- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692272
Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults
December 30, 2020 updated by: Giselle Soares Passos, Universidade Federal de Goias
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
(a) using psychiatric drugs or beta-blockers;
- functional limitations
- exercise regularly
(e) smoking (b) previous experience with Xbox Kinect games.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: CONTROL group
The CONTROL group did not exercise.
|
|
|
Experimental: XBOX group
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Anxiety at 6 weeks
Time Frame: up to 24 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
|
up to 24 weeks
|
|
Change from Baseline strength at 6 weeks
Time Frame: up to 24 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.
|
up to 24 weeks
|
|
Change from Baseline agility/dynamic balance at 6 weeks
Time Frame: up to 24 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.
|
up to 24 weeks
|
|
Change from Baseline aerobic endurance at 6 weeks
Time Frame: up to 24 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
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2014
Primary Completion (Actual)
February 15, 2015
Study Completion (Actual)
December 16, 2016
Study Registration Dates
First Submitted
December 24, 2020
First Submitted That Met QC Criteria
December 30, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Actual)
December 31, 2020
Last Update Submitted That Met QC Criteria
December 30, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.040.278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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