Frailty tests	Baseline, 3 months and 6 months
Secondary	Clinical frailty	Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill)	Baseline, 3 months and 6 months
Secondary	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.	Baseline, 3 months and 6 months
Secondary	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	Baseline, 3 months and 6 months
Secondary	Sedentary time	Sedentary time measured with activity monitor Actigraph	6 months

External Links

•   Study website