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

Официальное название

Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Sedentary time [Срок оценки: 3 months]

Вторичные конечные точки (6)

• Exercise Capacity [Срок оценки: Baseline, 3 months and 6 months]
• Frailty [Срок оценки: Baseline, 3 months and 6 months]
• Clinical frailty [Срок оценки: Baseline, 3 months and 6 months]
• Heart Failure specific Quality of Life [Срок оценки: Baseline, 3 months and 6 months]
• General Quality of Life [Срок оценки: Baseline, 3 months and 6 months]
• Sedentary time [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Испания · 5 центров

• Germans Trias i Pujol Hospital — Barcelona
• Hospital de Bellvitge — Barcelona
• Hospital del Mar — Barcelona
• Xarxa Assistencial Universitaria — Manresa
• INCLIVA — Valencia

Швеция · 5 центров

• Jönköping Hospital Rydhov — Jönköping
• Kalmar Länssjukhuset — Kalmar
• Linköping University Hospital — Linköping
• Primary Health Care Centers Östergötland — Norrköping
• Vrinnevisjukhuset — Norrköping

Португалия · 1 центр

• Universidade do Porto Faculdade de Medicina — Porto

Словакия · 1 центр

• P. J. Safarik University — Košice

Идентификаторы

NCT: NCT05641662 · DNR 2020-01109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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