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

NCT04336670 | Completed

• 1 other identifier: HEALTHYFIT-UVIGO 2020/078
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging; Fall; Quality of Life

Keywords

Aged; Virtual Reality Exposure Therapy; Balance; Biomedical Technology; Exercise Therapy; Physical Therapy Modalities; Quality of Life

Outcome Measures

Primary Outcomes (20)

• Simulator Sickness Questionnaire

  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.

  4 weeks

• Simulator Sickness Questionnaire

  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.

  10 weeks

• System Usability Scale

  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 weeks

• System Usability Scale

  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.

  10 weeks

• Game Experience Questionnaire (post game module)

  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).

  4 weeks

• Game Experience Questionnaire (post game module)

  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).

  10 weeks

• Tinetti Test

  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.

  pre intervention

• Tinetti Test

  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 weeks

• Tinetti Test

  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.

  14 weeks

• Five times sit to stand test

  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

  pre intervention

• Five times sit to stand test

  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

  10 weeks

• Five times sit to stand test

  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

  14 weeks

• Time Up and Go Test

  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.

  pre intervention

• Time Up and Go Test

  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.

  10 weeks

• Time Up and Go Test

  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.

  12 weeks

• SF-12 Scale

  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).

  pre intervention

• SF-12 Scale

  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).

  10 weeks

• Strengh

  handgrip strength

  pre intervention

• Strengh

  handgrip strength

  10 weeks

• Strengh

  handgrip strength

  14 weeks

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

Immersive Virtual Reality exercise program + Usual center therapies

Device: Immersive Virtual Reality exercise program

Usual activities group

ACTIVE COMPARATOR

Usual center therapies

Other: Usual care

Interventions

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.

Virtual Reality group

Usual care OTHER

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

Usual activities group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Saraiva Senior Center members
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pablo Campo-Prieto: lead
• Saraiva Senior Center: collaborator

Study Sites (1)

Pablo Campo-Prieto

Pontevedra, Galicia, 36005, Spain

Location

Study Officials

• Pablo Campo-Prieto, PT M. Sc.

  HealthyFit Research Group - University of Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: October 11, 2021
• Primary Completion: October 11, 2021
• Study Completion: December 29, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

ES (1)