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ElderlyNCT03118414

Effects of Physical Exercise, Virtual Reality and Brain Exercise on Balance of the Elderly

A study testing Physical Exercise, Virtual Reality and Brain Exercise in people with Elderly, run by Mahidol University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study were to 1) compare balance of the elderly by Berg Balance Scale (BBS) and Timed Up and Go Test (TUG) among physical exercise, virtual reality, brain exercise and control groups after intervention, 2) compare cognitive function of the elderly by using Timed Up and Go Cognitive (TUGC) and… Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Elderly
What is being tested?
Physical Exercise, Virtual Reality and Brain Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
No sites listed yet
Study dates
10 Feb 2016to 31 Aug 2016
Phase
Interventional
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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age 65-85 years
  • MMSE score >23
  • Able to do their activities of daily living by themselves (Berthal Index (BI) sore =100)
  • No severe or unstable cardiopulmonary problem and are physically fit to perform the intervention programs by the medical notes and recommendation of the medical doctor.

Who cannot join

  • Had lower limb injuries within 6 months or marked deformity at lower limbs
  • Having severe or active arthritis
  • Having psychological problems
  • Who have been treated with lower extremity joint surgery, such as joint arthroplasty or joint fusion or amputation
  • Having neurological problems such as stroke, Parkinsonism etc.,
  • Having severe visual problem or the problem which could not be corrected by lens or glasses e.g. cataract.
  • Having symptomatic vestibular impairment (such as dizziness or vertigo during movement) and severe hearing impairment which cannot be corrected by hearing aids.
  • Having uncontrolled hypertension or diabetes.

About this study

The objectives of this study were to 1) compare balance of the elderly by Berg Balance Scale (BBS) and Timed Up and Go Test (TUG) among physical exercise, virtual reality, brain exercise and control groups after intervention, 2) compare cognitive function of the elderly by using Timed Up and Go Cognitive (TUGC) and Montreal Cognitive Assessment (MoCA) among physical exercise, virtual reality, brain exercise and control groups after intervention, 3) compare muscle strength of elderly by 5 Times Sit-To-Stand Test (5TSTST) and Hand Grip Strength (HG) among physical exercise, virtual reality, brain exercise and control groups after intervention, 4) compare fear of falling by using Fall Efficacy Scale-International (FES-I) among physical exercise, virtual reality, brain exercise and control groups after intervention, 5)investigate the perspective of exercise among physical exercise, virtual reality, brain exercise and control groups after intervention.

Read the detailed description

This study used healthy elderly participants with the age of 65-85 years. Eighty-four elderly participants were recruited by announcing the study information at the elderly homes. Sample size calculation was performed using G*Power software (G*Power version 3.1.9.2, University Kiel, Germany). To our knowledge, no study compare the effects of physical exercise, virtual reality and brain exercise on balance of the elders. Based on previous finding on the effects of virtual reality on balance of the elderly, a total of 84 participants were required at confidence level (α) of .05 and power (1-β) of 0.80. Participants who were interested in participation underwent a screening process using inclusion-exclusion criteria and receive brief information regarding the study. If they met all inclusion criteria, the consent process was performed. To ensure they understood the study, they were simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form.

After the participants provided a written informed consent, all participants filled out the information sheet and demographic data were collected. After that, age matching with range of ± 5 years and random allocation to different studies groups were done. Pretest assessment for balance by BBS and TUG, cognitive function by TUGC and MOCA, muscle strength by 5 TSTST and Hand Grip Strength (HG) and fear of falling by FES-I and perspective of exercise by questionnaires were done and recorded by blinded assessor. In this study, random allocation of the participants to different study groups; physical exercise group (PE), virtual reality group (VR), brain exercise group (BE) and control group; was done by the medical doctor and intervention was given the physical therapist from the study area which is the elderly home. All the assessments were done by the principal researcher. The assessor was blinded to reduce the bias which might come from the assessor's expectation.

