Fracture and Fall Prevention in Elderly With Osteoporosis

November 20, 2012 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 10055
        • Recruiting
        • Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

The inclusion criteria for osteopenia or osteoporosis group:

  1. able to stand and walk for 5 minutes independently;
  2. having normal or corrected to normal vision;
  3. having age between > 50 years
  4. with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5).

The exclusion criteria for osteopenia or osteoporosis group:

  1. being pregnant;
  2. sensory-motor deficits;
  3. inability of communication
  4. lack of access to a telephone.

The inclusion criteria for control age-matched group:

  1. able to stand and walk for 5 minutes independently;
  2. having normal or corrected to normal vision;
  3. having age between > 50 years
  4. without osteopenia or osteoporosis (t-score > -1.0).

The exclusion criteria for control age-matched group:

  1. being pregnant;
  2. sensory-motor deficits;
  3. inability of communication
  4. lack of access to a telephone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of torque demand to capacity ratio 6 months
Time Frame: Change from Baseline intorque demand to capacity ratio at 6 months
Change from Baseline intorque demand to capacity ratio at 6 months
Changes of torque demand to capacity ratio at 3 months
Time Frame: Change from Baseline in 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
Time Frame: Change from Baseline in torque demand to capacity ratio at 12 months
Change from Baseline in torque demand to capacity ratio at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Weili Hsu, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 20, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 201003065R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on personalized core muscle training program

3
Subscribe