Older AdultsNCT06864325
VR Gaming and Its Impact on Functional Status and Quality of Life in Seniors
A study testing VR-training in people with Older Adults, run by The Opole University of Technology at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- VR-training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesPoland
- Study dates
- 17 Jul 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60 or older
- signing an informed consent to participate in the study
- willingness to participate in the therapy program.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
Faculty of Production Engineering and Logistics, Opole University of Technology
Opole, 45-758
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Older Adults
- Being tested
- VR-training
- Keywords
- virtual reality, functional statut, quality of life, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-trainingOther
Also called VR-gaming
The VR gaming experience is based on the commercial rhythm game Beat Saber, featuring songs by Queen with varying rhythms and tempos. Players receive visual stimuli in the form of colored square blocks and must slice them in time with the music using the corresponding right or left hand. The blocks must be cut with a lightsaber of the same color. To ensure the safety of older adults, heart rate and energy expenditure were monitored throughout each session, while oxygen saturation was assessed before and after the exercises. Participants playe the game in comfortable conditions: the game loaded directly into the headset and VR glasses synchronized with portable screens to allow monitoring and assistance if needed. Before each session, the headset was adjusted to fit the participant's head dimensions, and corrective glasses were provided if required. The VR setup included a Meta Quest 2 headset with goggles and user-friendly controllers equipped with sensors (Meta Platforms, U.S.).
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | The VR group underwent a four-week training program, with sessions held three times per week, each lasting 20 minutes. Initially, an introductory session was organized to familiarize the participants with virtual reality. Following this, the structured training program consisted of 12 sessions over the four-week period. All sessions were conducted in a seated position to ensure comfort and safety. Receives: Other: VR-training |
| Control group | No intervention | The control group was a passive group that do not receive any specific intervention, engaging only in the standard daily exercises provided at the nursing home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Own survey research
The study included a custom questionnaire assessing demographic data, physical activity, quality of life, diet, oral prophylaxis, existing diseases, and medications taken, administered before intervention (at the T0). A follow-up questionnaire evaluated participants' impressions of the VR intervention is conducted after intervention (T1).
Measured: 76 days
Survey research - the levels of anxiety and depression
At both T0 and T1 time points mental health was assessed using the Hospital Anxiety and Depression Scale (HADS).
Measured: 76 days
Survey research - quality of life
At both T0 and T1 time points quality of life was measured with the World Health Organization's short Quality of Life Scale (WHOQOL-BRIEF)
Measured: 76 days
Survey research - functional ability
At both T0 and T1 time points a functional ability in daily life was assessed through Activities of Daily Living (ADL) according to the Katz Index.
Measured: 76 days
Survey research - activities of daily living
At both T0 and T1 time points Instrumental Activities of Daily Living (IADL) using the Lawton Scale.
Measured: 76 days
Survey research - functional independence
At both T0 and T1 time points a functional independence was measured with the Functional Independence Measure (FIM).
Measured: 76 days
Psychomotor assessments - tests of eye-hand coordination (EHC) and attention concentration (AC),
The cross visual motor test using the Piórkowski apparatus (PIOR/ATB 2.0) was used to assess EHC and AC. During the test, the participant was seated comfortably in front of the apparatus with their hands positioned over the buttons. The following test pattern was used: a duration of 90 seconds, with 1-second light intervals and stimulus frequency of 90 stimuli per 90 seconds. On the device's panel, lights were illuminated in random sequences, and the participant had to respond immediately by pressing the corresponding button as quickly and accurately as possible. The device recorded the subject's movements, reaction times and errors for each light stimulus. The test was conducted over three consecutive trials and an average score was calculated for each metric.
Measured: 76 days
Physical fitness assessment - grip strength measurements
The test was conducted in a sitting position with the forearm resting on a table and the elbow bent at a 90-degree angle, The participant clenched their hand for 3 seconds; the test was repeated 3 times. The average result was then compared to normative values for muscle strength
Measured: 76 days
Physical fitness assessment - upper body strength
The assessment was conducted using a Arm Curl Test - a part of Fullerton Functional Fitness Test. The participant sits on a chair, holding a weight (approximately 2.27 kg for women and 3.63 kg for men) in the dominant hand. The arm was positioned downward alongside the chair, perpendicular to the floor, with the palm facing inward. Upon the "start" signal, the participant bends the elbow, lifting the weight toward the shoulder, and then returns to the starting position. The total number of correctly performed repetitions within 30 seconds was recorded.
Measured: 76 days
Physical fitness assessment - shoulder flexibility
The assessment was conducted using a Back Scratch Test - a part of the Fullerton Functional Fitness Test. Performed in a standing position. The participant attempted to touch the middle fingers of both hands behind the back using a 30 cm ruler. One arm was positioned over the shoulder, reaching down the middle of the back with the elbow pointing outward, while the other arm reaches up from below. The distance between the fingertips was measured to assess flexibility.
Measured: 76 days
Physical fitness assessment - lower body strength
The assessment was conducted using Chair Stand Test - a part of the Fullerton Functional Fitness Test. The participant sited on a chair with arms crossed over the chest. Upon the "start" signal, they stand up fully and then sit back down. The number of complete stands performed within 30 seconds was recorded.
Measured: 76 days
Physical fitness assessment - lower body flexibility
The assessment was conducted using Chair Sit-and-Reach Test - a part of the Fullerton Functional Fitness Test. While sitting on the edge of a chair, the participant extended one leg straight forward with the heel resting on the floor. Keeping the back straight and arms extended toward the toes, they lean forward as far as possible, attempting to reach their toes. The distance between the fingertips and toes was measured to assess lower body flexibility.
Measured: 76 days
Physical fitness assessment - speed, agility, and balance
The assessment was conducted using 8-Foot Up-and-Go Test - a part of the Fullerton Functional Fitness Test. The participant started seated in a chair. Upon the "start" signal, they stand up, walk as quickly as possible to a marker placed 2.44 meters (8 feet) away, turn around, return to the chair, and sit down. The time taken to complete the task was recorded, assessing agility and dynamic balance.
Measured: 76 days
Physical fitness assessment - aerobic endurance
The assessment was conducted using 2-Minute Step Test - a part of the Fullerton Functional Fitness Test. The participant marched in place for two minutes, lifting their knees to a height midway between the kneecap and hip. The number of times the right knee was raised is counted, providing an estimate of aerobic endurance.
Measured: 76 days
Lifestyle and biological assessments - oral microbiota
For assess oral microbiota, the oral swabs were collected by qualified medical personnel. Biochemical identification of bacterial species present in the oral cavity, including Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Leptotrichia buccalis, and Propionibacterium ssp., were conducted using API biochemical strip tests.
Measured: 76 days
Lifestyle and biological assessments - laboratory tests
The laboratory tests included blood morphology and biochemical analysis (lipid profile, glucose level and C-reactive protein concentration). The assessment were conducted using standard analyses in the diagnostic laboratory.
Measured: 76 days
Lifestyle and biological assessments - adherence to healthy eating principles
The adherence to healthy eating principles was performed via nursing home menus evaluation and using the Healthy Diet Index (HDI). HDI was expressed in point scale.
Measured: 76 days
Lifestyle and biological assessments - compliance with dietary recommendations
The compliance with dietary recommendations was performed via nursing home menus evaluation and using the Healthy Eating Index (HEI). HEI was expressed in point scale.
Measured: 76 days
Lifestyle and biological assessments - quantitative diet analysis
A quantitative diet evaluation determined nutrient content, including protein, fat, carbohydrates, fiber, vitamins, and minerals. The analysis was performed via nursing home menus evaluation. The diet was assessed according to nutritional standards for the older adults.
Measured: 76 days
Lifestyle and biological assessments - qualitative diet assessment
A qualitative assessment was performed via nursing menus evaluation analysis and using Food Quality Index (DQI), Starzyńska-Bielińska test, Szewczyński's classification, and Block's questionnaire. The results were expressed in point scales.
Measured: 76 days
Anthropometric data - height
Height was measured using a heightmeter in centimeters.
Measured: 76 days
Anthropometric data - weight
Weight was carried out using the InBody 120 analyzer. Body weight was measured in kg.
Measured: 76 days
Anthropometric data - body mass index
Weight and height were combined to report body mass index (BMI). BMI was expressed in kg/m^2
Measured: 76 days
Physical fitness assessment - body composition analysis
Body composition was carried out using the InBody 120 analyzer, which utilizes bioelectrical impedance analysis. This method enables an objective evaluation of muscle mass, body fat percentage, body mass index, stored energy, and water content in the body.
Measured: 76 days
Anthropometric data - body circumferences
Waist and hip circumference were measured using an electronic measuring tape in centimeters.
Measured: 76 days
Anthropometric data - skinfold thickness
Skinfold thickness was measured using a professional caliper.
Measured: 76 days
Secondary outcomes (3)
Heart ratio
To ensure the safety of older adults, heart ratio was monitored throughout each session of VR-based training. Data were collected using fitness trackers, specifically the Fitbit Charge 6, known for its accuracy in data collection during moderate physical activity.
Measured: 76 days
Energy expenditure
To ensure the safety of older adults, energy expenditure was monitored throughout each session of VR-based training. Data were collected using fitness trackers, specifically the Fitbit Charge 6, known for its accuracy in data collection during moderate physical activity.
