AgingNCT05727748
Effects of an Exercise Program With Augmented Reality
A study testing Multimodal exercise with augmented reality and Multimodal exercise in people with Aging and Older Adults, run by University of Évora at 1 site in Portugal.
Trial summary
The objectives of the present research is to observe the effects of a multimodal program with augmented reality on cognition, functional fitness, quality of life, and physical activity in older people. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Older Adults
- What is being tested?
- Multimodal exercise with augmented reality and Multimodal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 3 May 2021to 25 Nov 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of both genders
- 60 years old or more
- Community-dwelling older adults living independently
- Able to walk autonomously
Who cannot join
- Having cognitive impairment
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Multimodal Program With Augmented Reality on Cognition, Functional Fitness and Physical Activity in Older Adults
The objectives of the present research is to observe the effects of a multimodal program with augmented reality on cognition, functional fitness, quality of life, and physical activity in older people.
Read the detailed description
The present investigation lasted 16 weeks. The first two weeks were for familiarization with the tests and initial assessments. This was followed by the 12-week intervention and final assessments (2 weeks).
The intervention program ran for 12 weeks with 3 sessions per week of 60 minutes each. There were three different groups: a) a control group; b) a multimodal training group that combined physical training with cognitive training; c) a multimodal training group with augmented reality.
The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. In the multimodal training group, the session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). In the multimodal training session with augmented reality, the session consisted of 6 stations, 4 stations as in the previous group and 2 stations with augmented reality. These 2 stations used the same components but through the portable exergame platform for the elderly.
During the 12 weeks, the intensity and difficulty of each exercise was increased after each session, depending on the evolution of the participants.
When forming the training groups, the participants who were not available during the intervention phase were assigned to the control group.
- Conditions
- Aging, Older Adults
- Being tested
- Multimodal exercise with augmented reality, Multimodal exercise, Control group
- Keywords
- Augmented Reality, Older adults, Exercise, Cogntion
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercise with augmented realityOther
The intervention program has a duration of 12 weeks with 3 sessions per week of 60 minutes each. The multimodal group with augmented reality was divided into 4 sub-groups. The session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). Four stations are the same of the previous group and the other 2 stations are with augmented reality. These 2 stations worked the same cognitive and physical components but through the portable exergame platform for the elderly.
Multimodal exerciseOther
The intervention program has a duration of 12 weeks with 3 sessions per week of 60 minutes each. The multimodal group was divided into 2 sub-groups. The session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed).
The session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed).
Control groupOther
The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. Receives: Other: Control group |
| Multimodal training group | Experimental | The session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). Receives: Other: Multimodal exercise |
| Multimodal training group with augmented reality | Experimental | The session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). Four stations are the same of the previous group and the other 2 stations are with augmented reality. These 2 stations worked the same cognitive and physical components but through the portable exergame platform for the elderly. Receives: Other: Multimodal exercise with augmented reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE)
Evaluates the cognitive state of the participant. The MMSE consists of 6 different domains: orientation, retention, attention and calculation; recall; language, and constructive skills. The maximum score for this test is 30 points. However, the education of the participant education is also taken into account when assigning the score.The scores for determining whether a person has cognitive impairment through the Mini-Mental State Examination (MMSE) are: cut-offs of ≤27 points or persons with >11 years of school education, ≤22 for persons ranging from 1 to 11 years of school education and ≤ 15 points for illiterate persons.
Measured: 13 weeks
Frontal assessment battery (FAB)
Evaluates executive functions, consisting of 6 tests that explore abilities that are related to the frontal lobes. At FAB, the highest score is 18, indicating the best possible performance on the test. The FAB is divided into 6 domains: Conceptualization, Mental Flexibility, Programming, Sensitivity to Interference, Inhibitory Control, and Environmental Autonomy. In each of the subdomains, the score ranges from 0 (worst performance) to 3 (best performance). The subdomains are assessed by short tasks given to the participants.
Measured: 13 weeks
Deary - Liewald reaction time task
Simple and choice reaction time
Measured: 13 weeks
Trail Making Test
Cognitive flexibility and processing speed
Measured: 13 weeks
Phonemic and semantic verbal fluency test.
The test assesses language production, non-motor processing speed, and executive functions.
