Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05727748
Other study ID # AR_UEvora
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date November 25, 2022

Study information

Verified date February 2023
Source University of Évora
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date November 25, 2022
Est. primary completion date January 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 100 Years
Eligibility Inclusion Criteria: - Participants of both genders - 60 years old or more - Community-dwelling older adults living independently - Able to walk autonomously Exclusion Criteria: - Having cognitive impairment - Neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Multimodal exercise with augmented reality
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 exercise
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 group
The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study.

Locations

Country Name City State
Portugal Soraia Daniela Pires Ferreira Leiria

Sponsors (3)

Lead Sponsor Collaborator
University of Évora Comprehensive Health Research Centre, Foundation for Science and Technology, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Deary - Liewald reaction time task Simple and choice reaction time 13 weeks
Primary Trail Making Test Cognitive flexibility and processing speed 13 weeks
Primary 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
Primary 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 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. 13 weeks
Secondary 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. 13 weeks
Secondary 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. 13 weeks
Secondary 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). 13 weeks
Secondary 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. 13 weeks
Secondary 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. 13 weeks
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A