Osteoarthritis, KneeNCT05839262
Active Video Games for Older Adults With Knee and/or Hip Osteoarthritis.
A study testing Conventional physical rehabilitation plus Active video games (CPR+AVG) and Conventional physical rehabilitation alone (CPR) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Cristian Alvarez at 1 site in Chile.
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… Read more about this study
- Who is it for?
- Ages 60 to 84 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Conventional physical rehabilitation plus Active video games (CPR+AVG) and Conventional physical rehabilitation alone (CPR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 4 Apr 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed 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:
- To characterize the study sample from sociodemographic, anthropometric, clinical, and psychosocial perspectives.
- 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.
- To evaluate the clinical significance of the interventions and the clinical relevance of the interventions as perceived by the participants.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Conventional physical rehabilitation plus Active video games (CPR+AVG), Conventional physical rehabilitation alone (CPR)
- Keywords
- osteoarhrosis, elderly, exercise training, video games, public health
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical rehabilitation plus Active video games (CPR+AVG)Other
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)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Conventional physical rehabilitation plus Active video games (CPR+AVG) Receives: Other: Conventional physical rehabilitation plus Active video games (CPR+AVG) |
| Control group | Active comparator | Conventional physical rehabilitation alone (CPR) Receives: Other: Conventional physical rehabilitation alone (CPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
30-s chair stand. Number of full stands in 30 s with arms folded across chest
Measured: 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.
30-s arm curl. Number of bicep curls in 30 s holding hand weight (women 5 lb; men 8 lb)
Measured: 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.
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)
Measured: 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
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
Measured: 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.
Back scratch. With one hand reaching over shoulder and one up middle of back, number of inches between extended middle fingers (+ or - )
Measured: 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 Hand grip strength
Number of kg measured with a Jamar dynamometer.
Measured: 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 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.
Measured: 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 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.
Measured: Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
Change in Pain intensity.
Visual Analog Scale (VAS). 100 mm straight line with two labels ("no pain" and "worst possible pain") at each end.
Measured: 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 Pressure pain threshold
Wagner® FPX-25 algometer. It is expressed in kilogram/cm2.
Measured: 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 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]).
Measured: Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
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).
Measured: One-time point. At week 10 (after 30 sessions from baseline).
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.
Measured: 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).
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 Apr 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial (RCT).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristian Alvarez
- Sponsor type
- University, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Responsible party
- Sponsor-investigator, Cristian Alvarez, Universidad Nacional Andres Bello
- Investigators
- Cristhian Mendoza S., PhD, Study chair, Universidad San SebastianClaudio Carvajal P., PhD, Study director, Universidad San SebastianJorge Fuentes C., PhD, Study director, Universidad Católica del MauleCamila Riquelme B., Study director, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839262
- Sponsor's protocol ID
- UNAB-FCR-KINE2023B
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31964664Rosen 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.
PubMed 31735982Ho 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.
PubMed 32202045Mat 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.
PubMed 28218341Manlapaz 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.
PubMed 30609282Hurley 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.
PubMed 29664187Klaps 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.
PubMed 35243924Hawley-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.
PubMed 27338884Room 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.
PubMed 29247111Franco 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.
PubMed 25586911Cigarroa 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.
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.
PubMed 31283482Mirelman 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.
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.
PubMed 26193189Zheng 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.
PubMed 31520334
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05839262
- Acronym / sponsor ID
- UNAB-FCR-KINE2023B
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- osteoarhrosis, elderly, exercise training, video games, public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cristian AlvarezUniversity, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To characterize the study sample from sociodemographic, anthropometric, clinical, and psychosocial perspectives.
- 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.
- To evaluate the clinical significance of the interventions and the clinical relevance of the interventions as perceived by the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Conventional physical rehabilitation plus Active video games (CPR+AVG)Conventional physical rehabilitation plus Active video games (CPR+AVG) |
| Control group | Active comparator | Other: Conventional physical rehabilitation alone (CPR)Conventional physical rehabilitation alone (CPR) |
Who may qualify
- Ages
- 60 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental group |
| 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). | Other | Control group |
Primary outcome
Change in Functional mobility.
Time frame: 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.
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.
14 secondary outcomes
Change in Lower body strength.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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 Hand grip strength
Time frame: 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 Functional disability.
Time frame: 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 Cognitive performance.
Time frame: Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
Change in Pain intensity.
Time frame: 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 Pressure pain threshold
Time frame: 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 Health-related quality of life
Time frame: Three-time points. Baseline (pre-intervention); and week 10 (after 30 sessions from baseline). In addition, four weeks after the completion of the intervention.
Adherence to treatment
Time frame: One-time point. At week 10 (after 30 sessions from baseline).
Change in User satisfaction
Time frame: 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).
Change in Therapeutic alliance
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 31964664Spitaels 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.
- Background: PubMed 31735982Rosen 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.
- Background: PubMed 32202045Ho 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.
- Background: PubMed 28218341Mat 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.
- Background: PubMed 30609282Manlapaz 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.
- Background: PubMed 29664187Hurley 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.
- Background: PubMed 35243924Klaps 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.
- Background: PubMed 27338884Hawley-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.
- Background: PubMed 29247111Room 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.
- Background: PubMed 25586911Franco 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.
- BackgroundCigarroa 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: PubMed 31283482Torner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristhian Mendoza S., PhD study chair
Universidad San Sebastian
Claudio Carvajal P., PhD study director
Universidad San Sebastian
Jorge Fuentes C., PhD study director
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical rehabilitation plus Active video games (CPR+AVG) and Conventional physical rehabilitation alone (CPR) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Cristian Alvarez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional mobility. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839262, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.