NCT05727748

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 3, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 10, 2023

Last Update Submit

February 13, 2023

Conditions

Keywords

Augmented RealityOlder adultsExerciseCogntion

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    13 weeks

  • Deary - Liewald reaction time task

    Simple and choice reaction time

    13 weeks

  • Trail Making Test

    Cognitive flexibility and processing speed

    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.

    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.

    13 weeks

Secondary Outcomes (6)

  • Physical activity

    13 weeks

  • Senior Fitness Test - Rikli and Jones

    13 weeks

  • Body Composition

    13 weeks

  • EQ-5D

    13 weeks

  • SF-36

    13 weeks

  • +1 more secondary outcomes

Study Arms (3)

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.

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).

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.

Other: Multimodal exercise with augmented reality

Interventions

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 training group with augmented reality

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).

Multimodal training group

The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study.

Control group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of both genders
  • years old or more
  • Community-dwelling older adults living independently
  • Able to walk autonomously

You may not qualify if:

  • Having cognitive impairment
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soraia Daniela Pires Ferreira

Leiria, 2405-030, Portugal

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 14, 2023

Study Start

May 3, 2021

Primary Completion

January 24, 2022

Study Completion

November 25, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations