Active Video Game on Metabolic, Cardiovascular, and Psychological Metrics in Older Adults

Aging Clinical Trial

Official title:

Metabolic, Cardiovascular and Psychological Responses to Active Video Game in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352543
• Other study ID #: 2.750.982
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Xbox Kinect seems to be a good alternative for the older adults to perform physical activities at times that are typically associated with sedentary behaviors. The Xbox Kinect active video game has been used in various parts of the world as entertainment. The study of metabolic, cardiovascular and psychological responses during these activities may bring relevant information regarding the intensity of the exercises and, consequently, about the possibility of using these games to maintain and / or improve the cardiorespiratory fitness of the older adults. In addition, the present study may clarify the responses of activities on Xbox Kinect in elderly people with anxiety and depression symptoms. Will be selected 100 older adults. All volunteers will initially perform assessments of resting metabolic rate, cardiorespiratory fitness, functional tests, as well as subjective assessments of physical activity level, anxiety and mood. Subsequently, they will perform activities with body movements on the Xbox Kinect, which will be compared with sedentary behavior activity (TV / Movie). All activities will be monitored by means of a gas analyzer, which will record information about the behavior of energy expenditure, resting heart rate and activity. In addition, assessments of perception of effort and fun during activities will be made through subjective scales. The effects of Xbox Kinect activity on anxiety symptoms and mood will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• age > 60 years

• Mini-mental score = 24

• non-smoker

• no beta-blockers

• no cardiovascular risk

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Active Video Game Exercise
Play during 30 minutes in the easy level
• Treadmill walking exercise
30 minutes (65 - 75% heart rate maximal)
• Sedentary Behavior
Quiet Rest: 30 minutes

Locations

Country	Name	City	State
Brazil	UFG	Jataí	Goias

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Anxiety State at 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
Primary	Change from Baseline Mood States at 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
Primary	Change from Baseline Exercise Experience at 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	Assess of Dementia	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
Secondary	Evaluation of habitual physical activity	International Physical Activity Questionnaire (IPAQ) -; VERY ACTIVE: one who has fulfilled recommendations from: VIGOROUS: 5 days / week and 30 minutes for session and / or; VIGOROUS: 3 days / week and 20 minutes per + MODERATE and / or WALK session: 5 days / week and 30 minutes per session.; ACTIVE: one who has followed the recommendations in: VIGOROUS: 3 days / week and 20 minutes per session; and / or; MODERATE or WALK: 5 days / week and 30 minutes per session; and / or; Any combined activity: 5 days / week and 150 minutes / week (walking + moderate + vigorous).; IRREGULATELY ACTIVE: one who performs physical activity, but insufficient to be classified as active, as it does not comply with the recommendations frequency or duration.; SEDENTARY: one who did not perform no physical activity for at least 10 minutes during the week.	baseline
Secondary	Evaluation of Quality of Life	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
Secondary	Evaluation of depression	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
Secondary	Evaluation of Anxiety trait	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
Secondary	Medical Screening	Clinical evaluation - patient's health history is registered. Previous disorders.	baseline
Secondary	Cardiopulmonary exercise testing	Bruce Protocol by FitMateTM Pro (Cosmed, Italy) will be used to obtain VO2max	baseline
Secondary	Stress electrocardiogram (ECG)	Bruce Protocol will be used. The exam will report the presence or absence of cardiovascular disease (exclusion criteria of the study)	baseline
Secondary	Anthropometric Evaluation	BMI	baseline
Secondary	Evaluation of Resting Metabolic Rate	Energy cost by FitMateTM Pro (Cosmed, Italy)	baseline
Secondary	Anxiety symptoms	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
Secondary	6-Min Walk Test	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
Secondary	8-ft Timed Up & Go Test (TUG)	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
Secondary	Chair-Stand Test (CS)	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
Secondary	Chair sit-and-reach Test	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
Secondary	Metabolic assessment - Energy cost (joules/min)	Sedentary behavior (Watching Film/TV): 10 min; Active behavior (Playing Xbox Kinect): 10 min activity by 5 min rest (5 activities)FitMateTM Pro (Cosmed, Italy).	baseline
Secondary	Heart rate (bpm)	Sedentary behavior (Watching Film/TV): 10 min; Active behavior (Playing Xbox Kinect): 10 min activity by 5 min rest (5 activities)FitMateTM Pro (Cosmed, Italy).	baseline
Secondary	VO2 (ml/kg/min)	Sedentary behavior (Watching Film/TV): 10 min; Active behavior (Playing Xbox Kinect): 10 min activity by 5 min rest (5 activities)FitMateTM Pro (Cosmed, Italy).	baseline
Secondary	Evaluation of Enjoyment	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%.; Sedentary behavior (Watching Film/TV): 10 min; Active behavior (Playing Xbox Kinect): 10 min activity by 5 min rest (5 activities)	baseline
Secondary	Subjective perceived exertion	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.; Sedentary behavior (Watching Film/TV): 10 min; Active behavior (Playing Xbox Kinect): 10 min activity by 5 min rest (5 activities)	baseline