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Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults

Primary Purpose

Sleep, Anxiety, Aging

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise in the XBOX kinect
Sponsored by
Universidade Federal de Goias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    CONTROL group

    XBOX group

    Arm Description

    The CONTROL group did not exercise.

    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).

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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.
    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.
    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

    Full Information

    First Posted
    December 24, 2020
    Last Updated
    December 30, 2020
    Sponsor
    Universidade Federal de Goias
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04692272
    Brief Title
    Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults
    Official Title
    Effects of Xbox Kinect Exercise Training on the Sleep Quality, Anxiety and Functional Capacity in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2014 (Actual)
    Primary Completion Date
    February 15, 2015 (Actual)
    Study Completion Date
    December 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Goias

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep, Anxiety, Aging, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CONTROL group
    Arm Type
    No Intervention
    Arm Description
    The CONTROL group did not exercise.
    Arm Title
    XBOX group
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise in the XBOX kinect
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change from Baseline Sleep Quality at 6 weeks
    Description
    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
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Anxiety at 6 weeks
    Description
    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
    Time Frame
    up to 24 weeks
    Title
    Change from Baseline strength at 6 weeks
    Description
    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.
    Time Frame
    up to 24 weeks
    Title
    Change from Baseline agility/dynamic balance at 6 weeks
    Description
    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.
    Time Frame
    up to 24 weeks
    Title
    Change from Baseline aerobic endurance at 6 weeks
    Description
    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
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34776152
    Citation
    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.
    Results Reference
    derived

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    Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults

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