Accidental FallsPhase 2FITTNCT02778841
Effects of Exergame, Conventional Exercise, and Mixed Exercise On Proprioception, Balance, & Mobility on Males Elderly
A Phase 2 study testing Exercise in people with Accidental Falls, run by Universiti Putra Malaysia.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Accidental Falls
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise or intervention
This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
| Study group | Role | What they receive |
|---|---|---|
| XBox Kinact Exercise | Experimental | Kinact game intervention group performed three times per week on non-consecutive days for eight weeks Receives: Other: Exercise |
| conventional balance exercises | Experimental | conventional balance exercises group performed three times per week on non-consecutive days for eight weeks Receives: 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 Receives: Other: Exercise |
| control Group | No intervention | There is no exercise for this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At eight weeks
Secondary outcomes (2)
Time Up and Go Test (TUG)
Time Up and Go Test, were conducted to measure functional mobility before and after exercise protocol
Measured: At Eight Weeks
10 meter walking test
10 meter walking test was used to measure functional mobility before and after exercise protocol.
Measured: At Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Principal investigator, Hassan Sadeghi, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778841
- Sponsor's protocol ID
- FPSK(EX14)P031(FR14)
- Acronym
- FITT
- Status last verified
- May 2016
- First submitted
- 17 Dec 2015
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: I am not prefer to share data now
Publications
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.
PubMed 33583253
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kinect Game ™ Exercise, Conventional Balance Exercise, and Concurrent Exercise On Knee Proprioception, Balance, And Functional Mobility on Males Elderly
- ClinicalTrials.gov ID
- NCT02778841
- Acronym / sponsor ID
- FITT / FPSK(EX14)P031(FR14)
- Conditions
- Accidental Falls
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XBox Kinact Exercise | Experimental | Other: ExerciseKinact game intervention group performed three times per week on non-consecutive days for eight weeks |
| conventional balance exercises | Experimental | Other: Exerciseconventional balance exercises group performed three times per week on non-consecutive days for eight weeks |
| concurrent exercise group | Experimental | Other: ExerciseConcurrent group performed mixed conventional balance and Xbox Kinact exercises three times per week on non-consecutive days for eight weeks |
| control Group | No intervention | –There is no exercise for this group |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Exercise or interventionThis study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly | Other | XBox Kinact Exercise, concurrent exercise group, conventional balance exercises |
Primary outcome
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.
2 secondary outcomes
Time Up and Go Test (TUG)
Time frame: At Eight Weeks
10 meter walking test
Time frame: At Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Derived from this study: PubMed 33583253Sadeghi 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.
- Individual participant dataSharing planned: No. I am not prefer to share data now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Accidental Falls, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee joint position sense (time frame: At Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.