NCT01733303

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

5.9 years

First QC Date

October 5, 2012

Last Update Submit

November 20, 2012

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes of torque demand to capacity ratio 6 months

    Change from Baseline intorque demand to capacity ratio at 6 months

  • Changes of torque demand to capacity ratio at 3 months

    Change from Baseline in torque demand to capacity ratio at 3 months

  • Change of torque demand to capacity ratio at 12months

    Change from Baseline in torque demand to capacity ratio at 12 months

Study Arms (1)

Exercise

EXPERIMENTAL

Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.

Behavioral: personalized core muscle training program

Interventions

Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. The program will run for 3 months with patients attending for one hour three times a week. The age-matched control group will maintain their usual daily life activities without any specific instruction. The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.

Exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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.
  • able to stand and walk for 5 minutes independently;
  • having normal or corrected to normal vision;
  • having age between \> 50 years
  • without osteopenia or osteoporosis (t-score \> -1.0).
  • being pregnant;
  • sensory-motor deficits;
  • inability of communication
  • lack of access to a telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital

Taipei, Taiwan, 10055, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Weili Hsu, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Hsu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

November 27, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations