NCT01844154

Brief Summary

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

October 5, 2012

Last Update Submit

March 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle activation during balance recovery

    Data collection will be carried out in 2 sessions in 2 different days within the span of a week. The first day of data collection includes basic information, anthropometric measure, clinical tests, and functional tests. The second day of data collection includes muscle and joint assessment, and biomechanical tests. Each session last approximately 2.5 hours in duration.

    every 3 month, up to 1 year

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5)

You may qualify if:

  • able to stand and walk for 5 minutes independently
  • having normal or corrected to normal vision
  • having age between \> 50 years
  • already have DEXA and X-ray exam with osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5)

You may not qualify if:

  • being pregnant
  • sensory-motor deficits
  • inability of communication
  • lack of access to a telephone
  • t-score \<-2.5 combine with existing fracture
  • control age-matched group:
  • able to stand and walk for 5 minutes independently
  • having normal or corrected to normal vision
  • having age between \> 50 years
  • already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score \> -1.0)
  • being pregnant
  • sensory-motor deficits
  • inability of communication
  • lack of access to a telephone
  • t-score \<-2.5 combine with existing fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University

Taipei, Taiwan, 100, Taiwan

RECRUITING

School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wei-Li Hsu, PT,PhD

    School of physical therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Li Hsu, PT,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

May 1, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations