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Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02483286
Enrollment
139
Registered
2015-06-26
Start date
2015-05-29
Completion date
2017-04-15
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Fracture

Keywords

Osteoporosis, Fall, Fracture, sarcopenia, Exercise

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.

Interventions

BEHAVIORALICG

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.

BEHAVIORALMTG

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

BEHAVIORALXBG

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.

Sponsors

The Taiwanese Osteoporosis Association.
CollaboratorUNKNOWN
Wang Jhan-Yang Charitable Trust Fund
CollaboratorUNKNOWN
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Lower extremity extensor power12 weeksLower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026