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

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ClinicalTrials.gov Identifier: NCT03118414
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Thwe Zar Chi Htut, Mahidol University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Elderly Other: Physical Exercise Other: Virtual Reality Other: Brain Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Physical Exercise, Virtual Reality and Brain Exercise on Balance of the Elderly
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Exercise Group
Physical 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.
Other: Physical Exercise

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.


Experimental: Virtual Reality
Virtual 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.
Other: Virtual Reality

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.


Experimental: Brain Exercise

Brain 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

Other: Brain Exercise
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.

No Intervention: Control Group
No 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.



Primary Outcome Measures :
  1. Balance [ Time Frame: 8 weeks ]

    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



Secondary Outcome Measures :
  1. Perceptive of Exercise [ Time Frame: At the end of 8-week intervention ]
    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.

  2. Cognition [ Time Frame: 8 weeks ]

    Montreal Cognitive Assessment to assess cognitive function of the elders.

    Description:

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


  3. Lower Limb Muscle Strength [ Time Frame: 8 weeks ]
    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.

  4. Fear of falling [ Time Frame: 8 weeks ]
    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

  5. Mobility Balance [ Time Frame: 8 weeks ]

    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.


  6. Cognitive Function (Dual Task) [ Time Frame: 8 weeks ]
    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.

  7. General Muscle Strength [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118414


Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Thwe Zar Chi Htut, PhDcandidate Mahidol University

Publications:
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Responsible Party: Thwe Zar Chi Htut, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03118414     History of Changes
Other Study ID Numbers: 8.2.2016
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thwe Zar Chi Htut, Mahidol University:
Balance
Cognition
Exercise