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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-intensity exergaming
Sponsored by
Sheffield Hallam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring high-intensity interval training, video games, heart rate, boxing, metabolic syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 'apparently healthy' according the ACSM guidelines

Exclusion Criteria:

  • known presence of cardiovascular disease
  • musculoskeletal injury

Sites / Locations

  • Sheffield Hallam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
Waist circumference
Waist circumference was measured using the World Health Organization guidelines (reported in cm).
Body Mass
Body mass was measured using a portable set of electronic scales (Seca, Birmingham, UK) and reported the neasrest 0.1kg.

Secondary Outcome Measures

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 (%).
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 (%).

Full Information

First Posted
March 13, 2018
Last Updated
March 19, 2018
Sponsor
Sheffield Hallam University
Collaborators
Teesside University, Northumbria University, Newcastle University
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1. Study Identification

Unique Protocol Identification Number
NCT03477773
Brief Title
Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training
Official Title
Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training: Formative Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheffield Hallam University
Collaborators
Teesside University, Northumbria University, Newcastle University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
high-intensity interval training, video games, heart rate, boxing, metabolic syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, exploratory, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Perform three session of high-intensity, interval training sessions per week over the 6-week intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continue with their normal habitual lifestyle over the 6-week intervention
Intervention Type
Other
Intervention Name(s)
High-intensity exergaming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
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).
Time Frame
Six-weeks
Title
Blood pressure
Description
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).
Time Frame
Six-weeks
Title
Waist circumference
Description
Waist circumference was measured using the World Health Organization guidelines (reported in cm).
Time Frame
Six-weeks
Title
Body Mass
Description
Body mass was measured using a portable set of electronic scales (Seca, Birmingham, UK) and reported the neasrest 0.1kg.
Time Frame
Six-weeks
Secondary Outcome Measure Information:
Title
Within-participant heart rate
Description
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 (%).
Time Frame
Six-weeks
Title
Between-participant heart rate
Description
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 (%).
Time Frame
Six-weeks
Other Pre-specified Outcome Measures:
Title
Perceptions of the high-intensity exergame
Description
Semistructured interviews were conducted with intervention participants following the 6-week training period to explore the feasability of the intervention and developed exergame
Time Frame
Six-weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 'apparently healthy' according the ACSM guidelines Exclusion Criteria: known presence of cardiovascular disease musculoskeletal injury
Facility Information:
Facility Name
Sheffield Hallam University
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S102BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD from the current study.
Citations:
PubMed Identifier
29588271
Citation
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.
Results Reference
derived

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

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