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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis Fracture
• Intervention / Treatment: Behavioral: ICG; Behavioral: MTG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG- integrated care group; Integraded Care Group	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.
Experimental: MTG- muscle training group; Muscle Traing Group	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund
• Investigators: Principal Investigator: Ding-Cheng Chan, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimated): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Posture; sarcopenia; Fracture; Spine curve
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: 201604037RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO