Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

NCT02483286 | Completed

• 1 other identifier: 201503038RINB
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis Fracture

Keywords

Osteoporosis; Fall; Fracture; sarcopenia; Exercise

Outcome Measures

Primary Outcomes (1)

• Lower extremity extensor power

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

  12 weeks

Study Arms (3)

ICG

EXPERIMENTAL

Integrated Care Group

Behavioral: ICG

MTG

EXPERIMENTAL

Muscle Training Group

Behavioral: MTG

XBG

EXPERIMENTAL

X-box Group

Behavioral: XBG

Interventions

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.

ICG

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

MTG

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.

XBG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 50 years of age
• high risk as defined from one of the following criteria:
• score\>=1 on one minute osteoporosis risk questionnaire
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• The Taiwanese Osteoporosis Association.: collaborator
• Wang Jhan-Yang Charitable Trust Fund: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Osteoporotic Fractures; Osteoporosis; Fractures, Bone; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Ding-Cheng Chan

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: May 29, 2015
• Primary Completion: October 5, 2016
• Study Completion: April 15, 2017
• Last Updated: August 22, 2017

Record last verified: 2016-01

Locations

TW (1)