NCT02821091

Brief Summary

Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults. Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). The investigators will compute the joint torque during functional activates using biomechanical data from the 3-D motion analysis, whereas the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis (BIA). Clinical and functional assessments for balance performance will also be conducted. Fracture and fall history prior to the testing will be recorded retrospectively. Aim 2: Identify the relationships between force usages during balance perturbation in older adults. Lateral and forward/backward perturbation while walking will be used to elicit balance recovery responses. The degree of necessary joint force and how this relates to a person's functional capacity at specific joint levels will be determined by the torque demand to capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a joint-specific unified scalar quantity representing the balance recovery demand normalized by the maximum muscle strength capacity of an individual. It would indicate whether a person can recover balance and to what extent of his/her maximum capacity is taxed. Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized strengthening and balance training program on improving balance performance in older adults. Personalized strengthening and balance training exercise will be personalized based on the results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and split-belt balance perturbation instrumented treadmill. The exercise group will receive training 2 times a week for 2 months and the age-matched control group will maintain their usual daily life activities. All assessments will be performed at baseline, and 1 week after training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following the training period.

Trial Health

57
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Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2017

Completed
Last Updated

May 8, 2017

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 29, 2016

Last Update Submit

May 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go Test

    Up to 52 weeks

Study Arms (3)

Control young adults

NO INTERVENTION

Healthy adults, age between 20 to 59 yeas old

Control old adults

NO INTERVENTION

Healthy adults, age between 60 to 80 yeas old

Exercise old adults

EXPERIMENTAL

Healthy adults, age between 60 to 80 yeas old received interactive dynamic balance training

Other: Interactive Dynamic Balance Training

Interventions

Exercise old adults

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For control young adults group:
  • able to stand and walk for 5 minutes independently without assistant
  • aging between 20 and 59 years old
  • For older adults group:
  • able to stand and walk for 5 minutes independently without assistant
  • aging between 60 and 80 years old;

You may not qualify if:

  • pre-existing major lower-extremity pathology (e.g., Chronic ankle instability or severe osteoarthritis)
  • neurological disorders or balance difficulties (e.g., Vertigo, poor vision, dizziness, stroke, or epilepsy) that would prevent standing for the duration of the testing procedures without the aid of an assistive device
  • health conditions (e.g., Heart disease, uncontrolled hypertension, chronic obstructive pulmonary diseases) that would exclude participation in a balance exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Wei-Li Hsu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

April 16, 2015

Primary Completion

April 26, 2016

Study Completion

January 24, 2017

Last Updated

May 8, 2017

Record last verified: 2016-06

Locations