Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Not Applicable

Completed

• Conditions: Osteoporosis Fracture
• Interventions: Behavioral: ICG; Behavioral: XBG; Behavioral: MTG

• Registration Number: NCT02483286
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-29
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Status Verified: 2016-01
• Primary Completion: 2016-10-05
• Study Completion: 2017-04-15
• Last Update Submitted: 2017-08-20
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG	ICG	Integrated Care Group
XBG	XBG	X-box Group
MTG	MTG	Muscle Training Group

Primary Outcome Measures

Name	Time	Method
Lower extremity extensor power	12 weeks	Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan