- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06549140
Effects of an Augmented Reality Exercise Program in Older Adults
August 8, 2024 updated by: Cíntia Franca, Universidade da Madeira
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).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cíntia França, PhD
- Phone Number: (+351)291209400
- Email: cintia.franca@staff.uma.pt
Study Contact Backup
- Name: Francisco Santos, Mac
- Phone Number: (+351)291209400
- Email: francisco191santos@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants of both genders
- 60 years or older
- Autonomous community-dwelling older adults
Exclusion Criteria:
- Neurological disorders
- Cognitive impairment
- Health limitations related to exercise participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Participants were not enrolled in organized exercise programs during the study (12 weeks).
|
|
|
Experimental: Traditional exercise program
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).
|
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).
|
|
Experimental: Augmented reality exercise program
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
|
|
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.
|
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
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.
|
Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
|
|
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.
|
The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36 questionnaire
Time Frame: The assessment will be conducted at baseline and at week 13 after the intervention end.
|
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.
|
The assessment will be conducted at baseline and at week 13 after the intervention end.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Élvio Gouveia, PhD, University of Madeira
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
August 8, 2024
First Submitted That Met QC Criteria
August 8, 2024
First Posted (Actual)
August 12, 2024
Study Record Updates
Last Update Posted (Actual)
August 12, 2024
Last Update Submitted That Met QC Criteria
August 8, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- EGAMESPRR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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