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Completed

NCT Number: NCT04336670

Design and Implementation of a Physical Exercise Program With Virtual Reality to Improve Functional Capacities in Older People.

TITLE: Desing and implementation of a Immersive Virtual Reality exercise program to improve balance in older people

INTRO: Older people grow around the world at a faster rate than any other age group, resulting in an accelerated aging of the population and an increase in life expectancy. In response to this new reality, active aging programs and strategies are especially relevant and it based in physical activity practice, whose main objective is to maintain or improve the functionality of the person, even though the loss of balance in the elderly represents a significant difficulty in their lives, since this aspect reduces their postural control, increasing the risk of falls and injuries. Our project REVIEM (Inmersive Virtual Reality Exergaming in Olders) is a new strategy to improve the balance in older people, using a exercise program with Virtual Reality glasses for this purpose.

HYPOTHESIS: The practice of REVIEM protocol based on physical function training in older adults collaborates in the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy.

GENERAL GOALS:

1.1 Design and implement a REVIEM exercise program / protocol to improve balance in older people 1.2 Analyze the effects of this REVIEM program / protocol, in the short and medium term in institutionalized individuals.

1.3 Identify if there is a relationship between the variables that induce fragility and functional dependence and the REVIEM protocol

SPECIFIC GOALS:

2.1 Determine the REVIEM protocol to improve differential effects for 6 minutes a day (3 days a week for 10 weeks)

2.1.1 The improvement of the functional independence of individuals by improving balance, reducing the risk of falls and proper development in activities of daily living.

2.1.2 The improvement of gait. 2.1.3 The improvement of quality of life. 2.1.4 The improvement of handgrip.

2.2 Determine the parameters related to immerse virtual reality exposure. 2.2.1 Safety of the virtual reality exposure 2.2.2 Usability of the virtual reality exposure 2.2.3 Personal experiences and satisfaction of the virtual reality exposure

METHODS:

Design: Randomized controlled trial. The institutionalized elderly from the geriatric center Saraiva Senior Center in Pontevedra, Spain, will be invited to take part in the study. After they meet the selection criteria, they will be assigned to on experimental group and one control group. Information regarding sociodemographic characteristics and a clinical anamnesis of the participants will be collected.

Intervention: Two groups (experimental and control). Experimental group will perform the REVIEM protocol sessions (6 min) focused on the upper and lower limbs. (3 sessions per week for 10 weeks). All sessions will begin with a warm-up focused on the stimulation of coordination and joint mobilization, so that the body is predisposed both centrally and peripherally for the performance of the session and will end with a stretching routine accompanied by breathing cycles calm and controlled. The session will be supervised by the physiotherapist, occupational therapist or expert in physical exercise of the center.

Control group will participate in the usual activities proposed by the center management.

Assessments: 4 evaluations will be carried: initial, intermediate (at 1 month), final (at 10 weeks) and follow-up (1 month after to end the program).

The contents of the assessmentens will be:

1. Characteristics of patients: "ad hoc" record sheet that will include data on age, sex, associated pathologies and pharmacological treatment. 2. REVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)

2. Balance, gait and fall risk (Tinetti Test) 3. Functional mobility and lower limbs strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test) 5. Quality of life (SF-12 Scale) 6. Handgrip (dynamometer)

Hypothesis : our findings aim to support the use of new health technologies in the field of rehabilitation and healthcare for the elderly, achieving a feasible and safety Immersive Virtual Reality exergaming program.

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Key information

Conditions

Aging Fall Quality of Life

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pablo Campo-Prieto

Pontevedra, Galicia, 36005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Saraiva Senior Center members
  • Signed informed consent

Exclusion criteria

  • Comorbidity that discourages the exercise of physical exercise and that allows to carry out all the programmed evaluations.
  • Mobility problems that prevent compliance with the protocol.
  • Serious visual and / or auditory disturbances that impede the development of the session, as well as those with a history of vertigo, seizures or epileptic seizures to prevent exacerbations of these symptoms as potential adverse effects of Immersive Virtual Reality.
  • Severe cognitive impairment.

Treatment and study plan

Immersive Virtual Reality exercise program

Device

Sessions with an exercise program focused in upper and low limbs movements in a virtual enviroment, all performed in standing position.

Usual Care

Other

Usual center therapies (Physical therapy, occupational therapy..)

Primary outcomes

  1. Simulator Sickness Questionnaire

    Time frame: 4 weeks

    SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.

  2. Simulator Sickness Questionnaire

    Time frame: 10 weeks

    SSQ is used for measuring users' level of sickness symptoms and is highly appreciated in VR research. Each item is rated with the scale from none, slight, moderate to severe. Through some calculations, four representative scores can be found. Nausea-related subscore (N), Oculomotorrelated subscore (O), Disorientation-related subscore (D) are the scores for the symptoms for the specific aspects. Total Score (TS) is the score representing the overall severity of cybersickness experienced by the users of virtual reality systems.

  3. System Usability Scale

    Time frame: 4 weeks

    SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.

  4. System Usability Scale

    Time frame: 10 weeks

    SUS provides a quick and reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. It allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.

  5. Game Experience Questionnaire (post game module)

    Time frame: 4 weeks

    GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).

  6. Game Experience Questionnaire (post game module)

    Time frame: 10 weeks

    GEQ can be applied after playing the game, several times over a longer period - also to see the changes in the experience. It is applicable for lab and field evaluation studies.Post game module - conserns experiences once a player has stopped gaming.Captures the game experience based on a number of items (such as positive affect, competence, immersion, flow, challenge).

  7. Tinetti Test

    Time frame: pre intervention

    The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.

  8. Tinetti Test

    Time frame: 10 weeks

    The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.

  9. Tinetti Test

    Time frame: 14 weeks

    The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls.

  10. Five times sit to stand test

    Time frame: pre intervention

    FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements

  11. Five times sit to stand test

    Time frame: 10 weeks

    FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements

  12. Five times sit to stand test

    Time frame: 14 weeks

    FTSTS is used to objectively determine measures to provide a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements

  13. Time Up and Go Test

    Time frame: pre intervention

    Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.

  14. Time Up and Go Test

    Time frame: 10 weeks

    Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.

  15. Time Up and Go Test

    Time frame: 12 weeks

    Standardized test to assess the basic functional mobility of elderly persons and requires both static and dynamic balance. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.

  16. SF-12 Scale

    Time frame: pre intervention

    It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).

  17. SF-12 Scale

    Time frame: 10 weeks

    It is one of the most used questionnaires to evaluate the multidimensional health related quality of life, worldwide. The 12 items are a subset of those in the SF-36 and measures 8 concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being).

  18. Strengh

    Time frame: pre intervention

    handgrip strength

  19. Strengh

    Time frame: 10 weeks

    handgrip strength

  20. Strengh

    Time frame: 14 weeks

    handgrip strength

Sponsors and collaborators

Lead sponsor

Pablo Campo-Prieto

Other

Collaborators

  • Saraiva Senior Center

Registry information

Official study title

Design and Implementation of a Immersive Virtual Reality Physical Exercise Program to Improve Functional Capacities in Older People.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2020
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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