NCT05839262

Brief Summary

Population aging is currently an issue of primary relevance, constituting an enormous challenge for institutions and society. On the other hand, osteoarthritis (OA) is the most prevalent arthropathy in the elderly, strongly related to loss of functional capacity, limitation of daily activities, increased musculoskeletal pain, and deterioration of quality of life. More specifically, knee and hip OA represent a significant burden for health systems, and in Chile, they are among the ten most frequent diseases in the elderly. The technological development of the last decades has allowed the incorporation of several therapeutic alternatives for the intervention of the elderly, such as virtual reality, which allows interaction with multiple digital environments. Active video games (AVG) or exergames, carried out through commercial non-immersive virtual reality systems, have been proposed as a feasible, innovative, and entertaining alternative to optimize conventional physical rehabilitation (CPR). AVG in healthy older people and those with neurocognitive conditions effectively improves clinical and psychosocial outcomes. However, it has been recommended to advance the study of the effects of AVGs in people with musculoskeletal pathologies, such as knee and hip OA. Accordingly, the purpose is to analyze the effects of an AVG-guided physical exercise protocol adjunct to CPR on functional mobility in older adults with knee and/or hip OA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

March 15, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

April 4, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 15, 2023

Last Update Submit

March 17, 2025

Conditions

Keywords

osteoarhrosiselderlyexercise trainingvideo gamespublic health

Outcome Measures

Primary Outcomes (1)

  • Change in Functional mobility.

    Timed Up and Go (TUG). Number of seconds required to get up from seated position, walk 3 m, turn, and return to seated position on chair.

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

Secondary Outcomes (14)

  • Change in Lower body strength.

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

  • Change in Upper body strength.

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

  • Change in Aerobic endurance.

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

  • Change in Lower body flexibility

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

  • Change in Upper body flexibility.

    Five-time points. Baseline (pre-intervention); at week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.

  • +9 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Conventional physical rehabilitation plus Active video games (CPR+AVG)

Other: Conventional physical rehabilitation plus Active video games (CPR+AVG)

Control group

ACTIVE COMPARATOR

Conventional physical rehabilitation alone (CPR)

Other: Conventional physical rehabilitation alone (CPR)

Interventions

In each session a routine of conventional physical rehabilitation and active video games is performed. The duration is 10 weeks / 3 sessions per week (30 sessions). CPR+AVG: Consists of conventional exercises (aerobic, muscle strengthening, postural balance and flexibility) added to a set of interactive video games available for the Nintendo Switch console.

Experimental group

In each session a routine of conventional exercises is performed. The duration is 10 weeks / 3 sessions per week (30 sessions). CPR: Conventional exercises (aerobic, muscle strengthening, postural balance and flexibility).

Control group

Eligibility Criteria

Age60 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60 and ≤84 years.
  • Diagnosis of mild or moderate OA of the knee and/or hip.
  • Independent walking capacity of at least 15 meters.

You may not qualify if:

  • Inability to interact with active video games.
  • Undergoing treatment with opioids or other medications with a potential influence on the outcomes of interest.
  • \<13 points in the abbreviated version of the Mini-Mental State Examination (MMSE-EFAM).
  • OA associated with infectious, autoimmune, fractures or surgery.
  • Participate or have participated in another physical-cognitive rehabilitation program during the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud Familiar (CESFAM) Lorenzo Arenas

Concepción, Chile

Location

Related Publications (36)

  • Spitaels D, Mamouris P, Vaes B, Smeets M, Luyten F, Hermens R, Vankrunkelsven P. Epidemiology of knee osteoarthritis in general practice: a registry-based study. BMJ Open. 2020 Jan 20;10(1):e031734. doi: 10.1136/bmjopen-2019-031734.

    PMID: 31964664BACKGROUND
  • Rosen J, Niazi F, Dysart S. Cost-Effectiveness of Treating Early to Moderate Stage Knee Osteoarthritis with Intra-articular Hyaluronic Acid Compared to Conservative Interventions. Adv Ther. 2020 Jan;37(1):344-352. doi: 10.1007/s12325-019-01142-x. Epub 2019 Nov 18.

