Clinical trial NCT06864325: VR Gaming and Its Impact on Functional Status and Quality of Life in Seniors
Official title: Assessment of Changes in Functional Status and Quality of Life in Seniors Engaging in Virtual Reality-based Physical Activity: Influence of Diet, Oral Microflora Composition, Blood Morphology, and Anthropometric Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: virtual reality
functional statut
quality of life
older adults
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This project examined the impact of virtual reality (VR)-based physical activity on the functional status and quality of life (QoL) of older residents in a nursing home. It is know that VR-related therapy and activation programs help in a positive attitude toward health and emotions, reduce susceptibility to depression and social isolation, and enhance engagement in physical activities. As an atrractive and motivating tools, VR have the potential to promote greater physical activity and overall improvement, including functional status and QoL in older adults. Such findings indicate that incorporating VR into exercise programs for the older adults may enhancements in functional status and QoL compared to traditional, non-VR-based therapy.

The primary goal of this study was to assess changes in functional status and QoL in older participants in VR-based physical activity. The project involves a comprehensive evaluation, including assessments of physical and psychomotor fitness, body composition, key blood morphology parameters, lipid profile, blood glucose levels, oral microbiome composition, and overall well-being. Additionally, psychological factors such as anxiety levels is examined, assuming that these parameters may improve through VR-enhanced physical activity.

The investigators hypothesize that VR-based therapy will leads to significant improvements in psychomotor and functional fitness, exercise tolerance, and overall well-being, thereby enhancing the QoL in older adults. The findings of this research may contribute to the development of innovative programs aimed at supporting elderly individuals in maintaining and improving their functional status-whether during recovery, rehabilitation, or in sustaining optimal physical and mental health.

Detailed description: The project involved older adults residing in a nursing home, who are randomly assigned to one of two study groups: the intervention group with participants undergo virtual reality (VR)-based training, and the control group with participants engage in standard activities provided by the nursing home. Our study design assumes that the participants will undergo 2 rounds of testing conducted before therapy to evaluate the subjects' initial condition (T0 testing), and after therapy to assess the effects of the intervention (T1 testing). These assessments will be separated by a four-week period during which the intervention group completes 12 VR-based sessions.

Scope of assessments at T0 and T1 includes:

I. survey studies - introductory custom questionnaire, questionnaires assessing mental health, quality of life, functional fitness in daily activities, complex activities of daily living, and functional independence; II. psychomotor assessments - tests of eye-hand coordination and attention concentration; III. physical fitness assessment - grip strength measurements, general physical fitness evaluation, analysis of body composition; IV. lifestyle and biological assessments - oral microbiota assessment, laboratory tests including peripheral blood morphology, lipid profile, glucose level and C-reactive protein concentration, and analysis of nutritional habits.

Moreover, participants in the intervention group during VR gaming possess evaluation of parameters indicating intervention effectiveness, and measurement of heart rate, energy expenditure, and oxygen saturation levels.

Eligibility criteria: Inclusion criteria:

* age 60 or older
* signing an informed consent to participate in the study
* willingness to participate in the therapy program.

Exclusion criteria:

* lack of consent
* contraindications to VR headset using (current temporary conditions: fatigue or exhaustion, drowsiness, nausea, anxiety or stress, cold, flu)
* chronic conditions (cancer in an intensive treatment phase, inability to exercise, visual or auditory disorders preventing VR goggles use, cognitive disorders that hindered understanding exercise instructions or cooperation with the researcher).

Eligibility was determined by a physician who assessed each participant's health condition, and screened for contraindications to a head-mounted display VR use.

Primary outcomes:
measure: Own survey research
timeFrame: 76 days
measure: Survey research - the levels of anxiety and depression
timeFrame: 76 days
measure: Survey research - quality of life
timeFrame: 76 days
measure: Survey research - functional ability
timeFrame: 76 days
measure: Survey research - activities of daily living
timeFrame: 76 days
measure: Survey research - functional independence
timeFrame: 76 days
measure: Psychomotor assessments - tests of eye-hand coordination (EHC) and attention concentration (AC),
timeFrame: 76 days
measure: Physical fitness assessment - grip strength measurements
timeFrame: 76 days
measure: Physical fitness assessment - upper body strength
timeFrame: 76 days
measure: Physical fitness assessment - shoulder flexibility
timeFrame: 76 days
measure: Physical fitness assessment - lower body strength
timeFrame: 76 days
measure: Physical fitness assessment - lower body flexibility
timeFrame: 76 days
measure: Physical fitness assessment - speed, agility, and balance
timeFrame: 76 days
measure: Physical fitness assessment - aerobic endurance
timeFrame: 76 days
measure: Lifestyle and biological assessments - oral microbiota
timeFrame: 76 days
measure: Lifestyle and biological assessments - laboratory tests
timeFrame: 76 days
measure: Lifestyle and biological assessments - adherence to healthy eating principles
timeFrame: 76 days
measure: Lifestyle and biological assessments - compliance with dietary recommendations
timeFrame: 76 days
measure: Lifestyle and biological assessments - quantitative diet analysis
timeFrame: 76 days
measure: Lifestyle and biological assessments - qualitative diet assessment
timeFrame: 76 days
measure: Anthropometric data - height
timeFrame: 76 days
measure: Anthropometric data - weight
timeFrame: 76 days
measure: Anthropometric data - body mass index
timeFrame: 76 days
measure: Physical fitness assessment - body composition analysis
timeFrame: 76 days
measure: Anthropometric data - body circumferences
timeFrame: 76 days
measure: Anthropometric data - skinfold thickness
timeFrame: 76 days
Secondary outcomes:
measure: Heart ratio
timeFrame: 76 days
measure: Energy expenditure
timeFrame: 76 days
measure: Saturation
timeFrame: 76 days
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Faculty of Physical Education and Physiotherapy, Opole University of Technology
city: Opole
country: Poland
facility: Faculty of Production Engineering and Logistics, Opole University of Technology
Study officials:
References: