Usability and Feasibility of an Occupational Exergame-based Intervention

NCT06076915 | Completed

• 1 other identifier: EK-2021-N-49
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

occupational health; cognitive-motor intervention; exergame; well-being

Outcome Measures

Primary Outcomes (7)

• 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

  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

  6 weeks

• Usability

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

  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.

  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 %).

  6 weeks

• Attrition

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

  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.

  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)

  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)

  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

Study Arms (2)

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.

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.

Behavioral: Exergame training

Interventions

Exergame training BEHAVIORAL

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.

G1 (Group 1); G2 (Group 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Baryon AG

Zurich, Canton of Zurich, 8002, Switzerland

Location

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Study Officials

• Eling D de Bruin, Prof.

  eling.debruin@hest.ethz.ch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator of the pre- and post-measurement was blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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).

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: October 11, 2023
• Study Start: June 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)