Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area

Study Overview
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Brief Summary
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BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults. METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.

Official Title
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Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area

Conditions
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Osteoporosis, Fracture

Intervention / Treatment
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* Behavioral: Integrated care (IC)
* Behavioral: Lower extremity exercise (LEE)
* Behavioral: Home care (HC)


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 osteoporosis 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: 1. If patients were unable to meet at least the above inclusion criteria.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC<br>Integrated care (IC) | Behavioral: Integrated care (IC)<br>* Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements 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.<br>|
| Experimental: LEE<br>Lower extremity exercise (LEE) | Behavioral: Lower extremity exercise (LEE)<br>* Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce 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: HC<br>Home care (HC) | Behavioral: Home care (HC)<br>* Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity extensor power measured by isokinetic resistance equipment | 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, Sacopenia, Body Composition