Fracture and Fall Prevention in Elderly With Osteoporosis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01733303
Collaborator
(none)
80
1
1
71
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: personalized core muscle training program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Fracture and Fall Prevention in Elderly With Osteoporosis
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Changes of torque demand to capacity ratio 6 months [Change from Baseline intorque demand to capacity ratio at 6 months]

  2. Changes of torque demand to capacity ratio at 3 months [Change from Baseline in torque demand to capacity ratio at 3 months]

  3. Change of torque demand to capacity ratio at 12months [Change from Baseline in torque demand to capacity ratio at 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital Taipei Taiwan 10055

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01733303
Other Study ID Numbers:
  • 201003065R
First Posted:
Nov 27, 2012
Last Update Posted:
Nov 27, 2012
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 27, 2012