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

NCT04336670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-11-10

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

Usual care

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

Sponsors & Collaborators

  • Saraiva Senior Center

    collaborator UNKNOWN
  • Pablo Campo-Prieto

    lead OTHER

Principal Investigators

  • Pablo Campo-Prieto, PT M. Sc. · HealthyFit Research Group - University of Vigo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2021-10-11
Completion
2021-12-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336670 on ClinicalTrials.gov