Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 45962 for:    intensity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477773
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Teesside University
Northumbria University
Newcastle University
Information provided by (Responsible Party):
Tom McBain, Sheffield Hallam University

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: High-intensity exergaming Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot, exploratory, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training: Formative Pilot Randomized Trial
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : April 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Perform three session of high-intensity, interval training sessions per week over the 6-week intervention
Other: 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.

No Intervention: Control
Continue with their normal habitual lifestyle over the 6-week intervention



Primary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: Six-weeks ]
    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).

  2. Blood pressure [ Time Frame: Six-weeks ]
    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).

  3. Waist circumference [ Time Frame: Six-weeks ]
    Waist circumference was measured using the World Health Organization guidelines (reported in cm).

  4. Body Mass [ Time Frame: Six-weeks ]
    Body mass was measured using a portable set of electronic scales (Seca, Birmingham, UK) and reported the neasrest 0.1kg.


Secondary Outcome Measures :
  1. Within-participant heart rate [ Time Frame: Six-weeks ]
    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 (%).

  2. Between-participant heart rate [ Time Frame: Six-weeks ]
    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 (%).


Other Outcome Measures:
  1. Perceptions of the high-intensity exergame [ Time Frame: Six-weeks ]
    Semistructured interviews were conducted with intervention participants following the 6-week training period to explore the feasability of the intervention and developed exergame



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 'apparently healthy' according the ACSM guidelines

Exclusion Criteria:

  • known presence of cardiovascular disease
  • musculoskeletal injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477773


Locations
Layout table for location information
United Kingdom
Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S102BP
Sponsors and Collaborators
Sheffield Hallam University
Teesside University
Northumbria University
Newcastle University
  Study Documents (Full-Text)

Documents provided by Tom McBain, Sheffield Hallam University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tom McBain, Principal Investigator, Sheffield Hallam University
ClinicalTrials.gov Identifier: NCT03477773     History of Changes
Other Study ID Numbers: SheffieldHU
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD from the current study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tom McBain, Sheffield Hallam University:
high-intensity interval training
video games
heart rate
boxing
metabolic syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases