Clinical trial NCT04633590: Home-Based Exercise Gaming for Physically Inactive Individuals
Official title: Effects of Home-based Exercise Gaming on Cardio-Metabolic and Cognitive Health Markers in Physically Inactive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: Home-based exercise gaming
Cardiovascular health
Neurocognitive health
Physical Inactivity
Exergame
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2020-11-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-centre, single-armed, open label pilot study
Primary purpose: OTHER

Brief summary: Current guidelines recommend that adults undertake at least 150 minutes of moderate intensity physical activity or 75 minutes of vigorous physical activity per week. However, many adults fail to be physically active according to this definition of the World Health Organisation (WHO). This represents a large economic burden to healthcare systems and public health. A number of behavioural and environmental factors associated with modern lifestyles are largely responsible for the high levels of physical inactivity including; motorised transport and sedentary jobs, lack of time, limited access to adequate exercise facilities, lack of motivation, financial constraints and environmental factors including bad weather. In an attempt to overcome many of the common barriers to exercise, members of our research group developed a virtually-monitored exercise intervention that used simple on-the-spot bodyweight exercises to be performed in the participant's home without supervision or equipment. This home-based intervention was designed to be a practical and effective training strategy capable of producing metabolic and functional adaptions while removing many of the common barriers to exercise. Despite promising results, more engaging exercise strategies are needed to motivate sedentary individuals to increase their physical activity.

Inspired by current trends in the fitness market, Sphery Ltd. developed an immersive and motivating fitness exercise game (exergame), the "ExerCube". The ExerCube allows a full-body workout that concurrently challenges physical and cognitive functions and adapts to the fitness and skill level of the individual. The development of a home-based version of the ExerCube has the potential to make this system available to more individuals, reduce major barriers to exercise, and ultimately provide a strategy to improve cardio-metabolic health in the population. Innovative home-based exergames are particularly in demand given the increase in the number of people wanting to exercise at home due to the COVID-19 pandemic.

Detailed description: Current guidelines recommend that adults undertake at least 150 minutes of moderate intensity physical activity or 75 minutes of vigorous physical activity per week. Regular physical activity improves many cardiovascular and metabolic health makers including beneficial effects on body weight, insulin sensitivity, glycaemic control, lipid profile, endothelial function and aerobic capacity. Despite overwhelming evidence that an inactive lifestyle leads to chronic disease and premature death, many adults fail to meet physical activity guidelines. Physical inactivity, defined as physical activity levels less than those required for optimal health and prevention of premature death, is a public health crisis. More than 1.4 billion adults worldwide classed as physically inactive, representing a large economic burden to healthcare systems. Clearly, new strategies are urgently needed to increase physical activity participation in the increasingly inactive population.

A number of behavioural and environmental factors associated with modern lifestyle including urbanisation, mechanisation and increased motorised transport are largely responsible for the high prevalence of physical inactivity, in addition to a number of common exercise barriers. Lack of time is cited as the main barrier to exercise as many individuals feel that increasing work hours and family commitments mean they cannot achieve the physical activity guidelines. Other common barriers within the general population include limited access to exercise facilities and appropriate equipment, difficulty with transportation, inadequate financial resources, bad weather and lack of motivation to engage in regular exercise. In an attempt to overcome many of the common barriers to exercise, members of our research group developed a virtually-monitored exercise intervention that used simple on-the-spot bodyweight exercises that could be performed in the participant's home without supervision or equipment. This home-based intervention was designed to be a practical and effective training strategy capable of producing metabolic and functional adaptions while removing many of the common barriers to exercise uptake and adherence such as "intimidating" gym environments, difficulty with access to facilities, travel time and financial constraints. Although these pilot studies successfully reduced common exercise barriers, more engaging exercise strategies are needed to increase levels of physical activity in the physically inactive population.

Inspired by current trends in the fitness market, the Swiss company Sphery Ltd. developed an immersive and motivating fitness exercise game (exergame), the "ExerCube". The ExerCube provides a full-body workout that concurrently challenges physical and cognitive functions as well as adapting to the individuals' fitness and skill level. Previous research has shown that the ExerCube is an effective training method that is more enjoyable than conventional exercise training. Development of a home-based version of the ExerCube has the potential to make this system available to more individuals, and to reduce major barriers to exercise, providing an attractive strategy to improve cardio-metabolic health of the population. Innovative home-based exergames are in demand given the increase in the number of people wanting to exercise at home due to the COVID-19 pandemic.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 18-55
* Physically inactive, defined as not meeting the exercise guidelines of 150 minutes of moderate physical activity or 75 minutes of vigorous physical activity per week
* BMI 18.5 kg/m2 - 30 kg/m2
* No known cardiovascular disorders
* Able to provide written informed consent and understand instructions

Exclusion Criteria:

* Overt diabetes mellitus (type 1, type 2, other forms of diabetes)
* Pregnant, planning on becoming pregnant during the study, or breast feeding
* Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator

Primary outcomes:
measure: VO2max
timeFrame: Pre to post 6 weeks of home-based exergame training
Secondary outcomes:
measure: Wmax
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Adherence
timeFrame: 6 weeks of home-based exergame training
measure: Adherence
timeFrame: 6 weeks of training
measure: Drop-out rate
timeFrame: 6 weeks training
measure: Physical Activity Enjoyment Scale (PACES) score
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Situation Motivation Scale (SIMS)
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Qualitative interviews
timeFrame: Following 6 weeks of training
measure: Immersive Experience Questionnaire (IEQ)
timeFrame: Following 6 weeks of training
measure: Executive Functioning
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Dynamic balance
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Whole body adipose tissue
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Visceral adipose tissue
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Fat free mass
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Blood pressure
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: C-reactive protein
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Total cholesterol
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Low Density Lipoprotein
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: High Density Lipoprotein
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Triglycerides
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: HbA1c
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Fasting glucose concentration
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Fasting insulin concentration
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Mean daily glucose concentration and area under the glucose curve
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Coefficient of variation
timeFrame: Pre to post 6 weeks of home-based exergame training
measure: Mean Daily steps
timeFrame: Pre to post 6 weeks of home-based exergame training
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Study officials:
affiliation: University of Bern
name: Christoph Stettler, MD
role: PRINCIPAL_INVESTIGATOR
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