Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training: Formative Pilot Randomized Trial

Background Sport science can play a critical role in reducing health inequalities. The inverse relationship between life expectancy, cardiorespiratory fitness, and socioeconomic status could be addressed by performing high-intensity training (HIT), delivered in a class salient and accessible approach. Commercially available exergames have shown encouraging compliance rates but are primarily designed for entertainment purposes rather than focusing on health-related outcomes. A serious game tailored toward delivering an exercise stimulus, while reducing the aversive protocols associated with HIT, could be beneficial to engage and improve health outcomes in socially deprived males. Objective The aims of this study were to develop an exergame capable of delivering HIT and evaluate the effect on selected health outcomes in men recruited in regions of socioeconomic deprivation. Methods We conducted an exploratory trial in our target population, and participants were allocated to intervention (n=14) or control groups (n=10) by third-party minimization. The intervention was a 6-week training program consisting of three sessions of exergaming per week. The sessions involved a structured warm-up, then brief intermittent repetitions in the form of boxing rounds (10 s, 20 s, and 30 s) against their peers with a work/rest ratio of 0.25. Results Retention to the intervention was 87.5% (21/24). Over the duration of the intervention, session attendance was 67.5% (170/252); repetition mean and peak heart rates (% of maximal) and session ratings of perceived exertion (AU, arbitrary units) were 86.3 (5.4%), 89.9 (6.1%), and 7.5 (2.2 AU), respectively. The effect of the intervention, when compared with the control, was a likely small beneficial improvement in predicted maximum oxygen consumption (VO2 max, 3.0; 90% confidence limits ±2.6%). Effects on body mass, waist circumference, and blood pressure were either trivial or unclear. Conclusions Over the 6-week intervention, the exergame delivered a consistent and sustained dose of HIT, with some beneficial effects on aerobic fitness in the target population. Trial Registration ClinicalTrials.gov NCT03477773; https://clinicaltrials.gov/ct2/show/NCT03477773 (Archived by WebCite at http://www.webcitation.org/6yDLgVs35)


INTRODUCTION 2a-i) Problem and the type of system/solution 2a-ii) Scientific background, rationale: What is known about the (type of) system
Yes. "The latest government audit of university-based research in the United Kingdom has highlighted the need for more sport and exercise research to target health inequalities that persist in society [1]. There are strong inverse relationships between life expectancy, cardiorespiratory fitness, and socioeconomic status [2][3][4]. As these trends are exacerbated in males, improving fitness in men living in regions of socioeconomic deprivation could be important for addressing health inequalities. High-intensity training (HIT) is a timeefficient way to improve fitness over a short duration [5], and a growing body of evidence advocates this form of exercise for public health interventions [6]. HIT is known to stimulate a combination of central and peripheral adaptations promoting an enhanced availability, extraction, and utilization of oxygen [7,8]. Although these findings are encouraging, these previous studies have tended to prescribe exercise with a focus on cycling and running [9][10][11][12]. Some argue that the psychologically aversive nature of high-intensity exercise means that this training will not be adopted or maintained by many people [13]. Thus, although the physiological benefits of HIT are unequivocal, there is ongoing debate about its relevance across populations, particularly for those less-motivated individuals. Finding ways to improve its acceptability could be the key to improve the wider acceptance of HIT.". "A major challenge with improving HIT and exergaming is to translate positive laboratory-based findings into interventions that can directly affect those individuals who need it most and can also be administered on a larger scale [16,17]. Whether or not the concept of serious exergaming can contribute in this regard requires, first, that a game is tailored toward reducing the aversive protocols associated with HIT and second, that the intervention is capable of improving fitness in our target population". "A major challenge with improving HIT and exergaming is to translate positive laboratory-based findings into interventions that can directly affect those individuals who need it most and can also be administered on a larger scale [16,17]. Whether or not the concept of serious exergaming can contribute in this regard requires, first, that a game is tailored toward reducing the aversive protocols associated with HIT and second, that the intervention is capable of improving fitness in our target population". METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Yes. "our first aim was to describe the development of a serious exergame for this purpose. Our second aim was to quantify its real-world fidelity and potential to improve fitness and health outcomes in males recruited in regions of socioeconomic deprivation over a 6-week intervention." 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants Yes. "We conducted a 6-week exploratory controlled trial". "A third-party minimization process using baseline measures of age, waist circumference, and predicted maximum oxygen consumption (VO2 max) was used to remove bias in group allocation." 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: N/A 4a-iii) Information giving during recruitment Yes. "Men are commonly referred to as a hard-to-reach population to engage in health promotion activities [27], where a targeted recruitment approach at locations predominantly attended by men may facilitate uptake of participants. Therefore, to maximize recruitment within our intended population, relevant gatekeepers were approached at institutions positioned within regions of social deprivation. Thus, two settings used for recruitment and the trials were a social club and mosque, both situated within deprived regions of Middlesbrough, United Kingdom (TS1 and TS4). Recruitment in the social club relied heavily on the gatekeeper (club secretary), whereas uptake of South Asian men from a local mosque was more straightforward; all 9 mosque participants were recruited from a single demonstration (and we had similar experiences in previous iterations)." 4b) CONSORT: Settings and locations where the data were collected N/A. There were no changes to the trial after commencement 4b-i) Report if outcomes were (self-)assessed through online questionnaires 4b-ii) Report how institutional affiliations are displayed N/A. Health outcomes were assessed in-person by a member of the research team [TM]. 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5-ii) Describe the history/development process N/A 5-iii) Revisions and updating
Yes. The paper has sub-section titled "Development of the Game and Intervention" where in-depth details are provided regarding focus groups and software/hardware development for the trial. 5-iv) Quality assurance methods N/A. No revisions or updates were made to the trail, software and hardware after commencement. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used N/A 5-vi) Digital preservation Yes. A flowchart for the machine state variables used for delivering a HIT dose are provided in a figure within the text. Furthermore, details about the development of the software are provided in the manuscript.

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Yes. Allocation to groups was randomized and is highlighted in figure 4 (participant flow). "two settings used for recruitment and the trials were a social club and mosque". Participants allocated to the intervention group were able to play the exergame during the 6-week period.

5-ix) Describe use parameters
Yes. A sub-section of the method section is titled "Intervention Delivery"; Evidence recommends a minimum duration of 12 weeks for a HIT protocol to promote favorable changes in blood pressure and anthropometric measurements of obesity [35]. However, a 6-week intervention was selected, as a minimum of 13 sessions (0.16 work/rest ratio) is sufficient to elicit moderate improvements in VO2 max in sedentary individuals [5]. Additionally, there is still ambiguity regarding the optimal work-to-rest ratio when designing HIT interventions, particularly in populations with varied age, baseline fitness, and training experience [36]. Therefore, longer duration HIT models (1-4 min) were deemed unsuitable for our target population [37]. Furthermore, minigames (such as the current exergame) have short life spans, where adherence to a longer intervention (eg, 12 weeks) may diminish over time and influence health outcomes. This was evident from a 12-week pilot study (unpublished data) using an exergame in the same population that saw attendance drop from 53% during week 2 to 16% during week 12. At the beginning of the exergaming session, participants were required to complete a 6-min structured warm-up consisting of a series of exercises on a 210 mm step until both participants reached >70% HRmax. Session workloads with volumetric progression were set automatically once the user's identifying information was entered. The session workloads were 120s-, 150-s, and 180-s of work during weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6, respectively. To avoid staleness, the repetition lengths (10, 20, or 30-s) were randomly selected at the beginning of each round. We set the work-to-rest ratio at 1:4, and thus, the respective repetitions were followed by 40, 80, or 120-s of active recovery. Each exergaming session took approximately 30 to 40 min to complete, including equipment set-up, warm-up with additional enjoyment, and task immersion questionnaires upon completion of the HIT bouts (not reported here). Heart rate responses were taken within repetitions and therefore, did not include any of the recovery period. This, therefore, avoided an overestimation of physiological load, which can occur when heart rate continues to rise after exercise cessation [26].". "To explore perceptions of the exergame and the HIT regime, semistructured interviews were conducted with 5 intervention participants following the 6-week training period, which were analyzed semantically." 5-x) Clarify the level of human involvement "Participants allocated to the intervention group were invited to attend three sessions of exergaming per week". "At the beginning of the exergaming session, participants were required to complete a 6-min structured warm-up consisting of a series of exercises on a 210 mm step" 5-xi) Report any prompts/reminders used No. Although this is not mentioned in the paper, a member of the research team [TM] was responsible for setting up the equipment and running the HIT sessions.

5-xii) Describe any co-interventions (incl. training/support)
No. Regular contact was made by a member of the research team [TM] to organize training sessions. 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Yes. "Inclusion criteria were deliberately broad to maximize recruitment, that is, apparently healthy, as defined by ACSM guidelines and in the age range of 18 to 55 years" 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored N/A 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Yes. Heart rate was collected during the trails and specified "two wireless chest-worn heart-rate monitors (Polar RS400, Polar Electro Oy, Kempele, Finland).". ""Participants were instructed to perform the repetitions at an intensity ≥85% HRmax"" 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Yes. "two settings used for recruitment and the trials were a social club and mosque, both situated within deprived regions of Middlesbrough, United Kingdom (TS1 and TS4)" 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines Yes. "All measures were assessed pre and post intervention. Blood pressure was collected on the left arm positioned at heart height with the subjects in a seated position by an automatic upper arm blood pressure monitor (Omron MX13). Measures were made at least three times at 3-min intervals, where an average of the two lowest measures was used for analysis [31]. Waist circumference was measured using the World Health Organization guidelines [32]. Predicted VO2 max was obtained by performing a submaximal 8-min ramped step test [33]. Heart rate response (Polar T34; PolarElectro OY, Kempele, Finland) and simultaneous breath-by-breath expired gas were collected using a portable indirect calorimeter (Cosmed K4 b2; Rome, Italy), calibrated per the manufacturer's guidelines. Individual HRmax was estimated [34] and plotted against VO2 data for the determination of predicted VO2 max.". "Body mass index [29] and waist circumference [30] cut-points were adjusted for ethnicity." 8a) CONSORT: Method used to generate the random allocation sequence N/A 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) N/A 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Yes. "A third-party minimization process using baseline measures of age, waist circumference, and predicted maximum oxygen consumption (VO2 max) was used to remove bias in group allocation." 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Yes. "A third-party minimization process using baseline measures of age, waist circumference, and predicted maximum oxygen consumption (VO2 max) was used to remove bias in group allocation." 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" N/A 11b) CONSORT: If relevant, description of the similarity of interventions Yes. "A third-party minimization process using baseline measures of age, waist circumference, and predicted maximum oxygen consumption (VO2 max) was used to remove bias in group allocation." 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes No 12a-i) Imputation techniques to deal with attrition / missing values