Measured: 76 days
Saturation
To ensure the safety of the elderly, saturation was monitored during each VR-based training session. Data were collected using a fingertip pulse oximeter
Measured: 76 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start17 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Żaneta Grzywacz, The Opole University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864325
- Sponsor's protocol ID
- OpoleUofTech5
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It was decided to provide free access to the analysed data. The data will be available upon request sent to PI: z.grzywacz@po.edu.pl
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06864325
- Acronym / sponsor ID
- OpoleUofTech5
- Conditions
- Older Adults
- Keywords
- virtual reality, functional statut, quality of life, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: VR-trainingThe VR group underwent a four-week training program, with sessions held three times per week, each lasting 20 minutes. Initially, an introductory session was organized to familiarize the participants with virtual reality. Following this, the structured training program consisted of 12 sessions over the four-week period. All sessions were conducted in a seated position to ensure comfort and safety. |
| Control group | No intervention | –The control group was a passive group that do not receive any specific intervention, engaging only in the standard daily exercises provided at the nursing home. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60 or older
- signing an informed consent to participate in the study
- willingness to participate in the therapy program.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-trainingAlso: VR-gamingThe VR gaming experience is based on the commercial rhythm game Beat Saber, featuring songs by Queen with varying rhythms and tempos. Players receive visual stimuli in the form of colored square blocks and must slice them in time with the music using the corresponding right or left hand. The blocks must be cut with a lightsaber of the same color. To ensure the safety of older adults, heart rate and energy expenditure were monitored throughout each session, while oxygen saturation was assessed before and after the exercises. Participants playe the game in comfortable conditions: the game loaded directly into the headset and VR glasses synchronized with portable screens to allow monitoring and assistance if needed. Before each session, the headset was adjusted to fit the participant's head dimensions, and corrective glasses were provided if required. The VR setup included a Meta Quest 2 headset with goggles and user-friendly controllers equipped with sensors (Meta Platforms, U.S.). | Other | VR group |
Primary outcome
Own survey research
Time frame: 76 days
The study included a custom questionnaire assessing demographic data, physical activity, quality of life, diet, oral prophylaxis, existing diseases, and medications taken, administered before intervention (at the T0). A follow-up questionnaire evaluated participants' impressions of the VR intervention is conducted after intervention (T1).
Survey research - the levels of anxiety and depression
Time frame: 76 days
At both T0 and T1 time points mental health was assessed using the Hospital Anxiety and Depression Scale (HADS).
Survey research - quality of life
Time frame: 76 days
At both T0 and T1 time points quality of life was measured with the World Health Organization's short Quality of Life Scale (WHOQOL-BRIEF)
Survey research - functional ability
Time frame: 76 days
At both T0 and T1 time points a functional ability in daily life was assessed through Activities of Daily Living (ADL) according to the Katz Index.
Survey research - activities of daily living
Time frame: 76 days
At both T0 and T1 time points Instrumental Activities of Daily Living (IADL) using the Lawton Scale.
Survey research - functional independence
Time frame: 76 days
At both T0 and T1 time points a functional independence was measured with the Functional Independence Measure (FIM).
Psychomotor assessments - tests of eye-hand coordination (EHC) and attention concentration (AC),
Time frame: 76 days
The cross visual motor test using the Piórkowski apparatus (PIOR/ATB 2.0) was used to assess EHC and AC. During the test, the participant was seated comfortably in front of the apparatus with their hands positioned over the buttons. The following test pattern was used: a duration of 90 seconds, with 1-second light intervals and stimulus frequency of 90 stimuli per 90 seconds. On the device's panel, lights were illuminated in random sequences, and the participant had to respond immediately by pressing the corresponding button as quickly and accurately as possible. The device recorded the subject's movements, reaction times and errors for each light stimulus. The test was conducted over three consecutive trials and an average score was calculated for each metric.
Physical fitness assessment - grip strength measurements
Time frame: 76 days
The test was conducted in a sitting position with the forearm resting on a table and the elbow bent at a 90-degree angle, The participant clenched their hand for 3 seconds; the test was repeated 3 times. The average result was then compared to normative values for muscle strength
Physical fitness assessment - upper body strength
Time frame: 76 days
The assessment was conducted using a Arm Curl Test - a part of Fullerton Functional Fitness Test. The participant sits on a chair, holding a weight (approximately 2.27 kg for women and 3.63 kg for men) in the dominant hand. The arm was positioned downward alongside the chair, perpendicular to the floor, with the palm facing inward. Upon the "start" signal, the participant bends the elbow, lifting the weight toward the shoulder, and then returns to the starting position. The total number of correctly performed repetitions within 30 seconds was recorded.
Physical fitness assessment - shoulder flexibility
Time frame: 76 days
The assessment was conducted using a Back Scratch Test - a part of the Fullerton Functional Fitness Test. Performed in a standing position. The participant attempted to touch the middle fingers of both hands behind the back using a 30 cm ruler. One arm was positioned over the shoulder, reaching down the middle of the back with the elbow pointing outward, while the other arm reaches up from below. The distance between the fingertips was measured to assess flexibility.
Physical fitness assessment - lower body strength
Time frame: 76 days
The assessment was conducted using Chair Stand Test - a part of the Fullerton Functional Fitness Test. The participant sited on a chair with arms crossed over the chest. Upon the "start" signal, they stand up fully and then sit back down. The number of complete stands performed within 30 seconds was recorded.
Physical fitness assessment - lower body flexibility
Time frame: 76 days
The assessment was conducted using Chair Sit-and-Reach Test - a part of the Fullerton Functional Fitness Test. While sitting on the edge of a chair, the participant extended one leg straight forward with the heel resting on the floor. Keeping the back straight and arms extended toward the toes, they lean forward as far as possible, attempting to reach their toes. The distance between the fingertips and toes was measured to assess lower body flexibility.
Physical fitness assessment - speed, agility, and balance
Time frame: 76 days
The assessment was conducted using 8-Foot Up-and-Go Test - a part of the Fullerton Functional Fitness Test. The participant started seated in a chair. Upon the "start" signal, they stand up, walk as quickly as possible to a marker placed 2.44 meters (8 feet) away, turn around, return to the chair, and sit down. The time taken to complete the task was recorded, assessing agility and dynamic balance.
Physical fitness assessment - aerobic endurance
Time frame: 76 days
The assessment was conducted using 2-Minute Step Test - a part of the Fullerton Functional Fitness Test. The participant marched in place for two minutes, lifting their knees to a height midway between the kneecap and hip. The number of times the right knee was raised is counted, providing an estimate of aerobic endurance.
Lifestyle and biological assessments - oral microbiota
Time frame: 76 days
For assess oral microbiota, the oral swabs were collected by qualified medical personnel. Biochemical identification of bacterial species present in the oral cavity, including Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Leptotrichia buccalis, and Propionibacterium ssp., were conducted using API biochemical strip tests.
Lifestyle and biological assessments - laboratory tests
Time frame: 76 days
The laboratory tests included blood morphology and biochemical analysis (lipid profile, glucose level and C-reactive protein concentration). The assessment were conducted using standard analyses in the diagnostic laboratory.
Lifestyle and biological assessments - adherence to healthy eating principles
Time frame: 76 days
The adherence to healthy eating principles was performed via nursing home menus evaluation and using the Healthy Diet Index (HDI). HDI was expressed in point scale.
Lifestyle and biological assessments - compliance with dietary recommendations
Time frame: 76 days
The compliance with dietary recommendations was performed via nursing home menus evaluation and using the Healthy Eating Index (HEI). HEI was expressed in point scale.
Lifestyle and biological assessments - quantitative diet analysis
Time frame: 76 days
A quantitative diet evaluation determined nutrient content, including protein, fat, carbohydrates, fiber, vitamins, and minerals. The analysis was performed via nursing home menus evaluation. The diet was assessed according to nutritional standards for the older adults.
Lifestyle and biological assessments - qualitative diet assessment
Time frame: 76 days
A qualitative assessment was performed via nursing menus evaluation analysis and using Food Quality Index (DQI), Starzyńska-Bielińska test, Szewczyński's classification, and Block's questionnaire. The results were expressed in point scales.
Anthropometric data - height
Time frame: 76 days
Height was measured using a heightmeter in centimeters.
Anthropometric data - weight
Time frame: 76 days
Weight was carried out using the InBody 120 analyzer. Body weight was measured in kg.
Anthropometric data - body mass index
Time frame: 76 days
Weight and height were combined to report body mass index (BMI). BMI was expressed in kg/m^2
Physical fitness assessment - body composition analysis
Time frame: 76 days
Body composition was carried out using the InBody 120 analyzer, which utilizes bioelectrical impedance analysis. This method enables an objective evaluation of muscle mass, body fat percentage, body mass index, stored energy, and water content in the body.
Anthropometric data - body circumferences
Time frame: 76 days
Waist and hip circumference were measured using an electronic measuring tape in centimeters.
Anthropometric data - skinfold thickness
Time frame: 76 days
Skinfold thickness was measured using a professional caliper.
3 secondary outcomes
Heart ratio
Time frame: 76 days
Energy expenditure
Time frame: 76 days
Saturation
Time frame: 76 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Yes. It was decided to provide free access to the analysed data. The data will be available upon request sent to PI: z.grzywacz@po.edu.pl
Related trials for Older Adults
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-training in people with Older Adults, run by The Opole University of Technology at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Own survey research (time frame: 76 days). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.