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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ability to perform exercises with Xbox Kinect and/or physical/functional tests and to answer the questionnaires;
  2. score ≥ 24 on the Mini-Mental State Examination

Exclusion Criteria:

(a) using psychiatric drugs or beta-blockers;

  1. functional limitations
  2. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Exercise in the XBOX kinect
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Goias

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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