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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Conventional physical rehabilitation (CPR) / Active video games (AVG)
Conventional physical rehabilitation (CPR)
Sponsored by
Cristian Alvarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarhrosis, elderly, exercise training, video games, public health

Eligibility Criteria

60 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Salud Familiar (CESFAM) Lorenzo ArenasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Conventional physical rehabilitation (CPR) / Active video games (AVG)

Conventional physical rehabilitation (CPR)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Lower body strength.
30-s chair stand. Number of full stands in 30 s with arms folded across chest
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)
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)
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
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 - )
Change in Hand grip strength
Number of kg measured with a Jamar dynamometer.
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.
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.
Change in Pain intensity.
Visual Analog Scale (VAS). 100 mm straight line with two labels ("no pain" and "worst possible pain") at each end.
Change in Pressure pain threshold
Wagner® FPX-25 algometer. It is expressed in kilogram/cm2.
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]).
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).
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.
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.

Full Information

First Posted
March 15, 2023
Last Updated
April 19, 2023
Sponsor
Cristian Alvarez
Collaborators
National Fund for Research and Development in Health, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT05839262
Brief Title
Active Video Games for Older Adults With Knee and/or Hip Osteoarthritis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristian Alvarez
Collaborators
National Fund for Research and Development in Health, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, we propose 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip
Keywords
osteoarhrosis, elderly, exercise training, video games, public health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial (RCT).
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator: Statistical data analyst.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Conventional physical rehabilitation (CPR) / Active video games (AVG)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional physical rehabilitation (CPR)
Intervention Type
Other
Intervention Name(s)
Conventional physical rehabilitation (CPR) / Active video games (AVG)
Intervention Description
In each session a routine of conventional exercises and active video games is performed. The duration is 10 weeks / 3 sessions per week (30 sessions). CPR: Conventional exercises (aerobic, muscle strengthening, postural balance and flexibility). AVG: Set of interactive video games available for the Nintendo Switch console.
Intervention Type
Other
Intervention Name(s)
Conventional physical rehabilitation (CPR)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Functional mobility.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Lower body strength.
Description
30-s chair stand. Number of full stands in 30 s with arms folded across chest
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.
Title
Change in Upper body strength.
Description
30-s arm curl. Number of bicep curls in 30 s holding hand weight (women 5 lb; men 8 lb)
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.
Title
Change in Aerobic endurance.
Description
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)
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.
Title
Change in Lower body flexibility
Description
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
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.
Title
Change in Upper body flexibility.
Description
Back scratch. With one hand reaching over shoulder and one up middle of back, number of inches between extended middle fingers (+ or - )
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.
Title
Change in Hand grip strength
Description
Number of kg measured with a Jamar dynamometer.
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.
Title
Change in Functional disability.
Description
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.
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.
Title
Change in Cognitive performance.
Description
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.
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.
Title
Change in Pain intensity.
Description
Visual Analog Scale (VAS). 100 mm straight line with two labels ("no pain" and "worst possible pain") at each end.
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.
Title
Change in Pressure pain threshold
Description
Wagner® FPX-25 algometer. It is expressed in kilogram/cm2.
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.
Title
Change in Health-related quality of life
Description
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]).
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.
Title
Adherence to treatment
Description
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).
Time Frame
One-time point. At week 10 (after 30 sessions from baseline).
Title
Change in User satisfaction
Description
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.
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).
Title
Change in Therapeutic alliance
Description
Subscale of the Pain Rehabilitation Expectations Scale (PRES). The score ranges from 1 to 44; a higher score is a higher 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Guede Rojas, PhD
Phone
+56968351445
Email
francisco.guede@unab.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Cristian Alvarez, PhD
Email
cristian.alvarez@unab.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristhian Mendoza S., PhD
Organizational Affiliation
Universidad San Sebastian
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claudio Carvajal P., PhD
Organizational Affiliation
Universidad San Sebastian
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorge Fuentes C., PhD
Organizational Affiliation
Universidad Católica del Maule
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Camila Riquelme B.
Organizational Affiliation
Universidad Andrés Bello
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Salud Familiar (CESFAM) Lorenzo Arenas
City
Concepción
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Guede Rojas, PhD
Phone
+56968351445
Email
francisco.guede@unab.cl

12. IPD Sharing Statement

Plan to Share IPD
No
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Active Video Games for Older Adults With Knee and/or Hip Osteoarthritis.

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