Physical InactivityNCT04633590
Home-Based Exercise Gaming for Physically Inactive Individuals
A study testing Home-based exergaming in people with Physical Inactivity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Home-based exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Mar 2022to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, 3010
About this study
Official title: Effects of Home-based Exercise Gaming on Cardio-Metabolic and Cognitive Health Markers in Physically Inactive Individuals
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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Home-based exergaming
- Keywords
- Home-based exercise gaming, Cardiovascular health, Neurocognitive health, Physical Inactivity, Exergame
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exergamingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| home-based exergaming | Experimental | 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. Receives: Behavioral: Home-based exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Change in maximal aerobic capacity (VO2max)
Measured: Pre to post 6 weeks of home-based exergame training
Secondary outcomes (25)
Wmax
Change in maximal power output (Wmax)
Measured: Pre to post 6 weeks of home-based exergame training
Adherence
Training adherence indicated by the number of training sessions performed over the 6 week period
Measured: 6 weeks of home-based exergame training
Adherence
Training adherence indicated by the number of training sessions in which the desired exercise intensity was achieved over the 6 week period
Measured: 6 weeks of training
Drop-out rate
Number of participants that drop out from the study
Measured: 6 weeks training
Physical Activity Enjoyment Scale (PACES) score
Change in Physical Activity Enjoyment Scale (PACES) score (an 18-item scale designed to measure physical activity enjoyment)
Measured: Pre to post 6 weeks of home-based exergame training
Situation Motivation Scale (SIMS)
Change in Situation Motivation Scale (SIMS) score
Measured: Pre to post 6 weeks of home-based exergame training
Qualitative interviews
Overall experience determined through qualitative interviews
Measured: Following 6 weeks of training
Immersive Experience Questionnaire (IEQ)
Immersive experience during home-based exergame sessions
Measured: Following 6 weeks of training
Executive Functioning
Change in reaction time determined using Test for Attentional Performance
Measured: Pre to post 6 weeks of home-based exergame training
Dynamic balance
Change in dynamic balance determined using Y-Balance Test
Measured: Pre to post 6 weeks of home-based exergame training
Whole body adipose tissue
Change in whole body adipose tissue volume using InBody body composition analyser
Measured: Pre to post 6 weeks of home-based exergame training
Visceral adipose tissue
Change in visceral adipose tissue mass using InBody body composition analyser
Measured: Pre to post 6 weeks of home-based exergame training
Fat free mass
Change in fat free mass using InBody body composition analyser
Measured: Pre to post 6 weeks of home-based exergame training
Blood pressure
Change in blood pressure (systolic, diastolic and mean)
Measured: Pre to post 6 weeks of home-based exergame training
C-reactive protein
Change in C-reactive protein
Measured: Pre to post 6 weeks of home-based exergame training
Total cholesterol
Change in total cholesterol
Measured: Pre to post 6 weeks of home-based exergame training
Low Density Lipoprotein
Change in low density lipoprotein
Measured: Pre to post 6 weeks of home-based exergame training
High Density Lipoprotein
Change in high density lipoprotein
Measured: Pre to post 6 weeks of home-based exergame training
Triglycerides
Change in triglycerides
Measured: Pre to post 6 weeks of home-based exergame training
HbA1c
Change in HbA1c
Measured: Pre to post 6 weeks of home-based exergame training
Fasting glucose concentration
Change in fasting glucose concentration
Measured: Pre to post 6 weeks of home-based exergame training
Fasting insulin concentration
Change in fasting insulin concentration
Measured: Pre to post 6 weeks of home-based exergame training
Mean daily glucose concentration and area under the glucose curve
Change in mean daily glucose concentration and area under the glucose curve
Measured: Pre to post 6 weeks of home-based exergame training
Coefficient of variation
Change in coefficient of variation in continuous glucose monitor
Measured: Pre to post 6 weeks of home-based exergame training
Mean Daily steps
Change in daily steps monitored by an accelerometer in percent
Measured: Pre to post 6 weeks of home-based exergame training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start23 Mar 2022
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-centre, single-armed, open label pilot study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Christoph Stettler, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633590
- Sponsor's protocol ID
- HomeExergame
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amanat S, Ghahri S, Dianatinasab A, Fararouei M, Dianatinasab M. Exercise and Type 2 Diabetes. Adv Exp Med Biol. 2020;1228:91-105. doi: 10.1007/978-981-15-1792-1_6.
PubMed 32342452Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
PubMed 23798298Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Chtourou H, Trabelsi K, H'mida C, Boukhris O, Glenn JM, Brach M, Bentlage E, Bott N, Shephard RJ, Ammar A, Bragazzi NL. Staying Physically Active During the Quarantine and Self-Isolation Period for Controlling and Mitigating the COVID-19 Pandemic: A Systematic Overview of the Literature. Front Psychol. 2020 Aug 19;11:1708. doi: 10.3389/fpsyg.2020.01708. eCollection 2020.
PubMed 33013497Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.
PubMed 27475266Donath L, Roth R, Hurlimann C, Zahner L, Faude O. Pilates vs. Balance Training in Health Community-Dwelling Seniors: a 3-arm, Randomized Controlled Trial. Int J Sports Med. 2016 Mar;37(3):202-10. doi: 10.1055/s-0035-1559695. Epub 2015 Dec 2.
PubMed 26630547Franklin BA, Bonzheim K, Gordon S, Timmis GC. Safety of medically supervised outpatient cardiac rehabilitation exercise therapy: a 16-year follow-up. Chest. 1998 Sep;114(3):902-6. doi: 10.1378/chest.114.3.902. No abstract available.
PubMed 9743182Gibbons 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.
PubMed 12356646Gibbons 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.
PubMed 9207652Guthold 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.
PubMed 30193830Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U; Lancet Physical Activity Series Working Group. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012 Jul 21;380(9838):247-57. doi: 10.1016/S0140-6736(12)60646-1.
PubMed 22818937Jekauc 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.
PubMed 33206685Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
PubMed 22818941Morgan F, Battersby A, Weightman AL, Searchfield L, Turley R, Morgan H, Jagroo J, Ellis S. Adherence to exercise referral schemes by participants - what do providers and commissioners need to know? A systematic review of barriers and facilitators. BMC Public Health. 2016 Mar 5;16:227. doi: 10.1186/s12889-016-2882-7.
PubMed 26944952Motl 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.
PubMed 11457630
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Exercise Gaming on Cardio-Metabolic and Cognitive Health Markers in Physically Inactive Individuals
- ClinicalTrials.gov ID
- NCT04633590
- Acronym / sponsor ID
- HomeExergame
- Conditions
- Physical Inactivity
- Keywords
- Home-based exercise gaming, Cardiovascular health, Neurocognitive health, Physical Inactivity, Exergame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-centre, single-armed, open label pilot study
| Arm | Type | Receives |
|---|---|---|
| home-based exergaming | Experimental | Behavioral: Home-based exergamingThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exergamingParticipants 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. | Behavioural | home-based exergaming |
Primary outcome
VO2max
Time frame: Pre to post 6 weeks of home-based exergame training
Change in maximal aerobic capacity (VO2max)
25 secondary outcomes
Wmax
Time frame: Pre to post 6 weeks of home-based exergame training
Adherence
Time frame: 6 weeks of home-based exergame training
Adherence
Time frame: 6 weeks of training
Drop-out rate
Time frame: 6 weeks training
Physical Activity Enjoyment Scale (PACES) score
Time frame: Pre to post 6 weeks of home-based exergame training
Situation Motivation Scale (SIMS)
Time frame: Pre to post 6 weeks of home-based exergame training
Qualitative interviews
Time frame: Following 6 weeks of training
Immersive Experience Questionnaire (IEQ)
Time frame: Following 6 weeks of training
Executive Functioning
Time frame: Pre to post 6 weeks of home-based exergame training
Dynamic balance
Time frame: Pre to post 6 weeks of home-based exergame training
Whole body adipose tissue
Time frame: Pre to post 6 weeks of home-based exergame training
Visceral adipose tissue
Time frame: Pre to post 6 weeks of home-based exergame training
Fat free mass
Time frame: Pre to post 6 weeks of home-based exergame training
Blood pressure
Time frame: Pre to post 6 weeks of home-based exergame training
C-reactive protein
Time frame: Pre to post 6 weeks of home-based exergame training
Total cholesterol
Time frame: Pre to post 6 weeks of home-based exergame training
Low Density Lipoprotein
Time frame: Pre to post 6 weeks of home-based exergame training
High Density Lipoprotein
Time frame: Pre to post 6 weeks of home-based exergame training
Triglycerides
Time frame: Pre to post 6 weeks of home-based exergame training
HbA1c
Time frame: Pre to post 6 weeks of home-based exergame training
Fasting glucose concentration
Time frame: Pre to post 6 weeks of home-based exergame training
Fasting insulin concentration
Time frame: Pre to post 6 weeks of home-based exergame training
Mean daily glucose concentration and area under the glucose curve
Time frame: Pre to post 6 weeks of home-based exergame training
Coefficient of variation
Time frame: Pre to post 6 weeks of home-based exergame training
Mean Daily steps
Time frame: Pre to post 6 weeks of home-based exergame training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 32342452Amanat S, Ghahri S, Dianatinasab A, Fararouei M, Dianatinasab M. Exercise and Type 2 Diabetes. Adv Exp Med Biol. 2020;1228:91-105. doi: 10.1007/978-981-15-1792-1_6.
- Background: PubMed 23798298Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 33013497Chtourou H, Trabelsi K, H'mida C, Boukhris O, Glenn JM, Brach M, Bentlage E, Bott N, Shephard RJ, Ammar A, Bragazzi NL. Staying Physically Active During the Quarantine and Self-Isolation Period for Controlling and Mitigating the COVID-19 Pandemic: A Systematic Overview of the Literature. Front Psychol. 2020 Aug 19;11:1708. doi: 10.3389/fpsyg.2020.01708. eCollection 2020.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Stettler, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exergaming in people with Physical Inactivity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: Pre to post 6 weeks of home-based exergame training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633590, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.