After that, all the participants from intervention groups were explained and demonstrated about the respective interventions until they clearly understand about the intervention program before commencing the intervention program. The PE, VR and BE groups got their respective intervention for 30 minutes per sessions, 3 non-consecutive days per week for 8 weeks. The control group was reminded not to participate in any other exercise or intervention program except their routine daily activities for 8 weeks. Participants from PE group needed to do the 5-minute warm-up, 20-minute core content (upper and lower limb strengthening exercises and balance challenging exercises), and 5-minute cool down exercise programs. For the virtual reality group, the participants were reminded to play the game according to the program and try to get as high a score as possible they can. This intervention program included 10 games. The participants were asked to choose 6 games from the list before each 30-minute session, and were asked to choose the games to include the upper limbs, lower limbs, and also for both strength and balance challenges instead of choosing the games that need to use only upper limbs or lower limbs, and were just for strength and balance gain. For the brain exercise, participants needed to play cognitive stimulating games; Chinese Checker, Jenga and Memory Matched pair game; in the sitting position. The participants needed to paly 10 minutes for each game and total duration for all 3 games was about 30 minutes. After 8-week study period, post-test assessments were done to find out the effect of interventions.

The statistical analyses were performed by using SPSS for windows version 18.0, statistical software package. The value of p<0.05 was considered to indicate statistical significance. As the objective of this study was to find out the effects of PE, VR and BE on balance, cognitive function, muscle strength and fear of falling in the elderly. Two-way mixed ANOVA was used to test the variance differences among the four groups with post-hoc analysis as appropriately. Prior to utilization of statistical tests, descriptive statistics were performed and statistical assumptions were tested. Transformation will be performed if the data were not normally distributed. Appropriate statistical tests (parametric vs. non-parametric) were performed to determine the effects of different interventions in this study on balance, cognitive function, muscle strength and fear of falling in the elderly. Post-hoc power analysis was also performed.

Conditions
Elderly
Being tested
Physical Exercise, Virtual Reality, Brain Exercise
Keywords
Balance, Cognition, Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ExerciseOther

    Participants were trained by exercise program based on their initial muscle strength and balance condition.

    They received a 30-minute exercise for 3sessions per week for 8 weeks in this study.

  • Virtual RealityOther

    Participants were trained with the guidance of VR system.The participants will be asked to choose 6 games from the list before each 30-minute session, and were asked to choose the games to include the upper limbs, lower limbs, and also for both strength and balance challenges instead of choosing the games that need to use only upper limbs or lower limbs, and only for strength or balance gain.

    They received a 30-minute exercise for 3sessions per week for 8 weeks in this study.

  • Brain ExerciseOther

    Brain Exercise (BE) BE stimulates the executive function, planning, concentration, visual memory and eye-hand co-ordination of the participants throughout the training.For the brain exercise, participants needed to play cognitive stimulating games; Chinese Checker, Janga and Memory Matched pair game; in the sitting position. The participants needed to paly 10 minutes for each gamed and total duration of all 3 games was about 30 minutes in each session for 3sessions per week for 8 weeks in this study.

Study groups in NCT03118414
Study groupRoleWhat they receive
Physical Exercise GroupExperimentalPhysical Exercise (PE) is an intervention that aim to improve balance and muscle strength of the elders. It composed of 3 steps; warming up exercise, core content of the exercise (strength and balance training) and cool down exercise program.
Receives: Other: Physical Exercise
Virtual RealityExperimentalVirtual Reality (VR) VR is an intervention that aim to improve balance of the elders. It stimulates the auditory and visual function and concentration of the participants throughout the training. It composed of 10 games that included weight shifting from side to side, stepping into different directions, trunk flexion, extension and side bending, movements of the upper and lower limbs, and trunk twisting in this study.
Receives: Other: Virtual Reality
Brain ExerciseExperimentalBrain Exercise (BE) BE is an intervention that aim to stimulate the cognitive function of the elders. It stimulates the executive function, planning, concentration, visual memory and eye-hand co-ordination of the participants throughout the training
Receives: Other: Brain Exercise
Control GroupNo interventionNo Intervention: Healthy control No intervention was given to this group of participants. The control group was reminded not to participate in any other exercise or intervention program except their routine daily activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance

    Berg Balance Scale was used to measure functional balance. 14-item scale designed to measure balance of the older adult in a clinical setting.

    Description:

    Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level.

    Total Score = 56 Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk

    Measured: 8 weeks

Secondary outcomes (7)
  1. Perceptive of Exercise

    Perspective of Exercise by Questionaries. The rating consisted of 6 scales; number 1 represents the least and number 6 represents the most satisfactory, beneficial or happy.

    Measured: At the end of 8-week intervention

  2. Cognition

    Montreal Cognitive Assessment to assess cognitive function of the elders.

    Description:

    Total score=30 Interpretation: >26/30 = normal cognition

    Measured: 8 weeks

  3. Lower Limb Muscle Strength

    5 Times Sit To Stand Test to measure lower limb muscle strength. The participant to sit with the back against the back of the chair and with his/her arms crossed over the chest. Then, the participant was instructed to stand up and sit down as quickly and safely as he/she can without using the arms. Time taken (in seconds) to accomplished the task is recorded by stop watch. The shorter time reflect the better performance.

    Measured: 8 weeks

  4. Fear of falling

    Fall Efficacy Scale-International to assess fear of falling of the elderly16-item scale designed to measure fear of falling of the older adult Scoring: A four-point scale, ranging from 1-4. 1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned, 4 = very concerned.' Total Score = 64 Interpretation: 16-19 = low concern 20-27 = moderate concern 28-64 = high concern

    Measured: 8 weeks

  5. Mobility Balance

    Timed up and Go test to assess the mobility balance. Get up from the chair and walk at a comfortable and safe pace to a line on the floor 3 meters away, turn, return to the chair and sit down again.

    Time taken (in seconds) to accomplished the task is recorded. The shorter time to accomplished reflect the better performance.

    Measured: 8 weeks

  6. Cognitive Function (Dual Task)

    Timed up and Go Cognitive to assess cognitive function of the elders. Get up from the chair and walk at a comfortable and safe pace to a line on the floor 3 meters away, turn, return to the chair and sit down again while counting backward by threes from a randomly selected number between 20 and 100. Time taken (in seconds) to accomplished the task is recorded by stop watch. The shorter time reflect the better performance.

    Measured: 8 weeks

  7. General Muscle Strength

    Hand grip strength to measure general muscle strength. The participant need to squeeze the dynamometer with the maximum effort and hold for 3 seconds without moving other parts of the body. The researcher read and noted down the strength of the hand grip in kilograms.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start10 Feb 2016
  3. Primary completion31 Aug 2016
  4. Study completion31 Aug 2016

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03118414
Sponsor's protocol ID
8.2.2016
Status last verified
Apr 2017
First submitted
31 Mar 2017
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miller KL, Magel JR, Hayes JG. The effects of a home-based exercise program on balance confidence, balance performance, and gait in debilitated, ambulatory community-dwelling older adults: a pilot study. J Geriatr Phys Ther. 2010 Apr-Jun;33(2):85-91.

    PubMed 20718388
  • Lee S, Shin S. Effectiveness of virtual reality using video gaming technology in elderly adults with diabetes mellitus. Diabetes Technol Ther. 2013 Jun;15(6):489-96. doi: 10.1089/dia.2013.0050. Epub 2013 Apr 5.

    PubMed 23560480
  • Lee YM, Jang C, Bak IH, Yoon JS. Effects of Computer-assisted Cognitive Rehabilitation Training on the Cognition and Static Balance of the Elderly. J Phys Ther Sci. 2013 Nov;25(11):1475-7. doi: 10.1589/jpts.25.1475. Epub 2013 Dec 11.

    PubMed 24396214

Questions about this trial

What is this clinical trial studying?

A study testing Physical Exercise, Virtual Reality and Brain Exercise in people with Elderly, run by Mahidol University.

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 8 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 18 Apr 2017. 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.

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?

Balance (time frame: 8 weeks). 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 NCT03118414, which also lists 3 linked publications.

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 18 Apr 2017.

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