Skip to main content
OpenTrials
Completed

NCT Number: NCT02483286

Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Fracture Atrophy Behavior Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Motor Activity Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Osteoporotic Fractures Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older than 50 years of age
  • 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
  • having a bone mineral density test within one year period
  • having the capability to understand the study and complete the study interventions
  • willing to participate for the intervention and study follow ups

Exclusion criteria

  • People younger than 50 years of age
  • Could not communicate because of hearing, visual, or cognitive problems
  • Unable to stand and walk unaided (walking aids are acceptable)

Treatment and study plan

ICG

Behavioral

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.

MTG

Behavioral

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

Behavioral

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • The Taiwanese Osteoporosis Association.
  • Wang Jhan-Yang Charitable Trust Fund

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.