In the semantic fluency task, participants had to say as many animals as possible over 60seconds. In the phonemic fluency exercise, participants were asked to list as many words starting with a specific letter as possible. The duration of the exercise was 60seconds. More words correspond to better scores.
Measured: 13 weeks
Stroop
Inhibition and resistance to interference. The stroop test consists of three different tasks, each lasting 45 seconds. In the first task, the participant had to read the words presented, and the words could be red, green, blue, and green. In the second task, participants had to say what color they were seeing (red, green, blue or green). In the last task, participants were presented with several words (red, green, blue, and green) written in different colors and were asked to list the color of ink for each word. The number of correct answers was recorded, with the number of correct answers giving the better score. For the participant to meet the normative data, they should enumerate more than 40 words/colors.
Measured: 13 weeks
Secondary outcomes (6)
Physical activity
Physical activity was measured using accelerometry. Participants wore the accelerometer on their waist for 7 days. Sedentary time, light, moderate, and vigorous physical activity were recorded. At the end, the results reflected the number of minutes per day/week.
Measured: 13 weeks
Senior Fitness Test - Rikli and Jones
This test battery evaluates: cardiorespiratory fitness, strength, endurance, flexibility, agility and balance. It consists of 6 different tests: 30-second chair stand (lower limb strength), arm curl (upper limb strength), chair sit and reach (lower limb flexibility), back scratch (upper limb flexibility), 6-minute walk (cardiorespiratory fitness), 8-foot up-ang-go (agility). For each of the tests there are normative values depending on age and gender.
Measured: 13 weeks
Body Composition
Body composition analyzer - Tanita. Tanita works with an electrical bioimpedance analysis that allows to determine body water, visceral fat, fat mass, lean mass, weight, body mass index, bone mass and muscle mass. This device generates a report that indicates whether the patient is in the healthy range or not.
Measured: 13 weeks
EQ-5D
The 5D questionnaire is used to assess quality of life. It consists of 5 dimensions, mobility, self-care, daily activities, pain, and anxiety/depression. For each dimension, there are 5 response options with a score ranging from 1 (no problem at all) to 5 (unable to do anything).
Measured: 13 weeks
SF-36
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: 13 weeks
Geriatric depression scale
The depression scale developed by Yesavage has been used to screen for depression. This scale assesses cognitive and behavioral aspects usually involved in depression in the elderly. We used the short version of the scale with 15 questions in which the responses are dichotomous. One point is assigned for responses indicating depression. Scores between 0 and 5 mean that there is no depression; between 6 and 10 mean that there is mild depression, and 11 and 15 mean that the person has severe depression.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start3 May 2021
- Primary completion24 Jan 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are three different groups: a) a control group; b) a multimodal training group that combined physical training with cognitive training; c) a multimodal training group with augmented reality.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Health Research Center, Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Soraia Daniela Pires Ferreira, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727748
- Sponsor's protocol ID
- AR_UEvora
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 14 Feb 2023
- 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 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multimodal Program With Augmented Reality on Cognition, Functional Fitness and Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT05727748
- Acronym / sponsor ID
- AR_UEvora
- Conditions
- Aging, Older Adults
- Keywords
- Augmented Reality, Older adults, Exercise, Cogntion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- Comprehensive Health Research Center, Foundation for Science and Technology, Portugal
- Study start
- 3 May 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 14 Feb 2023 (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.
The objectives of the present research is to observe the effects of a multimodal program with augmented reality on cognition, functional fitness, quality of life, and physical activity in older people.
Detailed description
The present investigation lasted 16 weeks. The first two weeks were for familiarization with the tests and initial assessments. This was followed by the 12-week intervention and final assessments (2 weeks).
The intervention program ran for 12 weeks with 3 sessions per week of 60 minutes each. There were three different groups: a) a control group; b) a multimodal training group that combined physical training with cognitive training; c) a multimodal training group with augmented reality.
The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. In the multimodal training group, the session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). In the multimodal training session with augmented reality, the session consisted of 6 stations, 4 stations as in the previous group and 2 stations with augmented reality. These 2 stations used the same components but through the portable exergame platform for the elderly.
During the 12 weeks, the intensity and difficulty of each exercise was increased after each session, depending on the evolution of the participants.
