AgingNCT04352543
Active Video Game on Metabolic, Cardiovascular, and Psychological Metrics in Older Adults
A study testing Active Video Game Exercise, Treadmill walking exercise and Sedentary Behavior in people with Aging, run by Universidade Federal de Goias at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Active Video Game Exercise, Treadmill walking exercise and Sedentary Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2020to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 60 years
- Mini-mental score ≥ 24
- non-smoker
- no beta-blockers
- no cardiovascular risk
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic, Cardiovascular and Psychological Responses to Active Video Game in Older Adults
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.
- Conditions
- Aging
- Being tested
- Active Video Game Exercise, Treadmill walking exercise, Sedentary Behavior
- Keywords
- physical activity, active video game, older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Video Game ExerciseBehavioural
Play during 30 minutes in the easy level
Treadmill walking exerciseBehavioural
30 minutes (65 - 75% heart rate maximal)
Sedentary BehaviorBehavioural
Quiet Rest: 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Older adults group | Experimental | Group of older adults >60 years old. Receives: Behavioral: Active Video Game Exercise; Behavioral: Treadmill walking exercise; Behavioral: Sedentary Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: 5 min before, and 5 and 20 minutes following exercise
Secondary outcomes (20)
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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).
Measured: baseline
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.
Measured: baseline
Medical Screening
Clinical evaluation - patient's health history is registered. Previous disorders.
Measured: baseline
Cardiopulmonary exercise testing
Bruce Protocol by FitMateTM Pro (Cosmed, Italy) will be used to obtain VO2max
Measured: baseline
Stress electrocardiogram (ECG)
Bruce Protocol will be used. The exam will report the presence or absence of cardiovascular disease (exclusion criteria of the study)
Measured: baseline
Anthropometric Evaluation
BMI
Measured: baseline
Evaluation of Resting Metabolic Rate
Energy cost by FitMateTM Pro (Cosmed, Italy)
Measured: baseline
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.
Measured: baseline
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
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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).
Measured: baseline
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).
Measured: baseline
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).
Measured: baseline
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)
Measured: baseline
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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start20 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Soares Passos, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352543
- Sponsor's protocol ID
- 2.750.982
- Status last verified
- Nov 2020
- First submitted
- 18 Mar 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferreira JA, Passos GS, Youngstedt SD, de Lima BE, Vieira LB, Martins MM, de Assis BP, Santana MG. Are there sex differences in energy expenditure and enjoyment in older adults playing active video games? J Bodyw Mov Ther. 2022 Jul;31:72-76. doi: 10.1016/j.jbmt.2022.04.008. Epub 2022 Apr 19.
PubMed 35710225
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Cardiovascular and Psychological Responses to Active Video Game in Older Adults
- ClinicalTrials.gov ID
- NCT04352543
- Acronym / sponsor ID
- 2.750.982
- Conditions
- Aging
- Keywords
- physical activity, active video game, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults group | Experimental | Behavioral: Active Video Game Exercise, Behavioral: Treadmill walking exercise, Behavioral: Sedentary BehaviorGroup of older adults >60 years old. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 60 years
- Mini-mental score ≥ 24
- non-smoker
- no beta-blockers
- no cardiovascular risk
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Video Game ExercisePlay during 30 minutes in the easy level | Behavioural | Older adults group |
| Treadmill walking exercise30 minutes (65 - 75% heart rate maximal) | Behavioural | Older adults group |
| Sedentary BehaviorQuiet Rest: 30 minutes | Behavioural | Older adults group |
Primary outcome
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.
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
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.
20 secondary outcomes
Assess of Dementia
Time frame: baseline
Evaluation of habitual physical activity
Time frame: baseline
Evaluation of Quality of Life
Time frame: baseline
Evaluation of depression
Time frame: baseline
Evaluation of Anxiety trait
Time frame: baseline
Medical Screening
Time frame: baseline
Cardiopulmonary exercise testing
Time frame: baseline
Stress electrocardiogram (ECG)
Time frame: baseline
Anthropometric Evaluation
Time frame: baseline
Evaluation of Resting Metabolic Rate
Time frame: baseline
Anxiety symptoms
Time frame: baseline
6-Min Walk Test
Time frame: baseline
8-ft Timed Up & Go Test (TUG)
Time frame: baseline
Chair-Stand Test (CS)
Time frame: baseline
Chair sit-and-reach Test
Time frame: baseline
Metabolic assessment - Energy cost (joules/min)
Time frame: baseline
Heart rate (bpm)
Time frame: baseline
VO2 (ml/kg/min)
Time frame: baseline
Evaluation of Enjoyment
Time frame: baseline
Subjective perceived exertion
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 35710225Ferreira JA, Passos GS, Youngstedt SD, de Lima BE, Vieira LB, Martins MM, de Assis BP, Santana MG. Are there sex differences in energy expenditure and enjoyment in older adults playing active video games? J Bodyw Mov Ther. 2022 Jul;31:72-76. doi: 10.1016/j.jbmt.2022.04.008. Epub 2022 Apr 19.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Video Game Exercise, Treadmill walking exercise and Sedentary Behavior in people with Aging, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.