Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training

NCT ID: NCT03477773

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2015-04-30

Brief Summary

Males from areas of social deprivation within the town of Middlesbrough (UK) were targetted and recruited on to a high-intensity, exergaming intervention over a 6-week period. Eligible participants were randomly allocated to an intervention group (weekly exergaming) or control group (normal habitual lifestyle). All participants completed baseline (week 0) and follow-up (week 7) measures of metabolic health. Participants in the intervention group were invited to three sessions a week of high-intensity exergaming performed against their peers on a developed boxing game.

Detailed Description

A 6-week exploratory controlled trial designed to assess the fidelity of the game in terms of delivering the intended training stimulus and to examine the effect of the intervention on selected health outcomes was conducted. As appropriate for an exploratory trial, the investigators did not conduct formal sample size estimation a priori, rather the CIs would be used to inform future trials. A targeted recruitment approach at locations predominantly attended by men may facilitate uptake of participants was used. Therefore, to maximize recruitment within the 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). A total of 24 males were recruited into the trial (Figure 4) using relevant gatekeepers at institutions positioned within regions of social deprivation. Two recruitment drives (October 2014 and February 2015) took place, and these involved live demonstrations of the technology followed by word-of-mouth and snowballing approaches. The exergaming system was important in this recruitment process because it provided something tangible and interesting to engage potential participants.

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. The control group was instructed to maintain their current physical activity levels and inform the researchers should any changes arise during the intervention period. Overall retention to the intervention that encompassed baseline and follow-up measures was 87.5% (21/24).

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. The study was approved by the ethics committee of Teesside University, United Kingdom, and written informed consent was obtained from all participants.

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. 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. Therefore, longer duration HIT models (1-4 min) were deemed unsuitable for the target population. 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.

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 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 120-s, 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. The investigators 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. Participants were instructed to perform the repetitions at an intensity ≥85% HRmax. 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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

Perform three session of high-intensity, interval training sessions per week over the 6-week intervention

Group Type: EXPERIMENTAL

High-intensity exergaming

Intervention Type: OTHER

Perform high-intensity exercise whilst playing a developed exergame. A full warm-up performed prior to the session was performed (\~70% HRmax). Periods of exercise were performed at an intensity \>85% HRmax for periods of 10, 20 and 30s, interspersed with periods of rest, for a total of 2-3 minutes per session. Heart rate was monitored throughout the intervention.

Control

Continue with their normal habitual lifestyle over the 6-week intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High-intensity exergaming

Perform high-intensity exercise whilst playing a developed exergame. A full warm-up performed prior to the session was performed (\~70% HRmax). Periods of exercise were performed at an intensity \>85% HRmax for periods of 10, 20 and 30s, interspersed with periods of rest, for a total of 2-3 minutes per session. Heart rate was monitored throughout the intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 'apparently healthy' according the ACSM guidelines

Exclusion Criteria

• known presence of cardiovascular disease
• musculoskeletal injury

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teesside University

OTHER

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: lead

Responsible Party

Tom McBain

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

McBain T, Weston M, Crawshaw P, Haighton C, Spears I. Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training: Formative Pilot Randomized Trial. JMIR Serious Games. 2018 Mar 27;6(1):e4. doi: 10.2196/games.7758.

Reference Type: DERIVED

PMID: 29588271 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SheffieldHU

Identifier Type: -

Identifier Source: org_study_id