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

November 19, 2015 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IC
Integrated care (IC)
Behavioral: Integrated care (IC)
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.
Experimental: LEE
Lower extremity exercise (LEE)
Behavioral: Lower extremity exercise (LEE)
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.
Experimental: HC
Home care (HC)
Behavioral: Home care (HC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity extensor power measured by isokinetic resistance equipment
Time Frame: 12 weeks
Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ding-Cheng Chan, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201402022RINB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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