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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118414
• Other study ID #: 8.2.2016
• Status: Completed
• Phase: N/A
• First received: March 31, 2017
• Last updated: April 17, 2017
• Start date: February 10, 2016
• Est. completion date: August 31, 2016

Study information

• Verified date: April 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Secondary	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.	At the end of 8-week intervention
Secondary	Cognition	Montreal Cognitive Assessment to assess cognitive function of the elders.; Description: Total score=30 Interpretation: >26/30 = normal cognition	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks