Active Video Games for Older Adults With Knee and/or Hip Osteoarthritis.

Osteoarthritis, Knee Clinical Trial

Official title:

Physical Exercise Guided by Active Video Games for Optimizing Clinical and Psychosocial Outcomes in Older Adults With Knee and/or Hip Osteoarthritis Under a Community-based Rehabilitation Model.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839262
• Other study ID #: UNAB-FCR-KINE2023B
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: November 28, 2024

Study information

• Verified date: March 2024
• Source: Universidad Nacional Andres Bello
• Contact: Francisco Guede Rojas, PhD
• Phone: +56968351445
• Email: francisco.guede[@]unab.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteoarthritis (OA) is highly prevalent, and its incidence increases with aging populations. OA is characterized by articular cartilage degeneration, stiffness, inflammation, and musculoskeletal pain. In addition, the associated deterioration of health-related quality of life may influence therapeutic adherence and progression to future joint replacement. It appears that symptoms rather than structural impairment determine the risk of falling in older people with OA, so pain, loss of strength, and postural balance are underlying mechanisms for both falls and the clinical picture of OA itself. Moreover, the psychosocial sequelae are often underestimated because OA and pain are usually considered benign and unavoidable consequences of aging.

Physical exercise in people with knee and hip OA improves clinical aspects and psychosocial aspects such as self-efficacy, social function, and reduction of depression and isolation, among others. Adherence to exercise is fundamental and is closely related to user satisfaction. There are several barriers to physical exercise by older adults, such as lack of social support, transportation problems, and prioritization of basic needs; however, a determining factor is lack of motivation. In this regard, a study indicates that in Latin America, lack of motivation is among the main reasons for abandoning physical exercise.

The technological development of the last decades has allowed the incorporation of virtual reality into the healthcare field, favoring user motivation. Virtual reality is an experience based on the interactive digital simulation of environments and objects. These systems are categorized as non-immersive, semi-immersive, and immersive. Non-immersive systems use monitors or television screens, semi-immersive systems use panoramic screens to enhance the immersive experience, and immersive systems use head-mounted displays or multi-projected environments that generate a strong sense of immersion. It has been posited that the cost and expertise required to operate immersive systems may hinder their widespread use in clinical settings. In addition, the immersive sensation could produce symptoms such as visual fatigue and dizziness (cybersickness). On the other hand, non-immersive systems using commercially available home consoles are now considered an attractive and more accessible alternative to more sophisticated immersive systems.

Unlike traditional video games that use a standard command or joystick, active video games (AVGs) (also called exergames) use motion monitoring systems such as accelerometers, gyroscopes, haptic technology, and video capture. AVGs have been defined as a "combination of video game technologies and exercise routines to motivate physical activity among individuals or groups," recognizing that exercise in older people requires a greater understanding of the complexity of interaction with computer systems.

Conventional physical rehabilitation (CPR) consists of traditional physical exercises that improve functional capacity. Over the past few years, it has been suggested that incorporating AVGs into CPR can optimize clinical and psychosocial outcomes in the elderly. AVGs have been reported to promote improvements in functional mobility, coordination, muscle strength, and cognitive function in older people. In addition, AVGs improve walking ability and postural balance, as well as social well-being (perception of loneliness, social connectedness, and positive attitudes). However, this research has focused on healthy elderly and patients with neurocognitive pathologies. On the other hand, little information is available on older people with musculoskeletal conditions such as OA. In this regard, a systematic review conducted in patients with knee and/or hip OA indicates that the evidence is insufficient and inconclusive regarding the effectiveness of AVGs. Moreover, one study concludes that AVGs are a feasible and acceptable intervention for patients with knee OA. Interestingly, both studies raise the benefits and potential of AVGs in this population, urging further clinical trials.

Research question: In older adults with knee and/or hip OA. Is AVG-guided physical exercise adjunct to CPR more effective than CPR alone in improving clinical and psychosocial outcomes?

Working hypothesis: In older adults with knee and/or hip OA, AVG-guided physical exercise adjunct to CPR is more effective than CPR alone in improving clinical and psychosocial outcomes.

General objective: To determine the effects of an AVG-guided physical exercise program adjunct to CPR on clinical and psychosocial outcomes in older adults with knee and/or hip OA attended at a community-based family health center.

Specific objectives:

1. To characterize the study sample from sociodemographic, anthropometric, clinical, and psychosocial perspectives.

2. To compare the results of the primary outcome (functional mobility) and secondary outcomes between the study groups (experimental and control) in the different instances of outcome measurement.

3. To evaluate the clinical significance of the interventions and the clinical relevance of the interventions as perceived by the participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 28, 2024
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 84 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Chile	Centro de Salud Familiar (CESFAM) Lorenzo Arenas	Concepción

Sponsors (2)

Lead Sponsor	Collaborator
Cristian Alvarez	National Fund for Research and Development in Health, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (35)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Lower body strength.	30-s chair stand. Number of full stands in 30 s with arms folded across chest	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	Change in Upper body strength.	30-s arm curl. Number of bicep curls in 30 s holding hand weight (women 5 lb; men 8 lb)	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	Change in Aerobic endurance.	2-min step test. Number of full steps completed in 2 min,raising each knee to point midway between patella and iliac crest (score is number of times right knee reaches target)	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	Change in Lower body flexibility	Chair sit-and-reach. From sitting position at front of chair, with leg extended and hands reaching toward toes, number of inches (+or - ) from extended fingers to tip of toe	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	Change in Upper body flexibility.	Back scratch. With one hand reaching over shoulder and one up middle of back, number of inches between extended middle fingers (+ or - )	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	Change in Hand grip strength	Number of kg measured with a Jamar dynamometer.	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	Change in Functional disability.	Western Ontario McMaster Osteoarthritis Index (WOMAC) questionnaire. Score obtained on the scale of items grouped into 3 dimensions: pain, stiffness and difficulty in performing tasks. Scores range from 0 to 96, where 0 represents the best health status and 96 the worst possible status.	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	Change in Cognitive performance.	Montreal Cognitive Assessment (MoCA) test. Score obtained in the development of the tests. It considers executive functions, attention, abstraction, memory, language, viso-constructive abilities, calculation and orientation. MoCA scores range from 0 to 30; higher scores indicate a better cognitive performance.	Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
Secondary	Change in Pain intensity.	Visual Analog Scale (VAS). 100 mm straight line with two labels ("no pain" and "worst possible pain") at each end.	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	Change in Pressure pain threshold	Wagner® FPX-25 algometer. It is expressed in kilogram/cm2.	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	Change in Health-related quality of life	SF-12v2 Chile-Spanish Questionnaire. Score from 0-100 points. Assessment of 8 dimensions (physical functioning [PF], role-physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]), and two summary scores (physical component summary [PCS] and mental component summary [MCS]).	Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
Secondary	Adherence to treatment	Number of effective assistances at the end of treatment. A participant with an attendance =2/3 of the total (30 sessions) is considered "adherent" (=20 sessions).	One-time point. At week 10 (after 30 sessions from baseline).
Secondary	Change in User satisfaction	The average score of 3 questions (overall level of satisfaction, expectation fulfillment, and recommendations to others) using a scale of 1 to 7 points, where 1 is the worst evaluation, and 7 is the best evaluation.	Three-time points. At week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline).
Secondary	Change in Therapeutic alliance	Subscale of the Pain Rehabilitation Expectations Scale (PRES). The score ranges from 1 to 44; a higher score is a higher therapeutic alliance.	Three-time points. At week 4 (after ten sessions from baseline); at week 7 (after 20 sessions from baseline); and week 10 (after 30 sessions from baseline).