When forming the training groups, the participants who were not available during the intervention phase were assigned to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three different groups: a) a control group; b) a multimodal training group that combined physical training with cognitive training; c) a multimodal training group with augmented reality.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control groupThe control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. |
| Multimodal training group | Experimental | Other: Multimodal exerciseThe session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). |
| Multimodal training group with augmented reality | Experimental | Other: Multimodal exercise with augmented realityThe session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). Four stations are the same of the previous group and the other 2 stations are with augmented reality. These 2 stations worked the same cognitive and physical components but through the portable exergame platform for the elderly. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants of both genders
- 60 years old or more
- Community-dwelling older adults living independently
- Able to walk autonomously
Key exclusion criteria (2 listed)
- Having cognitive impairment
- Neurological disorders
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 |
|---|---|---|
| Multimodal exercise with augmented realityThe intervention program has a duration of 12 weeks with 3 sessions per week of 60 minutes each. The multimodal group with augmented reality was divided into 4 sub-groups. The session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). Four stations are the same of the previous group and the other 2 stations are with augmented reality. These 2 stations worked the same cognitive and physical components but through the portable exergame platform for the elderly. | Other | Multimodal training group with augmented reality |
| Multimodal exerciseThe intervention program has a duration of 12 weeks with 3 sessions per week of 60 minutes each. The multimodal group was divided into 2 sub-groups. The session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). The session consisted of six stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). | Other | Multimodal training group |
| Control groupThe control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. | Other | Control group |
Primary outcome
Mini Mental State Examination (MMSE)
Time frame: 13 weeks
Evaluates the cognitive state of the participant. The MMSE consists of 6 different domains: orientation, retention, attention and calculation; recall; language, and constructive skills. The maximum score for this test is 30 points. However, the education of the participant education is also taken into account when assigning the score.The scores for determining whether a person has cognitive impairment through the Mini-Mental State Examination (MMSE) are: cut-offs of ≤27 points or persons with >11 years of school education, ≤22 for persons ranging from 1 to 11 years of school education and ≤ 15 points for illiterate persons.
Frontal assessment battery (FAB)
Time frame: 13 weeks
Evaluates executive functions, consisting of 6 tests that explore abilities that are related to the frontal lobes. At FAB, the highest score is 18, indicating the best possible performance on the test. The FAB is divided into 6 domains: Conceptualization, Mental Flexibility, Programming, Sensitivity to Interference, Inhibitory Control, and Environmental Autonomy. In each of the subdomains, the score ranges from 0 (worst performance) to 3 (best performance). The subdomains are assessed by short tasks given to the participants.
Deary - Liewald reaction time task
Time frame: 13 weeks
Simple and choice reaction time
Trail Making Test
Time frame: 13 weeks
Cognitive flexibility and processing speed
Phonemic and semantic verbal fluency test.
Time frame: 13 weeks
The test assesses language production, non-motor processing speed, and executive functions. In the semantic fluency task, participants had to say as many animals as possible over 60seconds. In the phonemic fluency exercise, participants were asked to list as many words starting with a specific letter as possible. The duration of the exercise was 60seconds. More words correspond to better scores.
Stroop
Time frame: 13 weeks
Inhibition and resistance to interference. The stroop test consists of three different tasks, each lasting 45 seconds. In the first task, the participant had to read the words presented, and the words could be red, green, blue, and green. In the second task, participants had to say what color they were seeing (red, green, blue or green). In the last task, participants were presented with several words (red, green, blue, and green) written in different colors and were asked to list the color of ink for each word. The number of correct answers was recorded, with the number of correct answers giving the better score. For the participant to meet the normative data, they should enumerate more than 40 words/colors.
6 secondary outcomes
Physical activity
Time frame: 13 weeks
Senior Fitness Test - Rikli and Jones
Time frame: 13 weeks
Body Composition
Time frame: 13 weeks
EQ-5D
Time frame: 13 weeks
SF-36
Time frame: 13 weeks
Geriatric depression scale
Time frame: 13 weeks
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 14 Feb 2023.
Related trials for Aging
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Cerebello-Cortical Connectivity and Balance Adaptation in Younger and Older Adults
Aging, Postural Balance
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal exercise with augmented reality and Multimodal exercise in people with Aging and Older Adults, run by University of Évora at 1 site in Portugal.
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 4 inclusion and 2 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
Mini Mental State Examination (MMSE) (time frame: 13 weeks). The study lists 6 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 14 Feb 2023.