Clinical trial NCT06076915: Usability and Feasibility of an Occupational Exergame-based Intervention
Official title: Usability and Feasibility Trial of an Exergame-based Occupational Health Intervention at Two Swiss Workforce Companies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: occupational health
cognitive-motor intervention
exergame
well-being
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Provide a signed informed consent
* Aged between 18 and 65 years
* Present at min. 2 workdays a week

Exclusion Criteria:

* 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

Primary outcomes:
measure: System Usability
timeFrame: 6 weeks
measure: Technology Acceptance
timeFrame: 6 weeks
measure: Usability
timeFrame: 6 weeks
measure: Situational Motivation Scale (SIMS)
timeFrame: 6 weeks
measure: Adherence Rate
timeFrame: 6 weeks
measure: Attrition
timeFrame: 6 weeks
measure: Recruitment Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in Mental Flexibility after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
timeFrame: 6 weeks of Exergame Training
measure: Changes in Selective Attention after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
timeFrame: 6 weeks of Exergame Training
measure: Changes in Inhibition after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
timeFrame: 6 weeks of Exergame Training
measure: Changes in postural sway after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)
timeFrame: 6 weeks of Exergame Training
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Baryon AG
state: ZH
Study officials:
affiliation: eling.debruin@hest.ethz.ch
name: Eling D de Bruin, Prof.
role: PRINCIPAL_INVESTIGATOR
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