Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area
Primary Purpose
Osteoporosis Fracture
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ICG
MTG
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis Fracture focused on measuring Spine curve, Posture, Fracture, sarcopenia, Exercise
Eligibility Criteria
Inclusion Criteria:
- older than 50 years of age
- 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
- having a bone mineral density test within one year period
- having the capability to understand the study and complete the study interventions
- willing to participate for the intervention and study follow ups
Exclusion Criteria:
- People younger than 50 years of age
- Could not communicate because of hearing, visual, or cognitive problems
- Unable to stand and walk unaided (walking aids are acceptable)
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ICG- integrated care group
MTG- muscle training group
Arm Description
Integraded Care Group
Muscle Traing Group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
grip strength
Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention.
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.
Full Information
NCT ID
NCT02803190
First Posted
June 3, 2016
Last Updated
November 24, 2022
Sponsor
National Taiwan University Hospital
Collaborators
Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund
1. Study Identification
Unique Protocol Identification Number
NCT02803190
Brief Title
Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area
Official Title
Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Fracture
Keywords
Spine curve, Posture, Fracture, sarcopenia, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICG- integrated care group
Arm Type
Experimental
Arm Description
Integraded Care Group
Arm Title
MTG- muscle training group
Arm Type
Experimental
Arm Description
Muscle Traing Group
Intervention Type
Behavioral
Intervention Name(s)
ICG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MTG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower extremety extensor power
Description
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.
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
appendicular skeletal muscle index
Description
Measured by bioimpedence analysis machine, before and after intervention. We will compare the statistical properties between baseline and after 12 weeks intervention.
Time Frame
baseline and 12 weeks
Title
grip strength
Description
Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention.
Time Frame
baseline and 12 weeks
Title
walking speed
Description
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.
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
older than 50 years of age
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
having a bone mineral density test within one year period
having the capability to understand the study and complete the study interventions
willing to participate for the intervention and study follow ups
Exclusion Criteria:
People younger than 50 years of age
Could not communicate because of hearing, visual, or cognitive problems
Unable to stand and walk unaided (walking aids are acceptable)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding-Cheng Chan
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area
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