Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
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|ClinicalTrials.gov Identifier: NCT02483286|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : August 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Fracture||Behavioral: ICG Behavioral: MTG Behavioral: XBG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area|
|Actual Study Start Date :||May 29, 2015|
|Actual Primary Completion Date :||October 5, 2016|
|Actual Study Completion Date :||April 15, 2017|
Integrated Care Group
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.
Muscle Training Group
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
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483286
|National Taiwan University Hospital|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Ding-Cheng Chan||National Taiwan University Hospital|