    PMID: 31735982BACKGROUND
  • Ho KW, Pong G, Poon WC, Chung KY, Kwok YY, Chiu KH. Progression of health-related quality of life of patients waiting for total knee arthroplasty. J Eval Clin Pract. 2021 Feb;27(1):69-74. doi: 10.1111/jep.13388. Epub 2020 Mar 22.

    PMID: 32202045BACKGROUND
  • Mat S, Ng CT, Tan MP. Influence of hip and knee osteoarthritis on dynamic postural control parameters among older fallers. J Rehabil Med. 2017 Mar 6;49(3):258-263. doi: 10.2340/16501977-2202.

    PMID: 28218341BACKGROUND
  • Manlapaz DG, Sole G, Jayakaran P, Chapple CM. Risk Factors for Falls in Adults with Knee Osteoarthritis: A Systematic Review. PM R. 2019 Jul;11(7):745-757. doi: 10.1002/pmrj.12066. Epub 2019 Mar 28.

    PMID: 30609282BACKGROUND
  • Hurley M, Dickson K, Hallett R, Grant R, Hauari H, Walsh N, Stansfield C, Oliver S. Exercise interventions and patient beliefs for people with hip, knee or hip and knee osteoarthritis: a mixed methods review. Cochrane Database Syst Rev. 2018 Apr 17;4(4):CD010842. doi: 10.1002/14651858.CD010842.pub2.

    PMID: 29664187BACKGROUND
  • Klaps S, Haesevoets S, Verbunt J, Koke A, Janssens L, Timmermans A, Verbrugghe J. The Influence of Exercise Intensity on Psychosocial Outcomes in Musculoskeletal Disorders: A Systematic Review. Sports Health. 2022 Nov-Dec;14(6):859-874. doi: 10.1177/19417381221075354. Epub 2022 Mar 4.

    PMID: 35243924BACKGROUND
  • Hawley-Hague H, Horne M, Skelton DA, Todd C. Review of how we should define (and measure) adherence in studies examining older adults' participation in exercise classes. BMJ Open. 2016 Jun 23;6(6):e011560. doi: 10.1136/bmjopen-2016-011560.

    PMID: 27338884BACKGROUND
  • Room J, Hannink E, Dawes H, Barker K. What interventions are used to improve exercise adherence in older people and what behavioural techniques are they based on? A systematic review. BMJ Open. 2017 Dec 14;7(12):e019221. doi: 10.1136/bmjopen-2017-019221.

    PMID: 29247111BACKGROUND
  • Franco MR, Tong A, Howard K, Sherrington C, Ferreira PH, Pinto RZ, Ferreira ML. Older people's perspectives on participation in physical activity: a systematic review and thematic synthesis of qualitative literature. Br J Sports Med. 2015 Oct;49(19):1268-76. doi: 10.1136/bjsports-2014-094015. Epub 2015 Jan 13.

    PMID: 25586911BACKGROUND
  • Cigarroa I, Zapata-Lamana R, Leiva-Gajardo G, Vasquez E, Parrado-Romero E, Vásquez-Gomez J, et al. Adherence characteristics and reasons for abandonment of physical exercise-based interventions in older adults in Latin America: A scoping review (Características de la adherencia y motivos del abandono de las intervenciones basadas en el ejercicio físic. Retos. 2022 Apr 1;44:10-26.

    BACKGROUND
  • Torner J, Skouras S, Molinuevo JL, Gispert JD, Alpiste F. Multipurpose Virtual Reality Environment for Biomedical and Health Applications. IEEE Trans Neural Syst Rehabil Eng. 2019 Aug;27(8):1511-1520. doi: 10.1109/TNSRE.2019.2926786. Epub 2019 Jul 4.

    PMID: 31283482BACKGROUND
  • Mirelman A, Maidan I, Shiratzky SS, Hausdorff JM. Virtual Reality Training as an Intervention to Reduce Falls. In: Montero-Odasso M, Camicioli R, editors. Falls and Cognition in Older Persons: Fundamentals, Assessment and Therapeutic Options. Cham: Springer International Publishing; 2020. p. 309-21.

