Clinical trial NCT04336670: Design and Implementation of a Physical Exercise Program With Virtual Reality to Improve Functional Capacities in Older People.
Official title: Design and Implementation of a Immersive Virtual Reality Physical Exercise Program to Improve Functional Capacities in Older People.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Fall
Quality of Life
Keywords: Aged
Virtual Reality Exposure Therapy
Balance
Biomedical Technology
Exercise Therapy
Physical Therapy Modalities
Quality of Life
Lead sponsor: University of Vigo
Sponsor class: OTHER
Collaborators: name: Saraiva Senior Center
First posted: 2020-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Simulator Sickness Questionnaire
timeFrame: 4 weeks
measure: Simulator Sickness Questionnaire
timeFrame: 10 weeks
measure: System Usability Scale
timeFrame: 4 weeks
measure: System Usability Scale
timeFrame: 10 weeks
measure: Game Experience Questionnaire (post game module)
timeFrame: 4 weeks
measure: Game Experience Questionnaire (post game module)
timeFrame: 10 weeks
measure: Tinetti Test
timeFrame: pre intervention
measure: Tinetti Test
timeFrame: 10 weeks
measure: Tinetti Test
timeFrame: 14 weeks
measure: Five times sit to stand test
timeFrame: pre intervention
measure: Five times sit to stand test
timeFrame: 10 weeks
measure: Five times sit to stand test
timeFrame: 14 weeks
measure: Time Up and Go Test
timeFrame: pre intervention
measure: Time Up and Go Test
timeFrame: 10 weeks
measure: Time Up and Go Test
timeFrame: 12 weeks
measure: SF-12 Scale
timeFrame: pre intervention
measure: SF-12 Scale
timeFrame: 10 weeks
measure: Strengh
timeFrame: pre intervention
measure: Strengh
timeFrame: 10 weeks
measure: Strengh
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Pablo Campo-Prieto
state: Galicia
Study officials:
affiliation: HealthyFit Research Group - University of Vigo
name: Pablo Campo-Prieto, PT M. Sc.
role: PRINCIPAL_INVESTIGATOR
References: