NCT04633590

Brief Summary

Current guidelines recommend that adults undertake at least 150 minutes of moderate intensity physical activity or 75 minutes of vigorous physical activity per week. However, many adults fail to be physically active according to this definition of the World Health Organisation (WHO). This represents a large economic burden to healthcare systems and public health. A number of behavioural and environmental factors associated with modern lifestyles are largely responsible for the high levels of physical inactivity including; motorised transport and sedentary jobs, lack of time, limited access to adequate exercise facilities, lack of motivation, financial constraints and environmental factors including bad weather. In an attempt to overcome many of the common barriers to exercise, members of our research group developed a virtually-monitored exercise intervention that used simple on-the-spot bodyweight exercises to be performed in the participant's home without supervision or equipment. This home-based intervention was designed to be a practical and effective training strategy capable of producing metabolic and functional adaptions while removing many of the common barriers to exercise. Despite promising results, more engaging exercise strategies are needed to motivate sedentary individuals to increase their physical activity. Inspired by current trends in the fitness market, Sphery Ltd. developed an immersive and motivating fitness exercise game (exergame), the "ExerCube". The ExerCube allows a full-body workout that concurrently challenges physical and cognitive functions and adapts to the fitness and skill level of the individual. The development of a home-based version of the ExerCube has the potential to make this system available to more individuals, reduce major barriers to exercise, and ultimately provide a strategy to improve cardio-metabolic health in the population. Innovative home-based exergames are particularly in demand given the increase in the number of people wanting to exercise at home due to the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

November 10, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

November 10, 2020

Last Update Submit

March 13, 2023

Conditions

Keywords

Home-based exercise gamingCardiovascular healthNeurocognitive healthPhysical InactivityExergame

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Change in maximal aerobic capacity (VO2max)

    Pre to post 6 weeks of home-based exergame training

Secondary Outcomes (25)

  • Wmax

    Pre to post 6 weeks of home-based exergame training

  • Adherence

    6 weeks of home-based exergame training

  • Adherence

    6 weeks of training

  • Drop-out rate

    6 weeks training

  • Physical Activity Enjoyment Scale (PACES) score

    Pre to post 6 weeks of home-based exergame training

  • +20 more secondary outcomes

Study Arms (1)

home-based exergaming

EXPERIMENTAL

The home-based exergame intervention will take place in an unsupervised place of the participant's choosing. Participants will be provided with all of the equipment (including a television if required) and receive instructions on how to use the system. Participants will be provided with a stepped training plan with exergame session durations of 19 minutes (4x 3-minutes 45-seconds of exercise interspersed with 1 minute of rest) in weeks 1 and 2; 24-minutes (4x 5-minutes of exercise interspersed with 1 minute of rest) in week 3 and 4; and 30-minutes (5x 5-minutes of exercise interspersed with 1 minute of rest) in week 5 and 6. Sessions will be set at a vigorous intensity (≥80% heart rate maximum) and participants will be provided with individualised heart rate zones to achieve in line with heart rate maximum determined during a maximal exercise test in Visit 2. Participants will be asked to train 3 times per week.

Behavioral: Home-based exergaming

Interventions

Participants will undertake one of two 6-week training interventions. In both groups participants will be asked to train 3 times per week (18 sessions total), during which adherence to the training will be measured. To monitor adherence to training and training load (exercise completion, exercise duration and heart rate achieved during workouts) throughout the 6 weeks participants will be given a heart rate monitor.

home-based exergaming

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged 18-55
  • Physically inactive, defined as not meeting the exercise guidelines of 150 minutes of moderate physical activity or 75 minutes of vigorous physical activity per week
  • BMI 18.5 kg/m2 - 30 kg/m2
  • No known cardiovascular disorders
  • Able to provide written informed consent and understand instructions

You may not qualify if:

  • Overt diabetes mellitus (type 1, type 2, other forms of diabetes)
  • Pregnant, planning on becoming pregnant during the study, or breast feeding
  • Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

Location

Related Publications (23)

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    PMID: 32342452BACKGROUND
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    PMID: 23798298BACKGROUND
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    PMID: 33239350BACKGROUND
  • Chtourou H, Trabelsi K, H'mida C, Boukhris O, Glenn JM, Brach M, Bentlage E, Bott N, Shephard RJ, Ammar A, Bragazzi NL. Staying Physically Active During the Quarantine and Self-Isolation Period for Controlling and Mitigating the COVID-19 Pandemic: A Systematic Overview of the Literature. Front Psychol. 2020 Aug 19;11:1708. doi: 10.3389/fpsyg.2020.01708. eCollection 2020.

    PMID: 33013497BACKGROUND
  • Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.

    PMID: 27475266BACKGROUND
  • Donath L, Roth R, Hurlimann C, Zahner L, Faude O. Pilates vs. Balance Training in Health Community-Dwelling Seniors: a 3-arm, Randomized Controlled Trial. Int J Sports Med. 2016 Mar;37(3):202-10. doi: 10.1055/s-0035-1559695. Epub 2015 Dec 2.

