Home-Based Exercise Gaming for Physically Inactive Individuals

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04633590
Collaborator
University of Bern (Other)
20
1
1
8.3
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home-based exergaming
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single-centre, single-armed, open label pilot studyA single-centre, single-armed, open label pilot study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Home-based Exercise Gaming on Cardio-Metabolic and Cognitive Health Markers in Physically Inactive Individuals
Actual Study Start Date :
Mar 23, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: home-based exergaming

The home-based exergame intervention will take place in an unsupervised place of the participant's choosing. Participants will be provided with all of the equipment (including a television if required) and receive instructions on how to use the system. Participants will be provided with a stepped training plan with exergame session durations of 19 minutes (4x 3-minutes 45-seconds of exercise interspersed with 1 minute of rest) in weeks 1 and 2; 24-minutes (4x 5-minutes of exercise interspersed with 1 minute of rest) in week 3 and 4; and 30-minutes (5x 5-minutes of exercise interspersed with 1 minute of rest) in week 5 and 6. Sessions will be set at a vigorous intensity (≥80% heart rate maximum) and participants will be provided with individualised heart rate zones to achieve in line with heart rate maximum determined during a maximal exercise test in Visit 2. Participants will be asked to train 3 times per week.

Behavioral: Home-based exergaming
Participants will undertake one of two 6-week training interventions. In both groups participants will be asked to train 3 times per week (18 sessions total), during which adherence to the training will be measured. To monitor adherence to training and training load (exercise completion, exercise duration and heart rate achieved during workouts) throughout the 6 weeks participants will be given a heart rate monitor.

Outcome Measures

Primary Outcome Measures

  1. VO2max [Pre to post 6 weeks of home-based exergame training]

    Change in maximal aerobic capacity (VO2max)

Secondary Outcome Measures

  1. Wmax [Pre to post 6 weeks of home-based exergame training]

    Change in maximal power output (Wmax)

  2. Adherence [6 weeks of home-based exergame training]

    Training adherence indicated by the number of training sessions performed over the 6 week period

  3. Adherence [6 weeks of training]

    Training adherence indicated by the number of training sessions in which the desired exercise intensity was achieved over the 6 week period

  4. Drop-out rate [6 weeks training]

    Number of participants that drop out from the study

  5. Physical Activity Enjoyment Scale (PACES) score [Pre to post 6 weeks of home-based exergame training]

    Change in Physical Activity Enjoyment Scale (PACES) score (an 18-item scale designed to measure physical activity enjoyment)

  6. Situation Motivation Scale (SIMS) [Pre to post 6 weeks of home-based exergame training]

    Change in Situation Motivation Scale (SIMS) score

  7. Qualitative interviews [Following 6 weeks of training]

    Overall experience determined through qualitative interviews

  8. Immersive Experience Questionnaire (IEQ) [Following 6 weeks of training]

    Immersive experience during home-based exergame sessions

  9. Executive Functioning [Pre to post 6 weeks of home-based exergame training]

    Change in reaction time determined using Test for Attentional Performance

  10. Dynamic balance [Pre to post 6 weeks of home-based exergame training]

    Change in dynamic balance determined using Y-Balance Test

  11. Whole body adipose tissue [Pre to post 6 weeks of home-based exergame training]

    Change in whole body adipose tissue volume using InBody body composition analyser

  12. Visceral adipose tissue [Pre to post 6 weeks of home-based exergame training]

    Change in visceral adipose tissue mass using InBody body composition analyser

  13. Fat free mass [Pre to post 6 weeks of home-based exergame training]

    Change in fat free mass using InBody body composition analyser

  14. Blood pressure [Pre to post 6 weeks of home-based exergame training]

    Change in blood pressure (systolic, diastolic and mean)

  15. C-reactive protein [Pre to post 6 weeks of home-based exergame training]

    Change in C-reactive protein

  16. Total cholesterol [Pre to post 6 weeks of home-based exergame training]

    Change in total cholesterol

  17. Low Density Lipoprotein [Pre to post 6 weeks of home-based exergame training]

    Change in low density lipoprotein

  18. High Density Lipoprotein [Pre to post 6 weeks of home-based exergame training]

    Change in high density lipoprotein

  19. Triglycerides [Pre to post 6 weeks of home-based exergame training]

    Change in triglycerides

  20. HbA1c [Pre to post 6 weeks of home-based exergame training]

    Change in HbA1c

  21. Fasting glucose concentration [Pre to post 6 weeks of home-based exergame training]

    Change in fasting glucose concentration

  22. Fasting insulin concentration [Pre to post 6 weeks of home-based exergame training]

    Change in fasting insulin concentration

  23. Mean daily glucose concentration and area under the glucose curve [Pre to post 6 weeks of home-based exergame training]

    Change in mean daily glucose concentration and area under the glucose curve

  24. Coefficient of variation [Pre to post 6 weeks of home-based exergame training]

    Change in coefficient of variation in continuous glucose monitor

  25. Mean Daily steps [Pre to post 6 weeks of home-based exergame training]

    Change in daily steps monitored by an accelerometer in percent

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • University of Bern

Investigators

  • Principal Investigator: Christoph Stettler, MD, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT04633590
Other Study ID Numbers:
  • HomeExergame
First Posted:
Nov 18, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Inselspital, Berne

Study Results

No Results Posted as of Jun 1, 2022