Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
1 other identifier
interventional
151
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedNovember 23, 2015
November 1, 2015
7 months
November 17, 2015
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Study Arms (3)
IC
EXPERIMENTALIntegrated care (IC)
LEE
EXPERIMENTALLower extremity exercise (LEE)
HC
EXPERIMENTALHome care (HC)
Interventions
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.
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.
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.
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10002, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ding-Cheng Chan
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 20, 2015
Study Start
May 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 23, 2015
Record last verified: 2015-11