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Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

Primary Purpose

Osteoporosis Fracture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ICG
MTG
XBG
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis Fracture focused on measuring Osteoporosis, Fall, Fracture, sarcopenia, Exercise

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ICG

MTG

XBG

Arm Description

Integrated Care Group

Muscle Training Group

X-box Group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
August 20, 2017
Sponsor
National Taiwan University Hospital
Collaborators
The Taiwanese Osteoporosis Association., Wang Jhan-Yang Charitable Trust Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02483286
Brief Title
Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
Official Title
Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 29, 2015 (Actual)
Primary Completion Date
October 5, 2016 (Actual)
Study Completion Date
April 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
The Taiwanese Osteoporosis Association., Wang Jhan-Yang Charitable Trust Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Fracture
Keywords
Osteoporosis, Fall, Fracture, sarcopenia, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG
Arm Type
Experimental
Arm Description
Integrated Care Group
Arm Title
MTG
Arm Type
Experimental
Arm Description
Muscle Training Group
Arm Title
XBG
Arm Type
Experimental
Arm Description
X-box Group
Intervention Type
Behavioral
Intervention Name(s)
ICG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MTG
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
XBG
Intervention Description
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 Measure Information:
Title
Lower extremity extensor power
Description
Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding-Cheng Chan
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

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Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

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