NCT04112329

Brief Summary

The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity, aerobic fitness and health benefits in sedentary adults. The project will include 28 sedentary adults, 18 years and above, who are not sufficiently active according to current guidelines defined as doing (\<150 minutes/week of moderate intensity physical activity or \<75 minutes/week of vigorous physical activity and/or do not do any regular endurance training ). The physical fitness (maximal oxygen consumption), blood pressure, body composition and objectively measured physical activity will be tested before and after the intervention period. Also, the participants gaming frequency will be registered throughout the 8 week period. Aim of this study is to investigate if access to this game can provide health benefits for adults who are not motivated to take part in regular physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

September 30, 2019

Last Update Submit

May 11, 2021

Conditions

Keywords

Exercise therapyPhysical fitnessGamingChildHealthy lifestyleFitness testing

Outcome Measures

Primary Outcomes (1)

  • VO2max (Maximal Aerobic Capacity)

    8 weeks

Secondary Outcomes (9)

  • Daily average energy expenditure

    8 weeks

  • Daily average number of steps

    8 weeks

  • Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)

    8 weeks

  • Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)

    8 weeks

  • Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Exergaming

EXPERIMENTAL

Will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks

Behavioral: Exergaming

Control

NO INTERVENTION

Asked to continue with their normal daily routine

Interventions

ExergamingBEHAVIORAL

will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks.

Exergaming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary (\<150 mins of moderate intensity physical activity/week) and/or do not regularly take part in endurance training.
  • Able to ride a bike for up to 60 minutes

You may not qualify if:

  • Known cardiovascular disease
  • Taking beta-blockers or anti-arrhythmic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, 7491, Norway

Location

Related Publications (1)

  • Berg J, Haugen G, Wang AI, Moholdt T. High-intensity exergaming for improved cardiorespiratory fitness: A randomised, controlled trial. Eur J Sport Sci. 2022 Jun;22(6):867-876. doi: 10.1080/17461391.2021.1921852. Epub 2021 May 16.

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa

    Norwegian University of Science and Technology

    STUDY DIRECTOR
  • Trine Moholdt, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

October 14, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations