SleepNCT04692272
Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults
A study testing Exercise in the XBOX kinect in people with Sleep and Anxiety, run by Universidade Federal de Goias.
Trial summary
The present study aims to examine the effects of Xbox Kinect exercise training program on the sleep quality, anxiety and functional capacity in older adults. Older adults were randomized into two groups. The XBOX group performed exercise with Xbox Kinect during 60 min, three times/week for 6 weeks. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Exercise in the XBOX kinect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2014to 16 Dec 2016
- 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
- ability to perform exercises with Xbox Kinect and/or physical/functional tests and to answer the questionnaires;
- score ≥ 24 on the Mini-Mental State Examination
Who cannot join
- using psychiatric drugs or beta-blockers;
- functional limitations
- exercise regularly
- smoking (b) previous experience with Xbox Kinect games.
About this study
Official title: Effects of Xbox Kinect Exercise Training on the Sleep Quality, Anxiety and Functional Capacity in Older Adults
The present study aims to examine the effects of Xbox Kinect exercise training program on the sleep quality, anxiety and functional capacity in older adults. Older adults were randomized into two groups. The XBOX group performed exercise with Xbox Kinect during 60 min, three times/week for 6 weeks. The CONTROL group did not exercise. Pittsburgh Sleep Quality Index was used to evaluate sleep quality, anxiety symptoms by the State-Trait Anxiety Inventory, and the functional capacity was analyzed using following tests: Chair Stand Test, 8-Foot Up and Go Test, and 6-min Walk Test.
- Being tested
- Exercise in the XBOX kinect
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in the XBOX kinectBehavioural
The XBOX group performed exercise for 60 min, three times/week, for 6 weeks, using the Xbox Kinect game "Your Shape Fitness evolved". This game was chosen because it simulates an environment with a variety of physical activities, in which the majority can be practiced by older adults. The activities were carried out individually. The game activities selected for the physical activity sessions were: 1) Zen-Develop it (stretching, balance and flexibility activities, similar to Yoga); 2) Pump it (to fill balls until they burst); 3) Wall Breaker (to break blocks, similar to boxing); 4) Kick it (soccer activity); 5) Hurricane (to lift the balls off the floor and not let them fall); 6) Stack in Up (balance activity).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL group | No intervention | The CONTROL group did not exercise. |
| XBOX group | Experimental | The XBOX group performed exercise for 60 min, three times/week, for 6 weeks, using the Xbox Kinect game "Your Shape Fitness evolved". This game was chosen because it simulates an environment with a variety of physical activities, in which the majority can be practiced by older adults. The activities were carried out individually. The game activities selected for the physical activity sessions were: 1) Zen-Develop it (stretching, balance and flexibility activities, similar to Yoga); 2) Pump it (to fill balls until they burst); 3) Wall Breaker (to break blocks, similar to boxing); 4) Kick it (soccer activity); 5) Hurricane (to lift the balls off the floor and not let them fall); 6) Stack in Up (balance activity). Receives: Behavioral: Exercise in the XBOX kinect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Sleep Quality at 6 weeks
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval and provides quantitative and qualitative information on sleep. The questionnaire consists of 19 self-report items and other questions. The score ranges from 0 to 21 and scores > 5 indicates the patient is a poor sleeper
Measured: up to 24 weeks
Secondary outcomes (4)
Change from Baseline Anxiety at 6 weeks
Anxiety Symptoms: State-Trait Anxiety Inventory (STAI) assesses anxiety level using two scales (State and Trait) with 20 items. Range of scores is 20-80, and the scores indicate low (0-30), medium (31-49), or high (50 or more) anxiety levels
Measured: up to 24 weeks
Change from Baseline strength at 6 weeks
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: up to 24 weeks
Change from Baseline agility/dynamic balance at 6 weeks
The 8-ft Timed Up \& Go Test is used to assess agility and dynamic balance. Participants are asked to sit on 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: up to 24 weeks
Change from Baseline aerobic endurance at 6 weeks
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: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Dec 2014
- Primary completion15 Feb 2015
- Study completion16 Dec 2016
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 SleepStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT04692272
- Sponsor's protocol ID
- 1.040.278
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evangelista de Lima B, Passos GS, Youngstedt SD, Bandeira Santos Junior LC, Goncalves Santana M. Effects of Xbox Kinect exercise training on sleep quality, anxiety and functional capacity in older adults. J Bodyw Mov Ther. 2021 Oct;28:271-275. doi: 10.1016/j.jbmt.2021.07.029. Epub 2021 Aug 6.
PubMed 34776152
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xbox Kinect Exercise Training on the Sleep Quality, Anxiety and Functional Capacity in Older Adults
- ClinicalTrials.gov ID
- NCT04692272
- Acronym / sponsor ID
- 1.040.278
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 15 Feb 2015 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 31 Dec 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 present study aims to examine the effects of Xbox Kinect exercise training program on the sleep quality, anxiety and functional capacity in older adults. Older adults were randomized into two groups. The XBOX group performed exercise with Xbox Kinect during 60 min, three times/week for 6 weeks. The CONTROL group did not exercise. Pittsburgh Sleep Quality Index was used to evaluate sleep quality, anxiety symptoms by the State-Trait Anxiety Inventory, and the functional capacity was analyzed using following tests: Chair Stand Test, 8-Foot Up and Go Test, and 6-min Walk Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL group | No intervention | –The CONTROL group did not exercise. |
| XBOX group | Experimental | Behavioral: Exercise in the XBOX kinectThe XBOX group performed exercise for 60 min, three times/week, for 6 weeks, using the Xbox Kinect game "Your Shape Fitness evolved". This game was chosen because it simulates an environment with a variety of physical activities, in which the majority can be practiced by older adults. The activities were carried out individually. The game activities selected for the physical activity sessions were: 1) Zen-Develop it (stretching, balance and flexibility activities, similar to Yoga); 2) Pump it (to fill balls until they burst); 3) Wall Breaker (to break blocks, similar to boxing); 4) Kick it (soccer activity); 5) Hurricane (to lift the balls off the floor and not let them fall); 6) Stack in Up (balance activity). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to perform exercises with Xbox Kinect and/or physical/functional tests and to answer the questionnaires;
- score ≥ 24 on the Mini-Mental State Examination
Key exclusion criteria (4 listed)
- using psychiatric drugs or beta-blockers;
- functional limitations
- exercise regularly
- smoking (b) previous experience with Xbox Kinect games.
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 |
|---|---|---|
| Exercise in the XBOX kinectThe XBOX group performed exercise for 60 min, three times/week, for 6 weeks, using the Xbox Kinect game "Your Shape Fitness evolved". This game was chosen because it simulates an environment with a variety of physical activities, in which the majority can be practiced by older adults. The activities were carried out individually. The game activities selected for the physical activity sessions were: 1) Zen-Develop it (stretching, balance and flexibility activities, similar to Yoga); 2) Pump it (to fill balls until they burst); 3) Wall Breaker (to break blocks, similar to boxing); 4) Kick it (soccer activity); 5) Hurricane (to lift the balls off the floor and not let them fall); 6) Stack in Up (balance activity). | Behavioural | XBOX group |
Primary outcome
Change from Baseline Sleep Quality at 6 weeks
Time frame: up to 24 weeks
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval and provides quantitative and qualitative information on sleep. The questionnaire consists of 19 self-report items and other questions. The score ranges from 0 to 21 and scores > 5 indicates the patient is a poor sleeper
4 secondary outcomes
Change from Baseline Anxiety at 6 weeks
Time frame: up to 24 weeks
Change from Baseline strength at 6 weeks
Time frame: up to 24 weeks
Change from Baseline agility/dynamic balance at 6 weeks
Time frame: up to 24 weeks
Change from Baseline aerobic endurance at 6 weeks
Time frame: up to 24 weeks
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 31 Dec 2020.
- Derived from this study: PubMed 34776152Evangelista de Lima B, Passos GS, Youngstedt SD, Bandeira Santos Junior LC, Goncalves Santana M. Effects of Xbox Kinect exercise training on sleep quality, anxiety and functional capacity in older adults. J Bodyw Mov Ther. 2021 Oct;28:271-275. doi: 10.1016/j.jbmt.2021.07.029. Epub 2021 Aug 6.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in the XBOX kinect in people with Sleep and Anxiety, run by Universidade Federal de Goias.
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 2 inclusion and 4 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Sleep Quality at 6 weeks (time frame: up to 24 weeks). 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 NCT04692272, 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 31 Dec 2020.