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Clinical Trials/NCT02483286
NCT02483286
Completed
Not Applicable

Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

National Taiwan University Hospital1 site in 1 country139 target enrollmentMay 29, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis Fracture
Sponsor
National Taiwan University Hospital
Enrollment
139
Locations
1
Primary Endpoint
Lower extremity extensor power
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2015
End Date
April 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Lower extremity extensor power

Time Frame: 12 weeks

Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol

Study Sites (1)

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