HealthySenso@WorkNCT06076915
Usability and Feasibility of an Occupational Exergame-based Intervention
A study testing Exergame training in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
High levels of sustained sedentary time in office workers are associated with non-communicable diseases as e.g. cardio-vascular diseases or diabetes. Moreover, recent evidence has further suggested a relationship between prolonged sitting periods and adverse mental health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exergame training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 30 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide a signed informed consent
- Aged between 18 and 65 years
- Present at min. 2 workdays a week
Who cannot join
- Severe sensory impairments (mainly visual, auditory, color blindness)
- Planned absence from work for >2 week
- Acute or unstable chronic diseases (e.g. cardiac infarction during the last year, uncontrolled high blood pressure or cardiovascular disease, uncontrolled diabetes)
- Rapidly progressing or terminal illnesses
- Chronic respiratory disease
- Condition or therapy that weakens the immune system
- Cancer
- Serious obesity > 40kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability and Feasibility Trial of an Exergame-based Occupational Health Intervention at Two Swiss Workforce Companies
High levels of sustained sedentary time in office workers are associated with non-communicable diseases as e.g. cardio-vascular diseases or diabetes. Moreover, recent evidence has further suggested a relationship between prolonged sitting periods and adverse mental health outcomes. Based on these facts, various types of occupational health-related interventions have already been undertaken, thereby mostly focusing on physical aspects. However, a promising intervention option that has only rarely been investigated in this context, are so-called exergames, which allow a combined physical and cognitive training in a motivating and time-efficient manner. This pilot trial aims to determine the usability and feasibility of an exergame-based intervention targeting occupational health aspects, whilst secondarily exploring potential effects on physical and cognitive functions.
The study is planned for healthy (self-reported) office workers, aged between 18 and 65 years. Participants are asked to perform a minimum of 18 training sessions with a duration of 10-20 minutes during a period of six weeks. The design is planned as a two-arm crossover trial, where participants will randomly get allocated to a group, and either start with the training period or the control period (no training). After having completed the six-week training period, participants will evaluate the usability and report their experience with the exergame device. In terms of evaluation of the feasibility, adherence and attrition rates will be calculated at the end of the study. Before, after six weeks, as well as after 12 weeks, cognitive and physical assessments will be performed and questionnaires on behalf of stress experience and management will be elicited.
The findings of this pilot trial will help to explore the possibilities of designing occupational health interventions by the implementation of motor-cognitive exergames. In addition, this trial offers the possibility of exploratorily analyzing the effects of exergame training in office-workers.
Read the detailed description
Office workers spend around 65-75% of their working hours in a seated position, whereby more than 50% of this time is accumulated in prolonged periods of sustained sitting. Growing evidence has shown, that such prolonged periods of sitting have deleterious health effects, even in adults meeting the usual physical activity guidelines of 150 minutes of weekly physical activity. These negative health effects include cardiovascular disease, general higher all-cause mortality and diabetes, whose strength of association is the most consistent. Moreover, sedentary behavior is negatively associated with reduced cognitive functions, whereby the associations are largely dependent on the assessed outcomes. Reducing sedentary phases by implementing intermittent physical activity was reported providing beneficial effects on multiple systems that are relevant for brain health, such as blood pressure, sympathetic function, or vascular function.
In addition to these direct physical consequences of working seated in an office, occupational stress can exert a further negative influence on employees. Such persisting increased levels of stress can lead to high costs in both human and economic aspects, and are associated with an increased risk of high blood pressure, depression, anger, anxiety, and irritability. For this reason, companies are more and more engaging in monitoring and preventing the occurrence of a stressful working environment, by addressing office vitality. This provides the further advantage of lowering the health care costs of employees while secondarily reducing absenteeism rates.
There exists already many studies in this area, which have dealt with the topic of occupational health. A common intervention in this regard is the implementation of sit-stand working stations or dynamic workstations with pedaling or walking tasks, mainly aiming to reduce the occurrence of musculoskeletal discomfort symptoms. However, a systematic review by Shrestha et al. showed that such sit-stand desks could not imply a considerable effect on working performance, and only an inconsistent effect on musculoskeletal symptoms. Moreover, walking breaks did not affect workplace sitting time whereas computer prompts to stand up had an inconsistent effect.
This indicates, that most current studies focus on promoting occupational health through physical interventions, with the main outcome being workplace sitting time and a strong focus on musculoskeletal outcomes. However, largely neglected so far are identified links of physical activity and sedentary behavior with cognition and mental health. It seems justified to assume that increasing physical activity or reducing sedentary behavior in office workers will also effect on mental health and cognition. As a way of example, the effect of a technology-based, combined physical and cognitive training, which has already been studied in various clinical settings, has only been rarely established in the context of healthy office workers. Research that analyses how this combination affects employees' health and well-being is therefore justified.
An emerging field that targets both physical and cognitive functions, are so-called exergames Exergames are games, which require the user to move his/her body to engage with a playful environment. The simultaneous cognitive task is thereby embedded in the game design, which helps to target multiple physical and cognitive functions in a combined manner. Due to the experienced enjoyment whilst playing the games, several studies reported such exergames to increase intrinsic motivation and thus adherence. Furthermore, most of the studies have shown exergames to be feasible, safe and proved them to have a high usability, as well as acceptance in geriatric, neurological, and cardiac patients. An exergame device that was developed based on this concept of combined cognitive-motor training and specifically designed for the needs of the mentioned target groups is the Dividat Senso. The ETH spin-off Dividat AG has developed this technology-based training system, with the main target of providing an optimal system for rehabilitation purposes and usage by older adults. With its hardware consisting of a pressure-sensitive step plate, surrounded by a handrail, it allows the user to interact with the software, presented on the screen in front, by the execution of steps or shifting of the body weight.
Findings from several studies in this area of cognitive-motor training have shown above all that the addition of such a cognitive training to the conventional balance and strength exercises of elderly people provide an additional positive effect on gait initiation, divided attention, and dual-task costs while walking. Due to this evidence base, the Dividat Senso was up till now mainly deployed in the field of (geriatric) research, training centers, rehabilitation clinics, and hospitals. However, with its simple operation, as well as the short intervals of the different games (2-5 minutes), the Dividat Senso could be an optimal addition to the field of occupational health, by playfully motivating employees to exercise during short work break intervals. This is supported by the study of Glazer et al. which showed that accruing physical activity in bouts of <10 minutes may already lead to a favorable influence on the general cardiometabolic risk.
The aim of this trial is, therefore, to explore whether such a combined cognitive-motor training with the Dividat Senso could be a usable and acceptable option to promote beneficial active breaks for healthy office workers. Moreover, this trial aims to assess whether this exergame training could be a way to not only interrupt the sedentary office periods with short movement bouts but also provide an optimal cognitive stimulus, leading to positive effects regarding stress and frustration levels.
- Conditions
- Healthy
- Being tested
- Exergame training
- Keywords
- occupational health, cognitive-motor intervention, exergame, well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame trainingBehavioural
During the exergame intervention period, the participants in the respective group will be asked to train at least two times per week for 10 minutes per session. The proposed 10 to 15 min-sessions can also be split up into multiple short training slots during the day, to thus reach the targeted 10 minutes. Moreover, the participants are allowed to train even more during their "exergame-intervention" period of six weeks. However, during the control period of six weeks, they are prohibited from training on the device.
The training program will start with four pre-defined programs of the Dividat Senso (Dividat AG, Schindellegi, Switzerland; CE certification) program. This training program will be adapted weekly by the investigator to generate new stimuli through varying games and thereby also further support the motivation.
| Study group | Role | What they receive |
|---|---|---|
| G1 (Group 1) | Experimental | Experimental: Exergame Training, then Usual Daily Work
Participants of G1 first received the Exergame Training (integrated into their working schedule). After 6 weeks, they no longer received exergame training but followed their normal work schedule for another 6 weeks. Receives: Behavioral: Exergame training |
| G2 (Group 2) | Experimental | Experimental: Usual Training Work, then Exergame Training
Participants of G2 first followed their normal work schedule for 6 weeks and then received the Exergame training for another 6 weeks. Receives: Behavioral: Exergame training |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability
Score at the System Usability Scale (SUS) (for all single items and the in total) after receiving the Exergame Training for 6 weeks Higher scores imply better system usability
Measured: 6 weeks
Technology Acceptance
Score at the Tailored Technology Acceptance Model (TAM) (for all single items and the in total) items after receiving the Exergame Training for 6 weeks Higher scores imply higher acceptance
Measured: 6 weeks
Usability
Score at the Tailored usability questionnaire items after receiving the Exergame Training for 6 weeks
Measured: 6 weeks
Situational Motivation Scale (SIMS)
The SIMS is a 16-item questionnaire that measures the aspects of intrinsic motivation, identified regulation, external regulation and amotivation. This brief and versatile self-report measure asks participants to rate their agree- or disagreement to predefined statements on a 7-point Likert scale.
Measured: 6 weeks
Adherence Rate
Duration of attended exergame training sessions in relation to the duration of the recommended (2 x 10min x 6 weeks=120 minutes) sessions (in %).
Measured: 6 weeks
Attrition
Number of participants that dropped out of the study during the exergame training intervention period.
Measured: 6 weeks
Recruitment Rate
Number of participating employees in relation to the total number of employees working at the company and fulfilling the inclusion/exclusion criteria at the time the study took place.
Measured: 6 weeks
Secondary outcomes (4)
Changes in Mental Flexibility after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
The Flexibility Test measures figural cognitive flexibility (the ability to switch between different concepts). Participants need to react as fast as possible to the presented round figure, then to the angular figure, then to the round figure and so on. Reaction times (in ms) were calculated.
Measured: 6 weeks of Exergame Training
Changes in Selective Attention after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
The Arrow Test is used to measure selective attention and inhibition. A small grey dot in the middle of the screen needs to be fixated. On the right and left side of this grey dot, arrows appear, that point either to the right or left, in a randomized order. Steps then need to be performed as fast as possible in the direction where the arrowheads are pointing (and not the side where they are appearing). Reaction times (in ms) were calculated.
Measured: 6 weeks of Exergame Training
Changes in Inhibition after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
The Stroop Test measures inhibition in a combination of four subtests. Four colored circles are always presented on the screen ( front=yellow, left= red, back=green, right= blue).
During subtest (1), a square is presented in the middle, whereafter the circle with the matching color needs to be selected as fast as possible. During subtest (2), a word is presented in the middle, whereafter, the circle with the matching color needs to be selected as fast as possible. During subtest (3), word is presented in the middle, whereafter the circle needs to be selected, whose color matches the color of the letters. During subtest (4), a word appears in the middle, randomly either framed or not. If the word appears framed, the circle needs to be selected that matches the described color. If the word is unframed, the circle needs to be selected in the color of the word letters. Reaction times (in ms) were calculated in all subtests.
Measured: 6 weeks of Exergame Training
Changes in postural sway after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
Sway Test (Senso): The Sway Test is based on the widely used Romberg Test and assesses postural control. Participants will stand on the plate with their feet shoulder-width apart and their arms extended at the front, while being standing as still as possible for 30 seconds. The test will be repeated in a second condition with closed eyes, to assess the sensory contribution to the postural control as well as in a third condition on a soft mat to assess the postural control in a more challenging environment. During these three tasks, the Center of Pressure displacement (path length in mm) is measured to evaluate participants postural control.
Measured: 6 weeks of Exergame Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is designed as a two-arm crossover pilot trial. The 12-week lasting study includes three assessment points (T0, T1, T2). After signing informed consent, participants will be randomly allocated to either group 1 (G1) or group 2 (G2), using simple (unrestricted) randomization based on a random-number table. All participants perform baseline assessments at T0. Depending on their random allocation to group 1 (G1) or group 2 (G2), they will either continue with their usual daily work life (G2), or they will start the intervention period (G1) , where they will implement the exergame training plan in their working schedule. After six weeks, both groups will perform the T1 assessments, and the program will be switched, meaning G2 will perform the exergame training and G1 will have their control period. After completing the intervention at week 12, both groups will perform the final assessments (T2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eling DeBruin, Swiss Federal Institute of Technology
- Investigators
- Eling D de Bruin, Prof., Principal investigator, eling.debruin@hest.ethz.ch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076915
- Sponsor's protocol ID
- EK-2021-N-49
- Acronym
- Senso@Work
- Status last verified
- Oct 2023
- First submitted
- 15 Nov 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen C, Dieterich AV, Koh JJE, Akksilp K, Tong EH, Budtarad N, Muller AM, Anothaisintawee T, Tai BC, Rattanavipapong W, Isaranuwatchai W, Rouyard T, Nakamura R, Muller-Riemenschneider F, Teerawattananon Y. The physical activity at work (PAW) study protocol: a cluster randomised trial of a multicomponent short-break intervention to reduce sitting time and increase physical activity among office workers in Thailand. BMC Public Health. 2020 Sep 1;20(1):1332. doi: 10.1186/s12889-020-09427-5.
PubMed 32873258Teychenne M, Ball K, Salmon J. Sedentary behavior and depression among adults: a review. Int J Behav Med. 2010 Dec;17(4):246-54. doi: 10.1007/s12529-010-9075-z.
PubMed 20174982Gao Y, Nevala N, Cronin NJ, Finni T. Effects of environmental intervention on sedentary time, musculoskeletal comfort and work ability in office workers. Eur J Sport Sci. 2016 Sep;16(6):747-54. doi: 10.1080/17461391.2015.1106590. Epub 2015 Nov 3.
PubMed 26529590Aegerter AM, Deforth M, Johnston V, Ernst MJ, Volken T, Luomajoki H, Brunner B, Dratva J, Sjogaard G, Elfering A, Melloh M; NEXpro collaboration group. On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 19;21(1):391. doi: 10.1186/s12891-020-03388-x.
PubMed 32560714Buckley JP, Hedge A, Yates T, Copeland RJ, Loosemore M, Hamer M, Bradley G, Dunstan DW. The sedentary office: an expert statement on the growing case for change towards better health and productivity. Br J Sports Med. 2015 Nov;49(21):1357-62. doi: 10.1136/bjsports-2015-094618. Epub 2015 Jun 1.
PubMed 26034192Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651.
PubMed 25599350Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.
PubMed 22890825Bhammar DM, Sawyer BJ, Tucker WJ, Gaesser GA. Breaks in Sitting Time: Effects on Continuously Monitored Glucose and Blood Pressure. Med Sci Sports Exerc. 2017 Oct;49(10):2119-2130. doi: 10.1249/MSS.0000000000001315.
PubMed 28514264Dempsey PC, Sacre JW, Larsen RN, Straznicky NE, Sethi P, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Interrupting prolonged sitting with brief bouts of light walking or simple resistance activities reduces resting blood pressure and plasma noradrenaline in type 2 diabetes. J Hypertens. 2016 Dec;34(12):2376-2382. doi: 10.1097/HJH.0000000000001101.
PubMed 27512975Falck RS, Davis JC, Liu-Ambrose T. What is the association between sedentary behaviour and cognitive function? A systematic review. Br J Sports Med. 2017 May;51(10):800-811. doi: 10.1136/bjsports-2015-095551. Epub 2016 May 6.
PubMed 27153869Thosar SS, Bielko SL, Mather KJ, Johnston JD, Wallace JP. Effect of prolonged sitting and breaks in sitting time on endothelial function. Med Sci Sports Exerc. 2015 Apr;47(4):843-9. doi: 10.1249/MSS.0000000000000479.
PubMed 25137367Elo AL, Leppanen A, Jahkola A. Validity of a single-item measure of stress symptoms. Scand J Work Environ Health. 2003 Dec;29(6):444-51. doi: 10.5271/sjweh.752.
PubMed 14712852Aldana SG. Financial impact of health promotion programs: a comprehensive review of the literature. Am J Health Promot. 2001 May-Jun;15(5):296-320. doi: 10.4278/0890-1171-15.5.296.
PubMed 11502012Davis KG, Kotowski SE. Postural variability: an effective way to reduce musculoskeletal discomfort in office work. Hum Factors. 2014 Nov;56(7):1249-61. doi: 10.1177/0018720814528003.
PubMed 25490805Schellewald V, Kleinert J, Ellegast R. Effects of two types of dynamic office workstations (DOWs) used at two intensities on cognitive performance and office work in tasks with various complexity. Ergonomics. 2021 Jun;64(6):806-818. doi: 10.1080/00140139.2020.1862308. Epub 2020 Dec 23.
PubMed 33289621
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Feasibility Trial of an Exergame-based Occupational Health Intervention at Two Swiss Workforce Companies
- ClinicalTrials.gov ID
- NCT06076915
- Acronym / sponsor ID
- Senso@Work / EK-2021-N-49
- Conditions
- Healthy
- Keywords
- occupational health, cognitive-motor intervention, exergame, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Oct 2023 (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.
High levels of sustained sedentary time in office workers are associated with non-communicable diseases as e.g. cardio-vascular diseases or diabetes. Moreover, recent evidence has further suggested a relationship between prolonged sitting periods and adverse mental health outcomes. Based on these facts, various types of occupational health-related interventions have already been undertaken, thereby mostly focusing on physical aspects. However, a promising intervention option that has only rarely been investigated in this context, are so-called exergames, which allow a combined physical and cognitive training in a motivating and time-efficient manner. This pilot trial aims to determine the usability and feasibility of an exergame-based intervention targeting occupational health aspects, whilst secondarily exploring potential effects on physical and cognitive functions.
The study is planned for healthy (self-reported) office workers, aged between 18 and 65 years. Participants are asked to perform a minimum of 18 training sessions with a duration of 10-20 minutes during a period of six weeks. The design is planned as a two-arm crossover trial, where participants will randomly get allocated to a group, and either start with the training period or the control period (no training). After having completed the six-week training period, participants will evaluate the usability and report their experience with the exergame device. In terms of evaluation of the feasibility, adherence and attrition rates will be calculated at the end of the study. Before, after six weeks, as well as after 12 weeks, cognitive and physical assessments will be performed and questionnaires on behalf of stress experience and management will be elicited.
The findings of this pilot trial will help to explore the possibilities of designing occupational health interventions by the implementation of motor-cognitive exergames. In addition, this trial offers the possibility of exploratorily analyzing the effects of exergame training in office-workers.
Detailed description
Office workers spend around 65-75% of their working hours in a seated position, whereby more than 50% of this time is accumulated in prolonged periods of sustained sitting. Growing evidence has shown, that such prolonged periods of sitting have deleterious health effects, even in adults meeting the usual physical activity guidelines of 150 minutes of weekly physical activity. These negative health effects include cardiovascular disease, general higher all-cause mortality and diabetes, whose strength of association is the most consistent. Moreover, sedentary behavior is negatively associated with reduced cognitive functions, whereby the associations are largely dependent on the assessed outcomes. Reducing sedentary phases by implementing intermittent physical activity was reported providing beneficial effects on multiple systems that are relevant for brain health, such as blood pressure, sympathetic function, or vascular function.
In addition to these direct physical consequences of working seated in an office, occupational stress can exert a further negative influence on employees. Such persisting increased levels of stress can lead to high costs in both human and economic aspects, and are associated with an increased risk of high blood pressure, depression, anger, anxiety, and irritability. For this reason, companies are more and more engaging in monitoring and preventing the occurrence of a stressful working environment, by addressing office vitality. This provides the further advantage of lowering the health care costs of employees while secondarily reducing absenteeism rates.
There exists already many studies in this area, which have dealt with the topic of occupational health. A common intervention in this regard is the implementation of sit-stand working stations or dynamic workstations with pedaling or walking tasks, mainly aiming to reduce the occurrence of musculoskeletal discomfort symptoms. However, a systematic review by Shrestha et al. showed that such sit-stand desks could not imply a considerable effect on working performance, and only an inconsistent effect on musculoskeletal symptoms. Moreover, walking breaks did not affect workplace sitting time whereas computer prompts to stand up had an inconsistent effect.
This indicates, that most current studies focus on promoting occupational health through physical interventions, with the main outcome being workplace sitting time and a strong focus on musculoskeletal outcomes. However, largely neglected so far are identified links of physical activity and sedentary behavior with cognition and mental health. It seems justified to assume that increasing physical activity or reducing sedentary behavior in office workers will also effect on mental health and cognition. As a way of example, the effect of a technology-based, combined physical and cognitive training, which has already been studied in various clinical settings, has only been rarely established in the context of healthy office workers. Research that analyses how this combination affects employees' health and well-being is therefore justified.
An emerging field that targets both physical and cognitive functions, are so-called exergames Exergames are games, which require the user to move his/her body to engage with a playful environment. The simultaneous cognitive task is thereby embedded in the game design, which helps to target multiple physical and cognitive functions in a combined manner. Due to the experienced enjoyment whilst playing the games, several studies reported such exergames to increase intrinsic motivation and thus adherence. Furthermore, most of the studies have shown exergames to be feasible, safe and proved them to have a high usability, as well as acceptance in geriatric, neurological, and cardiac patients. An exergame device that was developed based on this concept of combined cognitive-motor training and specifically designed for the needs of the mentioned target groups is the Dividat Senso. The ETH spin-off Dividat AG has developed this technology-based training system, with the main target of providing an optimal system for rehabilitation purposes and usage by older adults. With its hardware consisting of a pressure-sensitive step plate, surrounded by a handrail, it allows the user to interact with the software, presented on the screen in front, by the execution of steps or shifting of the body weight.
Findings from several studies in this area of cognitive-motor training have shown above all that the addition of such a cognitive training to the conventional balance and strength exercises of elderly people provide an additional positive effect on gait initiation, divided attention, and dual-task costs while walking. Due to this evidence base, the Dividat Senso was up till now mainly deployed in the field of (geriatric) research, training centers, rehabilitation clinics, and hospitals. However, with its simple operation, as well as the short intervals of the different games (2-5 minutes), the Dividat Senso could be an optimal addition to the field of occupational health, by playfully motivating employees to exercise during short work break intervals. This is supported by the study of Glazer et al. which showed that accruing physical activity in bouts of <10 minutes may already lead to a favorable influence on the general cardiometabolic risk.
The aim of this trial is, therefore, to explore whether such a combined cognitive-motor training with the Dividat Senso could be a usable and acceptable option to promote beneficial active breaks for healthy office workers. Moreover, this trial aims to assess whether this exergame training could be a way to not only interrupt the sedentary office periods with short movement bouts but also provide an optimal cognitive stimulus, leading to positive effects regarding stress and frustration levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a two-arm crossover pilot trial. The 12-week lasting study includes three assessment points (T0, T1, T2). After signing informed consent, participants will be randomly allocated to either group 1 (G1) or group 2 (G2), using simple (unrestricted) randomization based on a random-number table. All participants perform baseline assessments at T0. Depending on their random allocation to group 1 (G1) or group 2 (G2), they will either continue with their usual daily work life (G2), or they will start the intervention period (G1) , where they will implement the exergame training plan in their working schedule. After six weeks, both groups will perform the T1 assessments, and the program will be switched, meaning G2 will perform the exergame training and G1 will have their control period. After completing the intervention at week 12, both groups will perform the final assessments (T2).
| Arm | Type | Receives |
|---|---|---|
| G1 (Group 1) | Experimental | Behavioral: Exergame trainingExperimental: Exergame Training, then Usual Daily Work Participants of G1 first received the Exergame Training (integrated into their working schedule). After 6 weeks, they no longer received exergame training but followed their normal work schedule for another 6 weeks. |
| G2 (Group 2) | Experimental | Behavioral: Exergame trainingExperimental: Usual Training Work, then Exergame Training Participants of G2 first followed their normal work schedule for 6 weeks and then received the Exergame training for another 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide a signed informed consent
- Aged between 18 and 65 years
- Present at min. 2 workdays a week
Key exclusion criteria (8 listed)
- Severe sensory impairments (mainly visual, auditory, color blindness)
- Planned absence from work for >2 week
- Acute or unstable chronic diseases (e.g. cardiac infarction during the last year, uncontrolled high blood pressure or cardiovascular disease, uncontrolled diabetes)
- Rapidly progressing or terminal illnesses
- Chronic respiratory disease
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 |
|---|---|---|
| Exergame trainingDuring the exergame intervention period, the participants in the respective group will be asked to train at least two times per week for 10 minutes per session. The proposed 10 to 15 min-sessions can also be split up into multiple short training slots during the day, to thus reach the targeted 10 minutes. Moreover, the participants are allowed to train even more during their "exergame-intervention" period of six weeks. However, during the control period of six weeks, they are prohibited from training on the device. The training program will start with four pre-defined programs of the Dividat Senso (Dividat AG, Schindellegi, Switzerland; CE certification) program. This training program will be adapted weekly by the investigator to generate new stimuli through varying games and thereby also further support the motivation. | Behavioural | G1 (Group 1), G2 (Group 2) |
Primary outcome
System Usability
Time frame: 6 weeks
Score at the System Usability Scale (SUS) (for all single items and the in total) after receiving the Exergame Training for 6 weeks Higher scores imply better system usability
Technology Acceptance
Time frame: 6 weeks
Score at the Tailored Technology Acceptance Model (TAM) (for all single items and the in total) items after receiving the Exergame Training for 6 weeks Higher scores imply higher acceptance
Usability
Time frame: 6 weeks
Score at the Tailored usability questionnaire items after receiving the Exergame Training for 6 weeks
Situational Motivation Scale (SIMS)
Time frame: 6 weeks
The SIMS is a 16-item questionnaire that measures the aspects of intrinsic motivation, identified regulation, external regulation and amotivation. This brief and versatile self-report measure asks participants to rate their agree- or disagreement to predefined statements on a 7-point Likert scale.
Adherence Rate
Time frame: 6 weeks
Duration of attended exergame training sessions in relation to the duration of the recommended (2 x 10min x 6 weeks=120 minutes) sessions (in %).
Attrition
Time frame: 6 weeks
Number of participants that dropped out of the study during the exergame training intervention period.
Recruitment Rate
Time frame: 6 weeks
Number of participating employees in relation to the total number of employees working at the company and fulfilling the inclusion/exclusion criteria at the time the study took place.
4 secondary outcomes
Changes in Mental Flexibility after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
Time frame: 6 weeks of Exergame Training
Changes in Selective Attention after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
Time frame: 6 weeks of Exergame Training
Changes in Inhibition after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
Time frame: 6 weeks of Exergame Training
Changes in postural sway after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
Time frame: 6 weeks of 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 11 Oct 2023.
- Background: PubMed 32873258Chen C, Dieterich AV, Koh JJE, Akksilp K, Tong EH, Budtarad N, Muller AM, Anothaisintawee T, Tai BC, Rattanavipapong W, Isaranuwatchai W, Rouyard T, Nakamura R, Muller-Riemenschneider F, Teerawattananon Y. The physical activity at work (PAW) study protocol: a cluster randomised trial of a multicomponent short-break intervention to reduce sitting time and increase physical activity among office workers in Thailand. BMC Public Health. 2020 Sep 1;20(1):1332. doi: 10.1186/s12889-020-09427-5.
- Background: PubMed 20174982Teychenne M, Ball K, Salmon J. Sedentary behavior and depression among adults: a review. Int J Behav Med. 2010 Dec;17(4):246-54. doi: 10.1007/s12529-010-9075-z.
- Background: PubMed 26529590Gao Y, Nevala N, Cronin NJ, Finni T. Effects of environmental intervention on sedentary time, musculoskeletal comfort and work ability in office workers. Eur J Sport Sci. 2016 Sep;16(6):747-54. doi: 10.1080/17461391.2015.1106590. Epub 2015 Nov 3.
- Background: PubMed 32560714Aegerter AM, Deforth M, Johnston V, Ernst MJ, Volken T, Luomajoki H, Brunner B, Dratva J, Sjogaard G, Elfering A, Melloh M; NEXpro collaboration group. On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 19;21(1):391. doi: 10.1186/s12891-020-03388-x.
- Background: PubMed 26034192Buckley JP, Hedge A, Yates T, Copeland RJ, Loosemore M, Hamer M, Bradley G, Dunstan DW. The sedentary office: an expert statement on the growing case for change towards better health and productivity. Br J Sports Med. 2015 Nov;49(21):1357-62. doi: 10.1136/bjsports-2015-094618. Epub 2015 Jun 1.
- Background: PubMed 25599350Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651.
- Background: PubMed 22890825Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.
- Background: PubMed 28514264Bhammar DM, Sawyer BJ, Tucker WJ, Gaesser GA. Breaks in Sitting Time: Effects on Continuously Monitored Glucose and Blood Pressure. Med Sci Sports Exerc. 2017 Oct;49(10):2119-2130. doi: 10.1249/MSS.0000000000001315.
- Background: PubMed 27512975Dempsey PC, Sacre JW, Larsen RN, Straznicky NE, Sethi P, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW. Interrupting prolonged sitting with brief bouts of light walking or simple resistance activities reduces resting blood pressure and plasma noradrenaline in type 2 diabetes. J Hypertens. 2016 Dec;34(12):2376-2382. doi: 10.1097/HJH.0000000000001101.
- Background: PubMed 27153869Falck RS, Davis JC, Liu-Ambrose T. What is the association between sedentary behaviour and cognitive function? A systematic review. Br J Sports Med. 2017 May;51(10):800-811. doi: 10.1136/bjsports-2015-095551. Epub 2016 May 6.
- Background: PubMed 25137367Thosar SS, Bielko SL, Mather KJ, Johnston JD, Wallace JP. Effect of prolonged sitting and breaks in sitting time on endothelial function. Med Sci Sports Exerc. 2015 Apr;47(4):843-9. doi: 10.1249/MSS.0000000000000479.
- Background: PubMed 14712852Elo AL, Leppanen A, Jahkola A. Validity of a single-item measure of stress symptoms. Scand J Work Environ Health. 2003 Dec;29(6):444-51. doi: 10.5271/sjweh.752.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Eling D de Bruin, Prof. principal investigator
eling.debruin@hest.ethz.ch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame training in people with Healthy, run by Swiss Federal Institute of Technology 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 3 inclusion and 8 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 11 Oct 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?
System Usability (time frame: 6 weeks). The study lists 7 primary outcomes in all. 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 NCT06076915, which also lists 35 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 11 Oct 2023.