Fracture and Fall Prevention in Elderly With Osteoporosis

Osteoporosis Clinical Trial

Official title:

Fracture and Fall Prevention in Elderly With Osteoporosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01733303
• Other study ID #: 201003065R
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: November 20, 2012
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: Weili Hsu, PhD
• Phone: 886-2-3366-8127
• Email: wlhsu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of torque demand to capacity ratio 6 months		Change from Baseline intorque demand to capacity ratio at 6 months	No
Primary	Changes of torque demand to capacity ratio at 3 months		Change from Baseline in torque demand to capacity ratio at 3 months	No
Primary	Change of torque demand to capacity ratio at 12months		Change from Baseline in torque demand to capacity ratio at 12 months	No