Home-Based Exercise Gaming for Physically Inactive Individuals

Physical Inactivity Clinical Trial

Official title:

Effects of Home-based Exercise Gaming on Cardio-Metabolic and Cognitive Health Markers in Physically Inactive Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633590
• Other study ID #: HomeExergame
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (23)

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Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD Jr, Winters WL, Yanowitz FG, Ritchie JL, Gibbons RJ, Cheitlin MD, Eagle KA, Gardner TJ, Garson A Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA Guidelines for Exercise Testing. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). J Am Coll Cardiol. 1997 Jul;30(1):260-311. doi: 10.1016/s0735-1097(97)00150-2. No abstract available. — View Citation

Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. doi: 10.1161/01.cir.0000034670.06526.15. No abstract available. — View Citation

Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4. Erratum In: Lancet Glob Health. 2019 Jan;7(1):e36. — View Citation

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Jekauc D, Nigg C, Nigg CR, Reichert M, Krell-Roesch J, Oriwol D, Schmidt S, Wunsch K, Woll A. Measurement properties of the German version of the Physical Activity Enjoyment Scale for adults. PLoS One. 2020 Nov 18;15(11):e0242069. doi: 10.1371/journal.pone.0242069. eCollection 2020. — View Citation

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Motl RW, Dishman RK, Saunders R, Dowda M, Felton G, Pate RR. Measuring enjoyment of physical activity in adolescent girls. Am J Prev Med. 2001 Aug;21(2):110-7. doi: 10.1016/s0749-3797(01)00326-9. Erratum In: Am J Prev Med 2001 Nov;21(4):332. — View Citation

Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801. doi: 10.1056/NEJMoa011858. — View Citation

Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. doi: 10.1161/01.cir.0000048890.59383.8d. No abstract available. — View Citation

Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9. — View Citation

Scott SN, Shepherd SO, Andrews RC, Narendran P, Purewal TS, Kinnafick F, Cuthbertson DJ, Atkinson-Goulding S, Noon T, Wagenmakers AJM, Cocks M. A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. Diabetes Care. 2019 Dec;42(12):2330-2333. doi: 10.2337/dc19-0871. Epub 2019 Sep 17. — View Citation

Scott SN, Shepherd SO, Hopkins N, Dawson EA, Strauss JA, Wright DJ, Cooper RG, Kumar P, Wagenmakers AJM, Cocks M. Home-hit improves muscle capillarisation and eNOS/NAD(P)Hoxidase protein ratio in obese individuals with elevated cardiovascular disease risk. J Physiol. 2019 Aug;597(16):4203-4225. doi: 10.1113/JP278062. Epub 2019 Jul 15. — View Citation

Shepherd SO, Cocks M, Tipton KD, Ranasinghe AM, Barker TA, Burniston JG, Wagenmakers AJ, Shaw CS. Sprint interval and traditional endurance training increase net intramuscular triglyceride breakdown and expression of perilipin 2 and 5. J Physiol. 2013 Feb 1;591(3):657-75. doi: 10.1113/jphysiol.2012.240952. Epub 2012 Nov 5. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2max	Change in maximal aerobic capacity (VO2max)	Pre to post 6 weeks of home-based exergame training
Secondary	Wmax	Change in maximal power output (Wmax)	Pre to post 6 weeks of home-based exergame training
Secondary	Adherence	Training adherence indicated by the number of training sessions performed over the 6 week period	6 weeks of home-based exergame training
Secondary	Adherence	Training adherence indicated by the number of training sessions in which the desired exercise intensity was achieved over the 6 week period	6 weeks of training
Secondary	Drop-out rate	Number of participants that drop out from the study	6 weeks training
Secondary	Physical Activity Enjoyment Scale (PACES) score	Change in Physical Activity Enjoyment Scale (PACES) score (an 18-item scale designed to measure physical activity enjoyment)	Pre to post 6 weeks of home-based exergame training
Secondary	Situation Motivation Scale (SIMS)	Change in Situation Motivation Scale (SIMS) score	Pre to post 6 weeks of home-based exergame training
Secondary	Qualitative interviews	Overall experience determined through qualitative interviews	Following 6 weeks of training
Secondary	Immersive Experience Questionnaire (IEQ)	Immersive experience during home-based exergame sessions	Following 6 weeks of training
Secondary	Executive Functioning	Change in reaction time determined using Test for Attentional Performance	Pre to post 6 weeks of home-based exergame training
Secondary	Dynamic balance	Change in dynamic balance determined using Y-Balance Test	Pre to post 6 weeks of home-based exergame training
Secondary	Whole body adipose tissue	Change in whole body adipose tissue volume using InBody body composition analyser	Pre to post 6 weeks of home-based exergame training
Secondary	Visceral adipose tissue	Change in visceral adipose tissue mass using InBody body composition analyser	Pre to post 6 weeks of home-based exergame training
Secondary	Fat free mass	Change in fat free mass using InBody body composition analyser	Pre to post 6 weeks of home-based exergame training
Secondary	Blood pressure	Change in blood pressure (systolic, diastolic and mean)	Pre to post 6 weeks of home-based exergame training
Secondary	C-reactive protein	Change in C-reactive protein	Pre to post 6 weeks of home-based exergame training
Secondary	Total cholesterol	Change in total cholesterol	Pre to post 6 weeks of home-based exergame training
Secondary	Low Density Lipoprotein	Change in low density lipoprotein	Pre to post 6 weeks of home-based exergame training
Secondary	High Density Lipoprotein	Change in high density lipoprotein	Pre to post 6 weeks of home-based exergame training
Secondary	Triglycerides	Change in triglycerides	Pre to post 6 weeks of home-based exergame training
Secondary	HbA1c	Change in HbA1c	Pre to post 6 weeks of home-based exergame training
Secondary	Fasting glucose concentration	Change in fasting glucose concentration	Pre to post 6 weeks of home-based exergame training
Secondary	Fasting insulin concentration	Change in fasting insulin concentration	Pre to post 6 weeks of home-based exergame training
Secondary	Mean daily glucose concentration and area under the glucose curve	Change in mean daily glucose concentration and area under the glucose curve	Pre to post 6 weeks of home-based exergame training
Secondary	Coefficient of variation	Change in coefficient of variation in continuous glucose monitor	Pre to post 6 weeks of home-based exergame training
Secondary	Mean Daily steps	Change in daily steps monitored by an accelerometer in percent	Pre to post 6 weeks of home-based exergame training