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Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area

Primary Purpose

Osteoporosis, Fracture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Integrated care (IC)
Lower extremity exercise (LEE)
Home care (HC)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Fall, Fracture, Sacopenia, Body Composition

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 osteoporosis 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. If patients were unable to meet at least the above inclusion criteria.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IC

LEE

HC

Arm Description

Integrated care (IC)

Lower extremity exercise (LEE)

Home care (HC)

Outcomes

Primary Outcome Measures

Lower extremity extensor power measured by isokinetic resistance equipment
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
November 17, 2015
Last Updated
November 19, 2015
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02608749
Brief Title
Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
Official Title
Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults. METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.

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, Sacopenia, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC
Arm Type
Experimental
Arm Description
Integrated care (IC)
Arm Title
LEE
Arm Type
Experimental
Arm Description
Lower extremity exercise (LEE)
Arm Title
HC
Arm Type
Experimental
Arm Description
Home care (HC)
Intervention Type
Behavioral
Intervention Name(s)
Integrated care (IC)
Intervention Description
Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements 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.
Intervention Type
Behavioral
Intervention Name(s)
Lower extremity exercise (LEE)
Intervention Description
Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce 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)
Home care (HC)
Intervention Description
Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week.
Primary Outcome Measure Information:
Title
Lower extremity extensor power measured by isokinetic resistance equipment
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 osteoporosis 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: 1. If patients were unable to meet at least the above inclusion criteria.
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 High Risk Population Intervention and Follow up in the Metropolitan Area

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