Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001472561
Ethics application status
Approved
Date submitted
19/10/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Revising virtual reality programs to support healthy ageing and quality of life of the elderly
Scientific title
Revising virtual reality programs to support healthy ageing and quality of life of the elderly
Secondary ID [1] 312892 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress
 335042 0
Neurodegenaration 335043 0
Alzheimer's disease 335044 0
balance deficits 335309 0
Condition category
Condition code
Blood 331546 331546 0 0
Normal development and function of platelets and erythrocytes
Neurological 331547 331547 0 0
Neurodegenerative diseases
Inflammatory and Immune System 331548 331548 0 0
Normal development and function of the immune system
Neurological 331549 331549 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main aim of the study is to assess the influence of physical activity on the changes of postural behavior and biochemical markers level playing role in neurodegenerative diseases in older adults. The same number of active and no active participants will be randomly allocated to one of five groups to constitute homogeneous groups.

1 Group VR1: 8 training sessions of balance-based training in augmented reality (VB-Clinic)

2 Group VR2: 8 training sessions of treadmill training in augmented reality

3 Group VR3: 8 training sessions of balance-based VR training (in HMD system - helmet mounted display)

4 Group Active Control: 8 training sessions with conventional home workout (exercise book)

5 Group Passive Control: 4 weeks without any intervention

In each training group (excluding passive control group) session will last 30min with moderate intensity (60-75%HRmax)/ 2 sessions per week.



Before pre-tests all included participants will be assessed according to their physical activity level by means of ActiGraph GT1M M during 7 consecutive days and assigned as ‘active’ or ‘no active’.
All pre-tests will be performed before the intervention begins for two days and all post-tests will be performed after finishing the intervention period, also for two days.

TRAINING PROTOCOL
After pre-testing, subjects will participate in 8 sessions of balance training using virtual/augmented reality or conventional home workout. In each training group session will last 30min with moderate intensity (60-75%HRmax)/ 2 sessions per week.

Group VR1: Augmented reality balance training: During each training session, the test subjects will practice maintaining standing posture, dynamic weight transfer, standing on one leg, pivoting in different directions, trunk rotation, and stepping. Games will be tailored to the individual capabilities of the test subject by changing the parameters of the game. The training will be conducted using Virtual Balance Clinic. This VR system included two integrated devices, a 3D measurement system based on time-of-flight cameras (Kinect sensor system) and a custom made force platform (from previous project “VB-Clinic” project no. STRATEGMED3/306011/1/NCBR/2017.)

2. Group VR2: Treadmill (Win FDM-T Zebris Medical GmbH) exercise program with augmented reality: The subject's tasks will include avoiding, crossing obstacles that appear, aiming with the foot at a preset field in the path area, performing additional cognitive tasks (such as simple mathematical operations). The aim of the training is to stimulate the subjects to lengthen/shorten their stride length at a preset pace and length, higher/lower positioning of the lower limb in the pronation phase, walking at different speeds and cadences, diverting attention from balance control during gait.

Group VR3: Balance training in full immersion: In this module, participants will perform a variety of movements inspired by conventional balance exercises, such as avoiding obstacles, hitting walls and assuming certain positions, which requires the involvement of the entire body and promotes the development of coordination and agility. The training will be conducted using HTC goggles (HTC, Corporation, Taoyuan, Taiwan) and commercial game OhShape (Odders Lab, Spain).

The training sessions will take place in the Kinesiology and Biomechnic Laboratory The Jerzy Kukuczka Academy of Physical Education in Katowice, which since 2016 have been certified in quality management of the research process ISO 9001-2015 in the area of kinesiology analysis of selected elements of physical activity and designing research procedures. All training sessions will be monitored by physiotherapists or lab staff. Their task will also be to verify the correctness of the exercises being performed and ensure their safety. The intensity of the training will be recorded using a wrist heart rate monitor and Borg RPE.
Intervention code [1] 329504 0
Prevention
Comparator / control treatment
4. Active Control Group: Participants will perform twice a week, 30min conventional home workout based on “Physiotherapy in Geriatrics Exercise Atlas." (Borowicz A, Wieczorowska-Tobis K, PZWL 2023). Participants will be required to keep an activity log throughout the intervention.
5. Passive Control Group: 4 weeks without any intervention. In this group participants will be asked to maintain the same level of activity as before the experiment.
The both groups will be the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 339667 0
The level of fear of falling
Timepoint [1] 339667 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Primary outcome [2] 339668 0
Assessment of cognitive disorders indicators. It will be assessed as a composite primary outcome
Timepoint [2] 339668 0
The outcome will be assessed before intervention (baseline values) and after completion of the 4-week program.
Primary outcome [3] 339669 0
Postural control and balance capacity. It will be assessed as a composite primary outcome
Timepoint [3] 339669 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [1] 439713 0
Magnetic resonance imaging of brain. This will be assessed as a composite outcome.
Timepoint [1] 439713 0
The outcome will be assessed before intervention (baseline values) and 12 months after completion of the 4-week program.
Secondary outcome [2] 439714 0
Assessment of blood morphology.
Timepoint [2] 439714 0
After blood separation, on the same day as blood collection morphology will be assessed at baseline and after completion of the 4-week program
Secondary outcome [3] 439715 0
Assesment of prooxidant-antioxidant balance
Timepoint [3] 439715 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [4] 439717 0
Assessment of brain-derived neurotrophic factor (BDNF), pro-brain-derived neurotrophic factor (pro-BDNF). This will be assessed as a composite outcome
Timepoint [4] 439717 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [5] 439718 0
Assessment of cortisol
Timepoint [5] 439718 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [6] 439719 0
Assessment of nuclear factor kappa-light-chain-enhancer of activated B cells
Timepoint [6] 439719 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [7] 440818 0
The body structure, body composition and posture. This will be assessed as a composite outcome
Timepoint [7] 440818 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.
Secondary outcome [8] 440819 0
Postural control and balance capacity. This will be assessed as a composite outcome. This will be assessed as a composite outcome
Timepoint [8] 440819 0
The outcome will be assessed before intervention (baseline values) and after the completion of the 4-week program.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. good health status
2. age in the range of 60-80 years (women and men)
3. giving written consent to participate in the study
4. obtaining a minimum score of 27 on the Mini Mental State Examination
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
1. lack of consent to participate in the study
2. indisposition on the scheduled day of the study
3. ineligibility for MRI examination
4. health contradictions to MRI examination and collection of biological material.
5. diabetes, mental illness, neurodegenerative diseases
6. respiratory failure, respiratory diseases, active infections
7. musculoskeletal diseases that make it impossible to perform the exercise tests covered by the program
8. experiencing shortness of breath, nausea, dizziness or pain during the exercise test

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups. Allocation of the participants will be conceal using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis was performed in Statistica 13 (StatSoft, Poland) or IBM Statistics 26.0 (IBM Corporation, Ar-monk, NY, USA). The sample size was calculated using G*Power version 3.1.9.7, developed by Heinrich 60 Heine University in Düsseldorf, Germany.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26541 0
Poland
State/province [1] 26541 0

Funding & Sponsors
Funding source category [1] 317326 0
Government body
Name [1] 317326 0
Ministry of Science and Higher Education
Country [1] 317326 0
Poland
Primary sponsor type
Government body
Name
Ministry of Science and Higher Education
Address
Country
Poland
Secondary sponsor category [1] 319612 0
None
Name [1] 319612 0
Address [1] 319612 0
Country [1] 319612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316056 0
University Bioethics Committee for Scientific Research at the Academy of Physical Education in Katowice
Ethics committee address [1] 316056 0
Ethics committee country [1] 316056 0
Poland
Date submitted for ethics approval [1] 316056 0
08/04/2024
Approval date [1] 316056 0
27/06/2024
Ethics approval number [1] 316056 0
Resolution no. 1-VI/2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136638 0
Prof Aleksandra Zebrowska
Address 136638 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136638 0
Poland
Phone 136638 0
+48322075144
Fax 136638 0
Email 136638 0
a.zebrowska@awf.katowice.pl
Contact person for public queries
Name 136639 0
Sebastian Bankowski
Address 136639 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136639 0
Poland
Phone 136639 0
+48322075154
Fax 136639 0
Email 136639 0
s.bankowski@awf.katowice.pl
Contact person for scientific queries
Name 136640 0
Aleksandra Zebrowska
Address 136640 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136640 0
Poland
Phone 136640 0
+48322075144
Fax 136640 0
Email 136640 0
a.zebrowska@awf.katowice.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.