    PMID: 26630547BACKGROUND
  • Franklin BA, Bonzheim K, Gordon S, Timmis GC. Safety of medically supervised outpatient cardiac rehabilitation exercise therapy: a 16-year follow-up. Chest. 1998 Sep;114(3):902-6. doi: 10.1378/chest.114.3.902. No abstract available.

    PMID: 9743182BACKGROUND
  • Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. doi: 10.1161/01.cir.0000034670.06526.15. No abstract available.

    PMID: 12356646BACKGROUND
  • Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD Jr, Winters WL, Yanowitz FG, Ritchie JL, Gibbons RJ, Cheitlin MD, Eagle KA, Gardner TJ, Garson A Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA Guidelines for Exercise Testing. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). J Am Coll Cardiol. 1997 Jul;30(1):260-311. doi: 10.1016/s0735-1097(97)00150-2. No abstract available.

    PMID: 9207652BACKGROUND
  • Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.

    PMID: 30193830BACKGROUND
  • Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U; Lancet Physical Activity Series Working Group. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012 Jul 21;380(9838):247-57. doi: 10.1016/S0140-6736(12)60646-1.

    PMID: 22818937BACKGROUND
  • Jekauc D, Nigg C, Nigg CR, Reichert M, Krell-Roesch J, Oriwol D, Schmidt S, Wunsch K, Woll A. Measurement properties of the German version of the Physical Activity Enjoyment Scale for adults. PLoS One. 2020 Nov 18;15(11):e0242069. doi: 10.1371/journal.pone.0242069. eCollection 2020.

    PMID: 33206685BACKGROUND
  • Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.

    PMID: 22818941BACKGROUND
  • Morgan F, Battersby A, Weightman AL, Searchfield L, Turley R, Morgan H, Jagroo J, Ellis S. Adherence to exercise referral schemes by participants - what do providers and commissioners need to know? A systematic review of barriers and facilitators. BMC Public Health. 2016 Mar 5;16:227. doi: 10.1186/s12889-016-2882-7.

    PMID: 26944952BACKGROUND
  • Motl RW, Dishman RK, Saunders R, Dowda M, Felton G, Pate RR. Measuring enjoyment of physical activity in adolescent girls. Am J Prev Med. 2001 Aug;21(2):110-7. doi: 10.1016/s0749-3797(01)00326-9.

    PMID: 11457630BACKGROUND
  • Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. doi: 10.1161/01.cir.0000048890.59383.8d. No abstract available.

    PMID: 12515760BACKGROUND
  • Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801. doi: 10.1056/NEJMoa011858.

    PMID: 11893790BACKGROUND
  • Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.

    PMID: 21509114BACKGROUND
  • Scott SN, Shepherd SO, Andrews RC, Narendran P, Purewal TS, Kinnafick F, Cuthbertson DJ, Atkinson-Goulding S, Noon T, Wagenmakers AJM, Cocks M. A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. Diabetes Care. 2019 Dec;42(12):2330-2333. doi: 10.2337/dc19-0871. Epub 2019 Sep 17.

    PMID: 31530660BACKGROUND
  • Scott SN, Shepherd SO, Hopkins N, Dawson EA, Strauss JA, Wright DJ, Cooper RG, Kumar P, Wagenmakers AJM, Cocks M. Home-hit improves muscle capillarisation and eNOS/NAD(P)Hoxidase protein ratio in obese individuals with elevated cardiovascular disease risk. J Physiol. 2019 Aug;597(16):4203-4225. doi: 10.1113/JP278062. Epub 2019 Jul 15.

    PMID: 31218680BACKGROUND
  • Shepherd SO, Cocks M, Tipton KD, Ranasinghe AM, Barker TA, Burniston JG, Wagenmakers AJ, Shaw CS. Sprint interval and traditional endurance training increase net intramuscular triglyceride breakdown and expression of perilipin 2 and 5. J Physiol. 2013 Feb 1;591(3):657-75. doi: 10.1113/jphysiol.2012.240952. Epub 2012 Nov 5.

    PMID: 23129790BACKGROUND
  • Tari AR, Nauman J, Zisko N, Skjellegrind HK, Bosnes I, Bergh S, Stensvold D, Selbaek G, Wisloff U. Temporal changes in cardiorespiratory fitness and risk of dementia incidence and mortality: a population-based prospective cohort study. Lancet Public Health. 2019 Nov;4(11):e565-e574. doi: 10.1016/S2468-2667(19)30183-5.

    PMID: 31677775BACKGROUND
  • Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.

    PMID: 12471307BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christoph Stettler, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A single-centre, single-armed, open label pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 18, 2020

Study Start

March 23, 2022

Primary Completion

January 23, 2023

Study Completion

January 23, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations