NCT03477773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 13, 2018

Last Update Submit

March 19, 2018

Conditions

Metabolic Syndrome

Keywords

high-intensity interval trainingvideo gamesheart rateboxingmetabolic syndrome

Outcome Measures

Primary Outcomes (4)

  • 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).

    Six-weeks

  • 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).

    Six-weeks

  • Waist circumference

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

    Six-weeks

  • Body Mass

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

    Six-weeks

Secondary Outcomes (2)

  • Within-participant heart rate

    Six-weeks

  • Between-participant heart rate

    Six-weeks

Other Outcomes (1)

  • Perceptions of the high-intensity exergame

    Six-weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: High-intensity exergaming

Control

NO INTERVENTION

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

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 'apparently healthy' according the ACSM guidelines

You may not qualify if:

  • known presence of cardiovascular disease
  • musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, S102BP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29588271DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Pilot, exploratory, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 26, 2018

Study Start

November 1, 2014

Primary Completion

April 30, 2015

Study Completion

April 30, 2015

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD from the current study.

Locations

GB(1)