    BACKGROUND
  • Marston HR, Smith ST. Interactive Videogame Technologies to Support Independence in the Elderly: A Narrative Review. Games Health J. 2012 Apr;1(2):139-52. doi: 10.1089/g4h.2011.0008.

    PMID: 26193189BACKGROUND
  • Zheng L, Li G, Wang X, Yin H, Jia Y, Leng M, Li H, Chen L. Effect of exergames on physical outcomes in frail elderly: a systematic review. Aging Clin Exp Res. 2020 Nov;32(11):2187-2200. doi: 10.1007/s40520-019-01344-x. Epub 2019 Sep 13.

    PMID: 31520334BACKGROUND
  • Kappen DL, Mirza-Babaei P, Nacke LE. Older Adults' Physical Activity and Exergames: A Systematic Review. International Journal of Human-Computer Interaction. 2019 Jan 20;35(2):140-67.

    BACKGROUND
  • Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.

    PMID: 23464951BACKGROUND
  • Tousignant M, Corriveau H, Roy PM, Desrosiers J, Dubuc N, Hebert R. Efficacy of supervised Tai Chi exercises versus conventional physical therapy exercises in fall prevention for frail older adults: a randomized controlled trial. Disabil Rehabil. 2013 Aug;35(17):1429-35. doi: 10.3109/09638288.2012.737084. Epub 2012 Nov 20.

    PMID: 23167499BACKGROUND
  • Li J, Erdt M, Chen L, Cao Y, Lee SQ, Theng YL. The Social Effects of Exergames on Older Adults: Systematic Review and Metric Analysis. J Med Internet Res. 2018 Jun 28;20(6):e10486. doi: 10.2196/10486.

    PMID: 29954727BACKGROUND
  • Collado-Mateo D, Merellano-Navarro E, Olivares PR, Garcia-Rubio J, Gusi N. Effect of exergames on musculoskeletal pain: A systematic review and meta-analysis. Scand J Med Sci Sports. 2018 Mar;28(3):760-771. doi: 10.1111/sms.12899. Epub 2017 May 22.

    PMID: 28452070BACKGROUND
  • Cacciata M, Stromberg A, Lee JA, Sorkin D, Lombardo D, Clancy S, Nyamathi A, Evangelista LS. Effect of exergaming on health-related quality of life in older adults: A systematic review. Int J Nurs Stud. 2019 May;93:30-40. doi: 10.1016/j.ijnurstu.2019.01.010. Epub 2019 Feb 10.

    PMID: 30861452BACKGROUND
  • Viana RB, de Oliveira VN, Dankel SJ, Loenneke JP, Abe T, da Silva WF, Morais NS, Vancini RL, Andrade MS, de Lira CAB. The effects of exergames on muscle strength: A systematic review and meta-analysis. Scand J Med Sci Sports. 2021 Aug;31(8):1592-1611. doi: 10.1111/sms.13964. Epub 2021 Apr 15.

    PMID: 33797115BACKGROUND
  • Bevilacqua R, Maranesi E, Riccardi GR, Donna VD, Pelliccioni P, Luzi R, Lattanzio F, Pelliccioni G. Non-Immersive Virtual Reality for Rehabilitation of the Older People: A Systematic Review into Efficacy and Effectiveness. J Clin Med. 2019 Nov 5;8(11):1882. doi: 10.3390/jcm8111882.

    PMID: 31694337BACKGROUND
  • Reis E, Postolache G, Teixeira L, Arriaga P, Lima ML, Postolache O. Exergames for motor rehabilitation in older adults: an umbrella review. Physical Therapy Reviews. 2019 Jul 4;24(3-4):84-99.

    BACKGROUND
  • Corregidor-Sanchez AI, Segura-Fragoso A, Rodriguez-Hernandez M, Criado-Alvarez JJ, Gonzalez-Gonzalez J, Polonio-Lopez B. Can exergames contribute to improving walking capacity in older adults? A systematic review and meta-analysis. Maturitas. 2020 Feb;132:40-48. doi: 10.1016/j.maturitas.2019.12.006. Epub 2019 Dec 9.

