跳至主要内容
临床试验/NCT06076915
NCT06076915已完成不适用

Usability and Feasibility Trial of an Exergame-based Occupational Health Intervention at Two Swiss Workforce Companies

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Usability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcome evaluator of the pre- and post-measurement was blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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
  • •Serious obesity > 40kg/m2

研究组 & 干预措施

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.

干预措施: Exergame training (Behavioral)

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.

干预措施: Exergame training (Behavioral)

结局指标

主要结局

Usability

时间窗: 6 weeks

Score at the Tailored usability questionnaire items after receiving the Exergame Training for 6 weeks

System Usability

时间窗: 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

Recruitment Rate

时间窗: 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.

Technology Acceptance

时间窗: 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

Situational Motivation Scale (SIMS)

时间窗: 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

时间窗: 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

时间窗: 6 weeks

Number of participants that dropped out of the study during the exergame training intervention period.

次要结局

  • Changes in Selective Attention after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)(6 weeks of Exergame Training)
  • Changes in Mental Flexibility after 6 weeks of Exergame Training (from T1 to T2 (for G1) and from T2 to T3 (for G2)(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)(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)(6 weeks of Exergame Training)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eling DeBruin

Prof.

Swiss Federal Institute of Technology

研究点 (1)

Loading locations...

相似试验