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Completed

NCT Number: NCT02803190

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

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

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Key information

Conditions

Osteoporosis Fracture Atrophy Behavior Fractures, Bone Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Osteoporotic Fractures Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ICG

Behavioral

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.

MTG

Behavioral

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.

Primary outcomes

  1. Lower extremety extensor power

    Time frame: baseline and 12 weeks

    Lower 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 outcomes

  1. appendicular skeletal muscle index

    Time frame: baseline and 12 weeks

    Measured by bioimpedence analysis machine, before and after intervention. We will compare the statistical properties between baseline and after 12 weeks intervention.

  2. grip strength

    Time frame: baseline and 12 weeks

    Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention.

  3. walking speed

    Time frame: baseline and 12 weeks

    Measured 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2023
First posted
Jun 16, 2016
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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