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Fracture and Fall Prevention in Elderly With Osteoporosis

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01733303
First received: October 5, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis
 Behavioral: personalized core muscle training program

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fracture and Fall Prevention in Elderly With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Changes of torque demand to capacity ratio 6 months [ Time Frame: Change from Baseline intorque demand to capacity ratio at 6 months ] [ Designated as safety issue: No ]
  • Changes of torque demand to capacity ratio at 3 months [ Time Frame: Change from Baseline in torque demand to capacity ratio at 3 months ] [ Designated as safety issue: No ]
  • Change of torque demand to capacity ratio at 12months [ Time Frame: Change from Baseline in torque demand to capacity ratio at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: personalized core muscle training program
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733303

Contacts
Contact: Weili Hsu, PhD 886-2-3366-8127 wlhsu@ntu.edu.tw

Locations
Taiwan
Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10055
Contact: Weili Hsu, PhD     886-2-3366-8127     wlhsu@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Weili Hsu, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01733303     History of Changes
Other Study ID Numbers: 201003065R
Study First Received: October 5, 2012
Last Updated: November 20, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013