NCT03118414

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

March 31, 2017

Last Update Submit

April 17, 2017

Conditions

Keywords

BalanceCognitionExercise

Outcome Measures

Primary Outcomes (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

    8 weeks

Secondary Outcomes (7)

  • Perceptive of Exercise

    At the end of 8-week intervention

  • Cognition

    8 weeks

  • Lower Limb Muscle Strength

    8 weeks

  • Fear of falling

    8 weeks

  • Mobility Balance

    8 weeks

  • +2 more secondary outcomes

Study Arms (4)

Physical Exercise Group

EXPERIMENTAL

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

Virtual Reality

EXPERIMENTAL

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

Brain Exercise

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Physical Exercise Group

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.

Virtual Reality

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.

Brain Exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20718388BACKGROUND
  • 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.

    PMID: 23560480BACKGROUND
  • 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.

    PMID: 24396214BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thwe Zar Chi Htut, PhDcandidate

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 18, 2017

Study Start

February 10, 2016

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share