Augmented Reality Exercise ProgramNCT06549140
Effects of an Augmented Reality Exercise Program in Older Adults
A study testing Augmented reality exercise program and Traditional exercise program in people with Augmented Reality Exercise Program and Traditional Exercise Program, run by Universidade da Madeira.
Trial summary
This research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory). Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Augmented Reality Exercise Program, Traditional Exercise Program, Control Group
- What is being tested?
- Augmented reality exercise program and Traditional exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Apr 2025
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of both genders
- 60 years or older
- Autonomous community-dwelling older adults
Who cannot join
- Neurological disorders
- Cognitive impairment
- Health limitations related to exercise participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of an Augmented Reality Exercise Program in Older Adults Physical Fitness and Cognitive Abilities
This research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).
- Being tested
- Augmented reality exercise program, Traditional exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality exercise programOther
Participants enrolled in an organized exercise program based on two weekly sessions of 45 to 60 minutes each for 12 weeks: one traditional session (group session) and one augmented reality (AR) session (individual session), both supervised by sports and exercise professionals. The AR session was designed to provide an entire exercise session targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).
Traditional exercise programOther
Participants enrolled in a traditional organized exercise program (group sessions) based on two weekly sessions of 45 to 60 minutes each for 12 weeks. These sessions are supervised by sports and exercise professionals, targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time and decision-making).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants were not enrolled in organized exercise programs during the study (12 weeks). |
| Traditional exercise program | Experimental | Participants enrolled in a traditional organized exercise program (group sessions) based on two weekly sessions of 45 to 60 minutes each for 12 weeks. These sessions are supervised by sports and exercise professionals, targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time and decision-making). Receives: Other: Traditional exercise program |
| Augmented reality exercise program | Experimental | Participants enrolled in an organized exercise program based on two weekly sessions of 45 to 60 minutes each for 12 weeks: one traditional session (group session) and one augmented reality (AR) session (individual session), both supervised by sports and exercise professionals. The AR session was designed to provide a full exercise session targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory). Receives: Other: Augmented reality exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness
Physical fitness will be assessed using the fitness test battery proposed by Rikli \& Jones (1999), including: 30-s chair stand test to assess lower-body strength, arm curl test to evaluate upper-body strength, back scratch test to examine upper-body flexibility, chair seat and reach test to assess lower-body flexibility, 8-foot up-and-go test to assess agility and dynamic balance, and the 6-min walk test to evaluate aerobic endurance.
Measured: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
Physical activity
Physical activity levels will be measured using accelerometry during each exercise session.
Measured: Participants enrolled in exercise programs will be monitored using accelerometry. Individual data will be collected in all exercise sessions (total of 48 sessions).
Body composition
Body composition will be evaluated using the InBody 770, which allows a hand-to-foot biolectrical analysis. Bodyweight, body fat percentage, and fat-free mass will be used for analysis.
Measured: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
Cognitive function
Participants' cognitive function will be examined through the Cognitive Telephone Screening Instrument and the Mini Mental State Examination.
Measured: The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.
Secondary outcomes (1)
SF-36 questionnaire
The SF-36 questionnaire is used to assess the participant's health status of participants. It consists of 36 items that assess physical functioning, physical performance, physical pain, emotional functioning, vitality, mental health, social functioning, and general health. The higher the score, the better the participant's health.
Measured: The assessment will be conducted at baseline and at week 13 after the intervention end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented Reality Exercise ProgramStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Élvio Rúbio Gouveia, Hildegardo Noronha, Francisco Santos, Mara Dionísio, Eva Freitas, Pedro Campos, Paulo Bala
- Responsible party
- Principal investigator, Cíntia Franca, Universidade da Madeira
- Investigators
- Élvio Gouveia, PhD, Study director, University of Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549140
- Sponsor's protocol ID
- EGAMESPRR
- Status last verified
- Jul 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Augmented Reality Exercise Program in Older Adults Physical Fitness and Cognitive Abilities
- ClinicalTrials.gov ID
- NCT06549140
- Acronym / sponsor ID
- EGAMESPRR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Élvio Rúbio Gouveia, Hildegardo Noronha, Francisco Santos, Mara Dionísio, Eva Freitas, Pedro Campos, Paulo Bala
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Aug 2024 (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 research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants were not enrolled in organized exercise programs during the study (12 weeks). |
| Traditional exercise program | Experimental | Other: Traditional exercise programParticipants enrolled in a traditional organized exercise program (group sessions) based on two weekly sessions of 45 to 60 minutes each for 12 weeks. These sessions are supervised by sports and exercise professionals, targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time and decision-making). |
| Augmented reality exercise program | Experimental | Other: Augmented reality exercise programParticipants enrolled in an organized exercise program based on two weekly sessions of 45 to 60 minutes each for 12 weeks: one traditional session (group session) and one augmented reality (AR) session (individual session), both supervised by sports and exercise professionals. The AR session was designed to provide a full exercise session targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory). |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants of both genders
- 60 years or older
- Autonomous community-dwelling older adults
Key exclusion criteria (3 listed)
- Neurological disorders
- Cognitive impairment
- Health limitations related to exercise participation
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 |
|---|---|---|
| Augmented reality exercise programParticipants enrolled in an organized exercise program based on two weekly sessions of 45 to 60 minutes each for 12 weeks: one traditional session (group session) and one augmented reality (AR) session (individual session), both supervised by sports and exercise professionals. The AR session was designed to provide an entire exercise session targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory). | Other | Augmented reality exercise program |
| Traditional exercise programParticipants enrolled in a traditional organized exercise program (group sessions) based on two weekly sessions of 45 to 60 minutes each for 12 weeks. These sessions are supervised by sports and exercise professionals, targeting physical fitness components (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time and decision-making). | Other | Traditional exercise program |
Primary outcome
Physical fitness
Time frame: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
Physical fitness will be assessed using the fitness test battery proposed by Rikli \& Jones (1999), including: 30-s chair stand test to assess lower-body strength, arm curl test to evaluate upper-body strength, back scratch test to examine upper-body flexibility, chair seat and reach test to assess lower-body flexibility, 8-foot up-and-go test to assess agility and dynamic balance, and the 6-min walk test to evaluate aerobic endurance.
Physical activity
Time frame: Participants enrolled in exercise programs will be monitored using accelerometry. Individual data will be collected in all exercise sessions (total of 48 sessions).
Physical activity levels will be measured using accelerometry during each exercise session.
Body composition
Time frame: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
Body composition will be evaluated using the InBody 770, which allows a hand-to-foot biolectrical analysis. Bodyweight, body fat percentage, and fat-free mass will be used for analysis.
Cognitive function
Time frame: The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.
Participants' cognitive function will be examined through the Cognitive Telephone Screening Instrument and the Mini Mental State Examination.
1 secondary outcome
SF-36 questionnaire
Time frame: The assessment will be conducted at baseline and at week 13 after the intervention end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
Élvio Gouveia, PhD study director
University of Madeira
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality exercise program and Traditional exercise program in people with Augmented Reality Exercise Program and Traditional Exercise Program, run by Universidade da Madeira.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cíntia França, PhD ((+351)291209400, cintia.franca@staff.uma.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness (time frame: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.). The study lists 4 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 12 Aug 2024.