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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: 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).
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).
Other: 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 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade da Madeira

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Élvio Rúbio Gouveia
Hildegardo Noronha
Francisco Santos
Mara Dionísio
Eva Freitas
Pedro Campos
Paulo Bala

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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