NCT02778841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

December 17, 2015

Last Update Submit

May 17, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Time Up and Go Test (TUG)

    At Eight Weeks

  • 10 meter walking test

    At Eight Weeks

Study Arms (4)

XBox Kinact Exercise

EXPERIMENTAL

Kinact game intervention group performed three times per week on non-consecutive days for eight weeks

Other: Exercise

conventional balance exercises

EXPERIMENTAL

conventional balance exercises group performed three times per week on non-consecutive days for eight weeks

Other: Exercise

concurrent exercise group

EXPERIMENTAL

Concurrent group performed mixed conventional balance and Xbox Kinact exercises three times per week on non-consecutive days for eight weeks

Other: Exercise

control Group

NO INTERVENTION

There is no exercise for this group

Interventions

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

Also known as: Exercise or intervention
XBox Kinact Exerciseconcurrent exercise groupconventional balance exercises

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sadeghi H, Jehu DA, Daneshjoo A, Shakoor E, Razeghi M, Amani A, Hakim MN, Yusof A. Effects of 8 Weeks of Balance Training, Virtual Reality Training, and Combined Exercise on Lower Limb Muscle Strength, Balance, and Functional Mobility Among Older Men: A Randomized Controlled Trial. Sports Health. 2021 Nov-Dec;13(6):606-612. doi: 10.1177/1941738120986803. Epub 2021 Feb 13.

MeSH Terms

Interventions

ExerciseMethods

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Institute of Gerontology, University Putra Malaysia

Study Record Dates

First Submitted

December 17, 2015

First Posted

May 20, 2016

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

May 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

I am not prefer to share data now