Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Study Overview
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Brief Summary
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OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks. MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, and coping strategy and another hour of professional led exercise program. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power at baseline and after 12-weeks of intervention.

Official Title
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Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Conditions
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Osteoporosis Fracture

Intervention / Treatment
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* Behavioral: ICG
* Behavioral: MTG
* Behavioral: XBG


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG<br>Integrated Care Group | Behavioral: ICG<br>* Core 2-hour education course including practice of study home exercise program. Weekly professional led exercise program for 90 mins at NTUHBB site with reinforcement on osteoporosis related educations and care managements from study educational booklet and CD-rom for 3-month. The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking. Subjects are encouraged to practice study home exercise program at least twice weekly.<br>|
| Experimental: MTG<br>Muscle Training Group | Behavioral: MTG<br>* MTG group subjects were invited to NTUHBB site to receive 2 sessions of 45-minute training using isotonic strength training machines on major muscle groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist<br>|
| Experimental: XBG<br>X-box Group | Behavioral: XBG<br>* XBG group subjects were invited to LCGMH site to receive 2 sessions of 45-minute training using x-box machine with combination programs selected from existing commercial programs with a exercise training specialist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity extensor power | Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Fall, Fracture, sarcopenia, Exercise