Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

Osteoporosis Fracture Clinical Trial

Official title:

Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803190
• Other study ID #: 201604037RINB
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (BMD) maintained with different exercise programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices

Description:

The current study enrolled subjects who already participated in the 2015 study (n=109) at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in their original integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50) when possible. If target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX for enrollments. New participants are randomized into the ICG and MTG groups. Other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistance training on major muscle groups. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2023
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

1. older than 50 years of age

2. high risk as defined from one of the following criteria: score=1 on one minute osteoporosis risk questionnaire; 10 year predicted fracture risk=20% for major osteoporotic fracture or =3% for hip fracture from FRAX; fall=2 times in pass 1 year

3. having a bone mineral density test within one year period

4. having the capability to understand the study and complete the study interventions

5. willing to participate for the intervention and study follow ups

Exclusion Criteria:

1. People younger than 50 years of age

2. Could not communicate because of hearing, visual, or cognitive problems

3. Unable to stand and walk unaided (walking aids are acceptable)

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

Behavioral:
• ICG
All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with focus on central muscle groups. ICG subjects received once weekly group exercise.
• MTG
All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program on central muscle groups. MTG subjects received twice weekly machine-based resistance training on major and central muscle groups.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremety extensor power	Lower extremity extensor power is measured by isokinetic resistance equipment by a tranined research assistant with standarized protocol.; We will compare the statistical properties between baseline and after 12 weeks intervention.	baseline and 12 weeks
Secondary	appendicular skeletal muscle index	Measured by bioimpedence analysis machine, before and after intervention. We will compare the statistical properties between baseline and after 12 weeks intervention.	baseline and 12 weeks
Secondary	grip strength	Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention.	baseline and 12 weeks
Secondary	walking speed	Measured before and after intervention. Subjects are asked to walk 9 meters. The time between 2 and 7 meter mark are recorded. Walking speed is defined as meter/sec We will compare the statistical properties between baseline and after 12 weeks intervention.	baseline and 12 weeks