NCT01830634

Brief Summary

Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

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

June 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

April 10, 2013

Last Update Submit

January 29, 2020

Conditions

Accidental Falls

Keywords

Community-dwelling elderlyRehabilitationTherabandStrengthening and stretching exercise

Outcome Measures

Primary Outcomes (1)

  • Computerized balance evaluation

    computerized balance and gait evaluation by a posturography and gait analysis system

    after 3 months intervention

Secondary Outcomes (1)

  • improve in functional activity

    after 3 months intervention

Study Arms (1)

Theraband with strengthening and stretching exercise

EXPERIMENTAL

All subjects were received theraband exercises (strengthening and stretching), and then compare the measured outcomes between groups.

Behavioral: Theraband with strengthening and stretching exercise

Interventions

Theraband with strengthening and stretching exerciseBEHAVIORAL

Using the theraband for strengthening and stretching the upper and lower extremity muscles. All exercises were performed by using a Theraband in the following movements: shoulder elevating and abducting, horizontal and oblique direction, plantar flexion, dorsi-flexion, inversion and eversion of ankle, knee extension and hip abduction. The stretching exercises were focused on the hamstring muscle and heel cord. Each movement was held for 5 seconds. The participants were instructed to perform 5-10 repetitions of each movements twice per day.

Theraband with strengthening and stretching exercise

Eligibility Criteria

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

You may qualify if:

  • elder living in community
  • age \> 65 years old

You may not qualify if:

  • no walking ability before fall
  • conscious change or disease induce fall
  • impaired cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital Taiwan

Changhua, 500, Taiwan

Location

Study Officials

  • TaSen Wei

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

June 1, 2005

Primary Completion

January 1, 2006

Study Completion

July 1, 2006

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

TW(1)