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Metabolic SyndromeNCT03477773

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

A study testing High-intensity exergaming in people with Metabolic Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
High-intensity exergaming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2014to 30 Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 'apparently healthy' according the ACSM guidelines

Who cannot join

  • known presence of cardiovascular disease
  • musculoskeletal injury

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Sheffield Hallam University

    Sheffield, South Yorkshire, S102BP

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
High-intensity exergaming
Keywords
high-intensity interval training, video games, heart rate, boxing, metabolic syndrome
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity exergamingOther

    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.

Study groups in NCT03477773
Study groupRoleWhat they receive
InterventionExperimentalPerform three session of high-intensity, interval training sessions per week over the 6-week intervention
Receives: Other: High-intensity exergaming
ControlNo interventionContinue with their normal habitual lifestyle over the 6-week intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory fitness

    Predicted VO2max was obtained by performing a submaximal 8-min ramped step test. 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 and plotted against VO2 data for the determination of predicted VO2max (reported in ml.kg.min-1).

    Measured: Six-weeks

  2. Blood pressure

    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 (reported in mm/Hg).

    Measured: Six-weeks

  3. Waist circumference

    Waist circumference was measured using the World Health Organization guidelines (reported in cm).

    Measured: Six-weeks

  4. Body Mass

    Body mass was measured using a portable set of electronic scales (Seca, Birmingham, UK) and reported the neasrest 0.1kg.

    Measured: Six-weeks

Secondary outcomes (2)
  1. Within-participant heart rate

    To observe the within-participant heart rate responses to the 10, 20 and 30s high-intensity repetitions across the intervention (reported as percentage of individual heart rate maximum (%).

    Measured: Six-weeks

  2. Between-participant heart rate

    To observe the between-participant heart rate responses to the 10, 20 and 30s high-intensity repetitions across the intervention (reported as percentage of individual heart rate maximum (%).

    Measured: Six-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2018
  2. Study start1 Nov 2014
  3. Primary completion30 Apr 2015
  4. Study completion30 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot, exploratory, randomized controlled trial
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477773
Sponsor's protocol ID
SheffieldHU
Status last verified
Mar 2018
First submitted
13 Mar 2018
Last updated
26 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share IPD from the current study.

Publications

  • 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.

    PubMed 29588271

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity exergaming in people with Metabolic Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory fitness (time frame: Six-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03477773, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.

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