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

NCT ID: NCT04336670

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2021-12-29

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.

Conditions

Aging; Fall; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Virtual Reality group

Immersive Virtual Reality exercise program + Usual center therapies

Group Type: EXPERIMENTAL

Immersive Virtual Reality exercise program

Intervention Type: DEVICE

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

Usual activities group

Usual center therapies

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

Immersive Virtual Reality exercise program

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

Intervention Type: DEVICE

Usual care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saraiva Senior Center

UNKNOWN

Sponsor Role: collaborator

Pablo Campo-Prieto

OTHER

Sponsor Role: lead

Responsible Party

Pablo Campo-Prieto

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pablo Campo-Prieto, PT M. Sc.

Role: PRINCIPAL_INVESTIGATOR

HealthyFit Research Group - University of Vigo

Locations

Pablo Campo-Prieto

Pontevedra, Galicia, Spain

Countries

Spain

Other Identifiers

HEALTHYFIT-UVIGO 2020/078

Identifier Type: -

Identifier Source: org_study_id