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

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

Tracking Information

• First Submitted Date: March 31, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: April 18, 2017
• Actual Study Start Date: February 10, 2016
• Actual Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2017)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 17, 2017)

• 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.
• Cognition [ Time Frame: 8 weeks ]
  Montreal Cognitive Assessment to assess cognitive function of the elders. Description: Total score=30 Interpretation: >26/30 = normal cognition
• 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.
• 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
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Physical Exercise, Virtual Reality and Brain Exercise on Balance of the Elderly
• Official Title: Effects of Physical Exercise, Virtual Reality and Brain Exercise on Balance of the Elderly
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Elderly

Intervention

• 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.

• 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.

• 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.

Study Arms

• 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.
  Intervention: Other: Physical Exercise
• 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.
  Intervention: Other: Virtual Reality
• 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

  Intervention: Other: Brain Exercise
• 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.

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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2017): 84
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 31, 2016
• Actual Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years to 85 Years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03118414
• Other Study ID Numbers: 8.2.2016
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Thwe Zar Chi Htut, Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thwe Zar Chi Htut, PhDcandidate; Mahidol University

• PRS Account: Mahidol University
• Verification Date: April 2017