NCT06549140

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

August 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

August 8, 2024

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.

Secondary Outcomes (1)

  • SF-36 questionnaire

    The assessment will be conducted at baseline and at week 13 after the intervention end.

Study Arms (3)

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).

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).

Other: Augmented reality exercise program

Interventions

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).

Augmented reality 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).

Traditional exercise program

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of both genders
  • years or older
  • Autonomous community-dwelling older adults

You may not qualify if:

  • Neurological disorders
  • Cognitive impairment
  • Health limitations related to exercise participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Élvio Gouveia, PhD

    University of Madeira

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Cíntia França

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

August 12, 2024

Record last verified: 2024-07