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Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

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National Taiwan University

Status

Completed

Conditions

Osteoporosis Fracture

Treatments

Behavioral: MTG
Behavioral: ICG
Behavioral: XBG

Study type

Interventional

Funder types

Other

Identifiers

NCT02483286
201503038RINB

Details and patient eligibility

About

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.

Enrollment

139 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

139 participants in 3 patient groups

ICG
Experimental group
Description:
Integrated Care Group
Treatment:
Behavioral: ICG
MTG
Experimental group
Description:
Muscle Training Group
Treatment:
Behavioral: MTG
XBG
Experimental group
Description:
X-box Group
Treatment:
Behavioral: XBG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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