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Effects of Exergame, Conventional Exercise, and Mixed Exercise On Proprioception, Balance, & Mobility on Males Elderly (FITT)

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ClinicalTrials.gov Identifier: NCT02778841
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Hassan Sadeghi, Universiti Putra Malaysia

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE May 20, 2016
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • knee joint position sense [ Time Frame: At Eight weeks ]
    A Biodex Isokinetic Dynamometer (Biodex 3, 20 Ramsay Rode, Shirley, New York) was used to assess the proprioception of the subjects. The knee joint proprioception was investigated at target angles 30°, 45° and 60° . participants' legs were passively moved to the target angles, their knees were held at the target position for 10 seconds, and then returned to the starting position (90˚). Then, the participants were asked to extend their knees by pushing the dynamometer lever arm toward the previously selected target angle. The mean joint positioning error of the three measurement degrees of error from the target
  • One Leg stance [ Time Frame: At eight weeks ]
    The single leg stance test or one leg stance (OLS) test was conducted to measure static balance . This test was performed in open and close eye on separate trials.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Time Up and Go Test (TUG) [ Time Frame: At Eight Weeks ]
    Time Up and Go Test, were conducted to measure functional mobility before and after exercise protocol
  • 10 meter walking test [ Time Frame: At Eight Weeks ]
    10 meter walking test was used to measure functional mobility before and after exercise protocol.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exergame, Conventional Exercise, and Mixed Exercise On Proprioception, Balance, & Mobility on Males Elderly
Official Title  ICMJE Comparative Effects of Kinect Game ™ Exercise, Conventional Balance Exercise, and Concurrent Exercise On Knee Proprioception, Balance, And Functional Mobility on Males Elderly
Brief Summary

Falling of the elderly as one of the greatest issues and major health problems among the elderly population has produced a further discussion among gerontologists and physical therapists. Moreover, they are considered as one of the major health problems among the aging population and by now around a third of 65-year-old adults fall as a minimum once a year while 6% of such falls cause fractures. Loss of the balance is the main reason for falling among the elderly. Proprioception is the sensory feedback regarding the joint position sense and movement which can accordingly lead to a decrease in the postural stability and steadiness of the elderly people. Proprioception has shown to be a risk factor for falls in older people. proprioception can be modified by physical training. Recently, exergaming, the playing of video games with body movements, has been proposed as effective strategy to deliver exercise.

Aim of study: the current research investigates the effect of 8 weeks videogame game exercise, conventional balance exercise, and a combined of the two (mixed training) on knee proprioception, static balance, and mobility of elderly male. Methodology: The study was designed as a single-blinded, randomized, controlled intervention trial. Sixty-four male ages 65 years and above were randomly assigned into an exergame group, a traditional balance exercise group, a mixed training group or a passive control group. After pretest all participant perform 8 weeks of exercise and measured the effects of the training regimens on proprioception and other functional outcomes as well as mood states in healthy older adults.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Accidental Falls
Intervention  ICMJE Other: Exercise
This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
Other Name: Exercise or intervention
Study Arms  ICMJE
  • Experimental: XBox Kinact Exercise
    Kinact game intervention group performed three times per week on non-consecutive days for eight weeks
    Intervention: Other: Exercise
  • Experimental: conventional balance exercises
    conventional balance exercises group performed three times per week on non-consecutive days for eight weeks
    Intervention: Other: Exercise
  • Experimental: concurrent exercise group
    Concurrent group performed mixed conventional balance and Xbox Kinact exercises three times per week on non-consecutive days for eight weeks
    Intervention: Other: Exercise
  • No Intervention: control Group
    There is no exercise for this group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subjects should be 65 years old and above.
  2. The participants should be able to walk independently for a minimum of 10 meter.
  3. The participants should be able to do their daily activities such as eating, going to bathroom, and taking a shower.
  4. The participants should be able to do low-level balance exercise

Exclusion Criteria:

  1. The participants who had cognitive problems.
  2. The participants who could not walk and do their daily activities independently.
  3. The participants who have knee fracture or joint replacement.
  4. The participant who had regular balance exercise or resistance training in lower body in past 3 months.
  5. The participant who had neurological and cardiovascular problem
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02778841
Other Study ID Numbers  ICMJE FPSK(EX14)P031(FR14)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: I am not prefer to share data now
Responsible Party Hassan Sadeghi, Universiti Putra Malaysia
Study Sponsor  ICMJE Universiti Putra Malaysia
Collaborators  ICMJE Shiraz University of Medical Sciences
Investigators  ICMJE Not Provided
PRS Account Universiti Putra Malaysia
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP