Clinical trial NCT03118414: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Balance
Cognition
Exercise
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Balance
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceptive of Exercise
timeFrame: At the end of 8-week intervention
measure: Cognition
timeFrame: 8 weeks
measure: Lower Limb Muscle Strength
timeFrame: 8 weeks
measure: Fear of falling
timeFrame: 8 weeks
measure: Mobility Balance
timeFrame: 8 weeks
measure: Cognitive Function (Dual Task)
timeFrame: 8 weeks
measure: General Muscle Strength
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Thwe Zar Chi Htut, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.