- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352543
Active Video Game on Metabolic, Cardiovascular, and Psychological Metrics in Older Adults
Metabolic, Cardiovascular and Psychological Responses to Active Video Game in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Goias
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Jataí, Goias, Brazil, 75803495
- UFG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 60 years
- Mini-mental score ≥ 24
- non-smoker
- no beta-blockers
- no cardiovascular risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Older adults group
Group of older adults >60 years old.
|
Play during 30 minutes in the easy level
30 minutes (65 - 75% heart rate maximal)
Quiet Rest: 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Anxiety State at 5 min before, and 5 and 20 minutes following exercise
Time Frame: 5 min before, and 5 and 20 minutes following exercise
|
Anxiety Inventory-STAI trait-state. The scale encompass 20 items and provides a one-dimensional measurement. The score varies from 20 to 80 points, with scores indicating low (0-30), medium (31-49) or high (50 or more) level of anxiety. of anxiety. |
5 min before, and 5 and 20 minutes following exercise
|
Change from Baseline Mood States at 5 min before, and 5 and 20 minutes following exercise
Time Frame: 5 min before, and 5 and 20 minutes following exercise
|
Scale: Profile of mood states (POMS) The POMS questionnaire is an instrument to evaluate mood states.
It has 65 items and 6 domains: tension-anxiety, depression, anger-hostility, vigour-activity, fatigue, and confusion- bewilderment.
The total mood disturbance score is derived by subtracting the vigour-activity score from the the sum of scores from the other subscales
|
5 min before, and 5 and 20 minutes following exercise
|
Change from Baseline Exercise Experience at 5 min before, and 5 and 20 minutes following exercise
Time Frame: 5 min before, and 5 and 20 minutes following exercise
|
Subjective Exercise Experiences Scale - SEES is a set of three subscales objectives that add up to 12 adjectives in total.
A subscale well-being positive is composed of the following adjectives: great, positive, vigorous and wonderful; an anguish of the subscale psychological is composed by the adjectives lousy, diminished, discouraged and sad; while in the fatigue subscale, adjectives are: exhausted, exhausted, fatigued and tired.
Each adjective can be classified into certain intensities create scores that can range from 1 (which means "nothing") to 7 points (which means "a lot").
Of that Thus, a score on each subscale can be at least 4 and a maximum of 28 points.
|
5 min before, and 5 and 20 minutes following exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess of Dementia
Time Frame: baseline
|
Mini-Mental Scale - The MMSE is divided into five subscales (orientation, immediate memory, attention and calculation, evocation and language) and is used to screen for clinical symptoms of dementia.
The MMSE score can vary from a minimum of 0 to a maximum total of 30 points.
The cut-off point for the exam is 24 points.
|
baseline
|
Evaluation of habitual physical activity
Time Frame: baseline
|
International Physical Activity Questionnaire (IPAQ) -
|
baseline
|
Evaluation of Quality of Life
Time Frame: baseline
|
SF-36 Short-Form - The SF-36 is a multidimensional questionnaire that covers eight components: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, vitality, general health perception, body pain, and mental health.
All scores ranged from 0 to 100, with a higher score indicating better quality of life.
|
baseline
|
Evaluation of depression
Time Frame: baseline
|
15-item Geriatric Depression Scale (GDS-15) is used to assess depressive symptoms.
Participants who scored a total of 7 or more points are defined as having clinically significant depressive symptoms.
The severity of depressive symptoms are: no depression (score of 0), questionable depression (score of 1-4), mild-to-moderate depression (score of 5-9) and severe depression (score of 10-15).
|
baseline
|
Evaluation of Anxiety trait
Time Frame: baseline
|
Trait Anxiety (STAI) - The scale encompass 20 items and provides a one-dimensional measurement.
The score varies from 20 to 80 points, with scores indicating low (0-30), medium (31-49) or high (50 or more) level of anxiety.
|
baseline
|
Medical Screening
Time Frame: baseline
|
Clinical evaluation - patient's health history is registered.
Previous disorders.
|
baseline
|
Cardiopulmonary exercise testing
Time Frame: baseline
|
Bruce Protocol by FitMateTM Pro (Cosmed, Italy) will be used to obtain VO2max
|
baseline
|
Stress electrocardiogram (ECG)
Time Frame: baseline
|
Bruce Protocol will be used.
The exam will report the presence or absence of cardiovascular disease (exclusion criteria of the study)
|
baseline
|
Anthropometric Evaluation
Time Frame: baseline
|
BMI
|
baseline
|
Evaluation of Resting Metabolic Rate
Time Frame: baseline
|
Energy cost by FitMateTM Pro (Cosmed, Italy)
|
baseline
|
Anxiety symptoms
Time Frame: baseline
|
Geriatric Anxiety Inventory: The GAI is a 20-item measure of anxiety symptoms severity developed for older adults.
Scores ≥ 8 indicate the presence of anxiety symptoms.
|
baseline
|
6-Min Walk Test
Time Frame: baseline
|
The 6-MWT is performed in a 20-m-long indoor hallway free of obstacles.
Participants are instructed to walk at a self-selected regular pace to cover as much distance as they could during the allotted time.
The score is the total number of meters walked in 6 min
|
baseline
|
8-ft Timed Up & Go Test (TUG)
Time Frame: baseline
|
The 8-ft Timed Up & Go Test is used to assess agility and dynamic balance.
Participants are asked to sito n a chair.
On cue, they stood up, walked as quickly as possible around a cone set 8ft from the chair, and sat back down on the chair.
Total time to complete the test in seconds was measured to assess performance.
|
baseline
|
Chair-Stand Test (CS)
Time Frame: baseline
|
Chair Stand Test is used to assess lower body strength.
After a signal participants completed as many "stand-ups" as possible with 30s.
Total repetitions completed within 30s are used to score the participants' performance.
|
baseline
|
Chair sit-and-reach Test
Time Frame: baseline
|
Chair sit-and-reach is used to evaluate lower body flexibility.
Participants are asked to sit on the edge of a chair with the knee bent at 900 and the left foot flat on the while keeping the right knee straight and right leg extended forward.
Participants are asked to attempt to touch their toes using both hands.
The distance in inches between fingers and toes was measured and given a negative value if the fingers did not reach the toes and a positive value if fingers extended beyond the toes.
|
baseline
|
Metabolic assessment - Energy cost (joules/min)
Time Frame: baseline
|
|
baseline
|
Heart rate (bpm)
Time Frame: baseline
|
|
baseline
|
VO2 (ml/kg/min)
Time Frame: baseline
|
|
baseline
|
Evaluation of Enjoyment
Time Frame: baseline
|
PACES - consisting of five items. Each item has a score from 1 to 7 on a Likert scale. The sum of these items generates a range of scores from 5 to 35. Higher scores indicate greater enjoyment. The scores were transformed into percentage, with a score of 35 equal to 100%.
|
baseline
|
Subjective perceived exertion
Time Frame: baseline
|
The Borg Scale is used to verify the subjective perception of effort. This scale has 15 points, from 6 to 20. Each number refers to a certain intensity, so that the exercise can be classified as: no effort (6), extremely light (7), very light (8 and 9) , light (10 and 11), moderate (12 and 13), intense (14 and 15), very intense (16 and 17), extremely intense (18 and 19) and maximum effort.
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2.750.982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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