    PMID: 31883662BACKGROUND
  • Fang Q, Ghanouni P, Anderson SE, Touchett H, Shirley R, Fang F, Fang C. Effects of Exergaming on Balance of Healthy Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Games Health J. 2020 Feb;9(1):11-23. doi: 10.1089/g4h.2019.0016. Epub 2019 Dec 3.

    PMID: 31800322BACKGROUND
  • Ismail NA, Hashim HA, Ahmad Yusof H. Physical Activity and Exergames Among Older Adults: A Scoping Review. Games Health J. 2022 Feb;11(1):1-17. doi: 10.1089/g4h.2021.0104. Epub 2021 Dec 1.

    PMID: 34851732BACKGROUND
  • Janhunen M, Karner V, Katajapuu N, Niiranen O, Immonen J, Karvanen J, Heinonen A, Aartolahti E. Effectiveness of Exergame Intervention on Walking in Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2021 Sep 1;101(9):pzab152. doi: 10.1093/ptj/pzab152.

    PMID: 34160022BACKGROUND
  • Swinnen N, Vandenbulcke M, Vancampfort D. Exergames in people with major neurocognitive disorder: a systematic review. Disabil Rehabil Assist Technol. 2022 May;17(4):376-389. doi: 10.1080/17483107.2020.1785566. Epub 2020 Jul 22.

    PMID: 32697614BACKGROUND
  • Prosperini L, Tomassini V, Castelli L, Tacchino A, Brichetto G, Cattaneo D, Solaro CM. Exergames for balance dysfunction in neurological disability: a meta-analysis with meta-regression. J Neurol. 2021 Sep;268(9):3223-3237. doi: 10.1007/s00415-020-09918-w. Epub 2020 May 23.

    PMID: 32447551BACKGROUND
  • Wang B, Shen M, Wang YX, He ZW, Chi SQ, Yang ZH. Effect of virtual reality on balance and gait ability in patients with Parkinson's disease: a systematic review and meta-analysis. Clin Rehabil. 2019 Jul;33(7):1130-1138. doi: 10.1177/0269215519843174. Epub 2019 Apr 24.

    PMID: 31016994BACKGROUND
  • Zhao Y, Feng H, Wu X, Du Y, Yang X, Hu M, Ning H, Liao L, Chen H, Zhao Y. Effectiveness of Exergaming in Improving Cognitive and Physical Function in People With Mild Cognitive Impairment or Dementia: Systematic Review. JMIR Serious Games. 2020 Jun 30;8(2):e16841. doi: 10.2196/16841.

    PMID: 32602841BACKGROUND
  • Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639.

    PMID: 32823832BACKGROUND
  • Manlapaz DG, Sole G, Jayakaran P, Chapple CM. Exergaming to improve balance and decrease the risk of falling in adults with knee osteoarthritis: a mixed-methods feasibility study. Physiother Theory Pract. 2022 Nov;38(13):2428-2440. doi: 10.1080/09593985.2021.1952670. Epub 2021 Jul 19.

    PMID: 34280069BACKGROUND
  • Lin HT, Li YI, Hu WP, Huang CC, Du YC. A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. J Clin Med. 2019 Jun 4;8(6):791. doi: 10.3390/jcm8060791.

    PMID: 31167435BACKGROUND
  • Guede-Rojas F, Mendoza C, Rodriguez-Lagos L, Soto-Martinez A, Ulloa-Diaz D, Jorquera-Aguilera C, Carvajal-Parodi C. Effects of Non-Immersive Virtual Reality Exercise on Self-Reported Pain and Mechanical Hyperalgesia in Older Adults with Knee and Hip Osteoarthritis: A Secondary Analysis of a Randomized Controlled Trial. Medicina (Kaunas). 2025 Jun 21;61(7):1122. doi: 10.3390/medicina61071122.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cristhian Mendoza S., PhD

    Universidad San Sebastian

    STUDY CHAIR
  • Claudio Carvajal P., PhD

    Universidad San Sebastian

    STUDY DIRECTOR
  • Jorge Fuentes C., PhD

    Universidad Católica del Maule

    STUDY DIRECTOR
  • Camila Riquelme B.

    Universidad Andrés Bello

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator: Statistical data analyst.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial (RCT).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

March 15, 2023

First Posted

May 3, 2023

Study Start

April 4, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations