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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02778841
Other study ID # FPSK(EX14)P031(FR14)
Secondary ID
Status Completed
Phase Phase 2
First received December 17, 2015
Last updated May 17, 2016
Start date November 2014
Est. completion date September 2015

Study information

Verified date May 2016
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority Malaysia: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Exercise
This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universiti Putra Malaysia Shiraz University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary knee joint position sense 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 Yes
Primary One Leg stance 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 Yes
Secondary Time Up and Go Test (TUG) Time Up and Go Test, were conducted to measure functional mobility before and after exercise protocol At Eight Weeks Yes
Secondary 10 meter walking test 10 meter walking test was used to measure functional mobility before and after exercise protocol. At Eight Weeks Yes
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