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Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02803190
Enrollment
108
Registered
2016-06-16
Start date
2016-06-30
Completion date
2023-12-31
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Fracture

Keywords

Spine curve, Posture, Fracture, sarcopenia, Exercise

Brief summary

The investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (BMD) maintained with different exercise programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices

Detailed description

The current study enrolled subjects who already participated in the 2015 study (n=109) at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in their original integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50) when possible. If target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX for enrollments. New participants are randomized into the ICG and MTG groups. Other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistance training on major muscle groups. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.

Interventions

BEHAVIORALICG

All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with focus on central muscle groups. ICG subjects received once weekly group exercise.

BEHAVIORALMTG

All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program on central muscle groups. MTG subjects received twice weekly machine-based resistance training on major and central muscle groups.

Sponsors

Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund
CollaboratorUNKNOWN
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Lower extremety extensor powerbaseline and 12 weeksLower extremity extensor power is measured by isokinetic resistance equipment by a tranined research assistant with standarized protocol. We will compare the statistical properties between baseline and after 12 weeks intervention.

Secondary

MeasureTime frameDescription
appendicular skeletal muscle indexbaseline and 12 weeksMeasured by bioimpedence analysis machine, before and after intervention. We will compare the statistical properties between baseline and after 12 weeks intervention.
grip strengthbaseline and 12 weeksMeasured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention.
walking speedbaseline and 12 weeksMeasured before and after intervention. Subjects are asked to walk 9 meters. The time between 2 and 7 meter mark are recorded. Walking speed is defined as meter/sec We will compare the statistical properties between baseline and after 12 weeks intervention.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026