- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778841
Effects of Exergame, Conventional Exercise, and Mixed Exercise On Proprioception, Balance, & Mobility on Males Elderly (FITT)
Comparative Effects of Kinect Game ™ Exercise, Conventional Balance Exercise, and Concurrent Exercise On Knee Proprioception, Balance, And Functional Mobility on Males Elderly
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subjects should be 65 years old and above.
- The participants should be able to walk independently for a minimum of 10 meter.
- The participants should be able to do their daily activities such as eating, going to bathroom, and taking a shower.
- The participants should be able to do low-level balance exercise
Exclusion Criteria:
- The participants who had cognitive problems.
- The participants who could not walk and do their daily activities independently.
- The participants who have knee fracture or joint replacement.
- The participant who had regular balance exercise or resistance training in lower body in past 3 months.
- The participant who had neurological and cardiovascular problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: XBox Kinact Exercise
Kinact game intervention group performed three times per week on non-consecutive days for eight weeks
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This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
Other Names:
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Experimental: conventional balance exercises
conventional balance exercises group performed three times per week on non-consecutive days for eight weeks
|
This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
Other Names:
|
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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
|
This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
Other Names:
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No Intervention: control Group
There is no exercise for this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At Eight weeks
|
|
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.
|
At eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At Eight Weeks
|
|
10 meter walking test
Time Frame: At Eight Weeks
|
10 meter walking test was used to measure functional mobility before and after exercise protocol.
|
At Eight Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FPSK(EX14)P031(FR14)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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