Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Osteoporosis Fracture Clinical Trial

Official title:

Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483286
• Other study ID #: 201503038RINB
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: August 20, 2017
• Start date: May 29, 2015
• Est. completion date: April 15, 2017

Study information

• Verified date: January 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: April 15, 2017
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	The Taiwanese Osteoporosis Association., Wang Jhan-Yang Charitable Trust Fund

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity extensor power	Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol	12 weeks