Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02483286
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : August 22, 2017
The Taiwanese Osteoporosis Association.
Wang Jhan-Yang Charitable Trust Fund
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoporosis Fracture Behavioral: ICG Behavioral: MTG Behavioral: XBG

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
Actual Study Start Date : May 29, 2015
Primary Completion Date : October 5, 2016
Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ICG
Integrated Care Group
Behavioral: ICG

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.

Experimental: MTG
Muscle Training Group
Behavioral: MTG
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
Experimental: XBG
X-box Group
Behavioral: XBG
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.

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02483286

National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
The Taiwanese Osteoporosis Association.
Wang Jhan-Yang Charitable Trust Fund
Principal Investigator: Ding-Cheng Chan National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT02483286     History of Changes
Other Study ID Numbers: 201503038RINB
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: January 2016

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Fractures, Bone
Wounds and Injuries